Pre-Application Information Session

Cancer Disparities Research Partnership

Bethesda Hyatt - Bethesda, Maryland
January 14, 2002

PDF Version of this transcript (96 Kb)

DR. GOVERN: My name is Frank Govern and today we’ll be answering questions that you may have about the Cancer Disparities Research Partnership Program, and we have a distinguished group of NCI staff at the front table. I’ll let them introduce themselves. Barbara, would you start, please?

MS. FISHER: Hello, I’m Barbara Fisher from the Grants Administration Branch.

DR. WONG: I’m Rosemary Wong. I will be the Program Director administering the grants awarded in the CDRP program.

DR. COLEMAN: I’m Norman Coleman from the Radiation Research Program, Radiation Oncology Sciences Program. I’ll be involved in helping to oversee this program.

DR. LOVINGER: Jerry Lovinger from Review in NCI. I’ll be coordinating the peer review process for the submitted CDRP applications.

DR. DEYE: Jim Deye. I’m a medical physicist working in the Radiation Research Program at NCI and I’ll be involved with answering technical questions with regard to radiation equipment and other physics aspects.

DR. GOVERN: Thank you. Before we get started, I would like to let you know that we’re recording this session as required by regulation. We need to record the questions and the answers. Everything said will be transcribed and placed on our website in a week or two after this meeting. So if you would, please remember to turn your microphones on when you ask your questions and follow-ups and then turn them off when you’re through with your questions. Please try not to talk on top of others because it’s difficult to transcribe. So why don’t we begin to take questions.

DR. COLEMAN: Is it clear why we don’t give an overview of the CDRP RFA?

DR. GOVERN: The reason we don’t give an overview, if you’re expecting that, is because institutions that aren’t able to attend today would be at a disadvantage. So, we were counseled not to do that. We were counseled by the NCI Division of Extramural Administration to give an informational session as it relates to your questions. It would be unfair for us to go through a significant presentation for those who are not here but intend to apply. So that is why we are here, purely to answer your questions. It was specifically written in the announcement for today’s meeting to be a question-and-answer session and informational in that regard. So, let’s begin.

QUESTION: Could you describe the U-56 mechanism? I didn’t see that much information on the web, so I need to have an understanding about that mechanism.

DR. GOVERN: Can anyone on the panel answer that one?

DR. WONG: I can answer that question. It’s actually a grant mechanism. It’s a cooperative planning grant and this U-56, which was developed last year, will be for a five-year grant. The first year is essentially a developmental planning phase whereby you will lay out in detail the developmental plan for your partnership with the selected mentor institution. The second year is when you actually will implement that plan and by the third, fourth and fifth years you will actually be doing the clinical trials. So it is a grant mechanism newly developed one for combining a cooperative planning process with implementation thru a grant award mechanism.

DR. COLEMAN: The grant application will be competitively peer-reviewed using a review panel of outside experts who will come and review the grants and award the appropriate scores. The grants selected for awards by the RRP Program will move their way up through the system to obtain final approval of the National Cancer Advisory Board.

QUESTION. We’d like to concentrate on gynecologic cancers. We were wondering if that would exclude our chances for an award if we exclude males in our selected protocols.

DR. GOVERN: No.

FOLLOW-UP QUESTION: That’s fine to concentrate just on gynecological cancers?

DR. GOVERN: Certainly, as long as they pertain—whatever you do in that area— to populations that are experiencing negative cancer disparities in your area.

FOLLOW-UP COMMENT: Yes. We’re looking at Hispanic and Haitian women.

DR. GOVERN: Correct. That’s great.

QUESTION: The question in your guide was under special requirements; the applicant institution must be a primary provider of care. Is that of oncology care or radiation care or is that a more general description?

DR. GOVERN: More general, overall care for that particular population.

FOLLOW-UP QUESTION: So that institution should have primary programs, family practice programs, etc., etc. to be competitive?

DR. GOVERN: It should. I mean, all institutions should, but to the degree that they do is variable as you know.

QUESTION: How important is geographical diversity with respect to the awardees?

DR. COLEMAN: This is a new mechanism, so we’re not sure what the ultimate grants will look like. In general, how grant reviews go is that each grant is judged on its own merits. So one doesn’t necessarily stratify them in the review process by geography. Programs sometimes down the line have the options to move things around if they feel that’s appropriate to serve the purpose of the grant, but the grants themselves will be reviewed on their own merits.

DR. GOVERN: Although geographic is one item listed as determining possible awards, but certainly if two institutions have very strong applications and they’re within a regional area of each other, that would not preclude both possibly being approved.

QUESTION: Can you use a large part of the monies to purchase equipment, say, approximately 50 percent of the award?

DR. GOVERN: What type of equipment are you talking about?

FOLLOW-UP: High dose-rate radiation equipment.

DR. GOVERN: No. This is targeted for institutions that historically have not been involved in the research enterprise of the NCI. The equipment that is budgeted for in this grant are for teleconferencing, telemedicine and equipment that is needed for whatever research developments that are being done, and as the grant guidelines say, you’re to submit two proposed grant projects or research projects. So if there is some equipment required for that, yes, we’ll consider that, but for the most part the only equipment money there is for significant equipment money is for teleconferencing and telemedicine system in the first year so that the partner and the awardee can easily collaborate. I’m assuming that some of these partners will be from a distance, so this teleconferencing and telemedicine system will help connect them so that they can communicate every day if necessary.

FOLLOW-UP QUESTION: Is that distance a requirement?

DR. GOVERN: No. You could be across the street from each other but then you wouldn’t necessarily need this significant system. You would need less first year equipment funds.

FOLLOW-UP COMMENT: We were thinking that some of the women don’t have access to coming in for six weeks of radiation...whatever...child care...so if they could have access to the high dose-rate radiation, that limits them to three times coming to the hospital so that might increase their treatment options.

DR. GOVERN: Dr. Coleman, would you like to address that?

DR. COLEMAN: Yes, I think one of the intents of the grant is to have the capability to deliver the radiation treatment. So if that’s going to be part of your application you should have the ability to deliver what you’re going to need to deliver to the patient. So this is not supporting treatment delivery per se, it’s really the research aspects and the communication aspects with partners.

QUESTION: If we planned to obtain equipment in the near future to deliver, say, IMRT or something like that, what would you need from us at the time of the application? A purchase order or just a statement to that effect?

MS. FISCHER: What you could do is describe what you plan to purchase. However, if your application was selected for funding, due to the size of this equipment that could be very costly, then at that point we would ask for a breakdown of what you plan to spend with purchase vouchers and things like this to justify this large cost.

DR. GOVERN: It would be helpful to also address what impact the purchase of that equipment would bring to this grant in terms of cancer disparities; how it would be used, utilized, etc.

FOLLOW-UP QUESTION: One of our concerns is that the radiation therapy oncology group clinical trials that we are seeing coming through are going to require a significant investment in capital equipment to be able to get our patients on study. We have made a concerted effort to accrue. We serve a large medically needy population and we’ve made a concerted effort to recruit patients onto study from all population groups and instead of going up, our numbers are going down. This is very concerning to us and we want to be able to offer a state-of-the-art therapy to all people and I think our concern is: where is the funding for the capital equipment that we’re going to need for treating patients on study?

DR. GOVERN: Well again, as Dr. Coleman mentioned, this grant is targeted towards institutions that currently have radiation oncology services in their institutions at a level that is a reasonable state-of-the-art level at this point. It is not—let’s be clear—this grant is not to fund capital equipment purchases of the nature that you’re talking about. It’s to build infrastructure. There are three objectives. One is to build the infrastructure for the introduction of clinical trials in radiation oncology in institutions. Second, it’s to train and actually do those clinical trials in the institution, and three, build a partnership and mentorship through a long-term relationship with a major comprehensive cancer center or RTOG institution in the region in the country. Because of the teleconferencing/telemedicine, distance is no object. But it is not for the purchase of large capital equipment.

QUESTION: If there is an existing relationship with a tertiary center, a comprehensive center, and

we wanted to bring someone else on board as another partner, would that be acceptable?

DR. COLEMAN: Yes, I would think so. The idea is to really build up a robust clinical trials program. So if there are things you’re already plugged into then that would be important to put in the grant.

QUESTION: Since the intent is to get institutions that traditionally are not involved in clinical trials and so forth, by definition might not you expect the PI from the applicant institution to have maybe limited credentials such that they may not be able to write the bulk of this grant themselves. Therefore, is the expectation that the bulk of a competitive grant will be written by the partner institution in keeping the PI in the loop so they know what’s actually on the application? Who do you expect to actually write the grant or the bulk of the grant?

DR. GOVERN: First of all, your first point which is the PI’s background may not be as robust in the research aspects is not necessarily a weakness in this particular grant. This is a unique grant in that regard. We’re looking to build the scientific human resources research effort out there as well as the hardware and the data manager and research nursing. So that is not a weak point to an application. We don’t really care who writes it but be aware that this grant has the requirement of submitting two letters of commitment from two separate potential partners. With your application there needs to be two letters of commitment from two different potential partners. The first year of this grant is to negotiate with those two potential partners and to obtain for your hospital the best relationship that first year and present us with a plan of what that is before the end of the first year.

QUESTION: That was my next question. Why two partners as opposed to one?

DR. COLEMAN: I think part of this grant is to develop research facilities where none previously existed and part of it is to understand how one can reach these populations that have not been successfully reached in the past. So, as opposed to many grants for underserved areas—they’ve gone from the big centers and filtered out to the smaller programs—this is trying to reverse that to some extent. It’s trying to give the community the ability to really build a program, invest in it and so forth. So we wanted to make sure that there are at least a number of options. If there’s only a single option, and for some reason that doesn’t come to pass, then we’ve awarded a grant and there’s not much likelihood of success. Also the disparities institution will have a chance to negotiate on their own behalf. They’ll have the grant and they can get what they think is the relationship they’re interested in. So it’s the reverse flow of funds from the community into the bigger centers that is really quite unique in this grant.

FOLLOW-UP QUESTION: One more point just so I’m clear on that. It would seem intuitive to me that an applicant institution from a large city or a metropolitan area may have a choice of two, three or four or more large cancer centers or partner institutions, but if the applicant institution is from a more rural area they may only have one logical large partner institution to choose from. How do you reconcile that?

DR. COLEMAN: In a couple of ways. First of all, your partner institution doesn’t have to necessarily be local. The institution can be a cooperative group or a comprehensive cancer center and those reach all parts of the United States so we think there are options that way.

DR. GOVERN: I can give you an example. I won’t name the institution but one is anticipating submitting letters from possibly MD Anderson in Texas and University of Wisconsin. So there’s no limit in terms of distance for a partner as long as the partner in the negotiation makes a commitment to do what it says it will do in the partnership.

FOLLOW-UP QUESTION: Could you clarify that two letters are from two mentoring institutions?

DR. GOVERN: That’s correct.

DR. COLEMAN: Do you need more clarification? You still seem puzzled.

FOLLOW-UP QUESTION: Well, I guess in the back of my mind is there any limit to how many organizations can be part of the grant application? Suppose if there were a number of underserved institutions that wanted to work together?

DR. GOVERN: I don’t think there is a limit. However, there is a limit in the dollars. So from that standpoint...we want this to be open and unique. We’re looking for unique approaches to constructing this partnership arrangement, so I’m not discouraging, I’m not encouraging, but that sounds interesting if you can put it together and still have resources adequate to do the job.

FOLLOW-UP QUESTION: So just to reiterate, I guess, we can partner with another underserved institution in a different borough of New York or something as a possibility of a more comprehensive program.

DR. COLEMAN: You can potentially partner as co-applicants if you want to put together a consortium to apply, but you need to have a mentoring institution that has the ability to mentor. So it would be some center or some cooperative group, something that has the ability to help this applicant develop into a healthy clinical research program.

DR. GOVERN: Your question was: can there be co-applicants? Yes.

QUESTION: Our institution has a number of clinical protocols open at the moment and the major sounding block to enrolling patients into these is the very real concerns of transport costs, child and daycare, etc. When I read your specific objectives of this it seems to be aimed very much at recruiting physician scientists, data managers, things like that. Is the primary intent to encourage institutions who already have a certain population to develop more research protocols or is it to try to bring patients in from the community and get them to protocols that already exist or is there any way to enter those two factors?

DR. GOVERN: Actually it’s both.

DR. COLEMAN: I think an important point is that the NCI is a research institution and our job is to help build research infrastructure that works and part of the research aspect of this grant is to figure out what mechanisms can be created from this grant going forward that would solve some of the underserved problems in the United States. So we feel we’re going to learn...it’s not necessarily to deliver lots of health care, it’s to figure out how to reach these populations. Part of this grant is that the grantees will be working together as a team to figure out what worked, what didn’t work, so they can all learn from one another and hopefully more institutions can learn as time goes on.

DR. GOVERN: And that leads into the point that next year there will be another RFA for three additional institutions. The same RFA will be reissued.

DR. COLEMAN: Presumably with all the changes in it.

QUESTION: Will preference be given to institutions that are attempting to initiate federally funded programs or federally funded research programs? For example, an RTOG or a GOG trial or something like that rather than in-house protocols.

DR. GOVERN: If you don’t trigger the other requirements in the grant, fine. But no, it’s how unique and which population you’re serving, how many disparity populations are part of the overall patient population. It’s a number of things that make up the overall grant. No one factor is going to weigh it one way or the other.

DR. COLEMAN: And again, this is speculation, but you can envision a portfolio of grants five or seven years hence, maybe some cooperative groups, maybe some cancer centers, maybe some in-house, but a healthy research infrastructure that really brings the newest and the best to these areas.

QUESTION: Is there a medical physics benchmark or threshold so that you can evaluate whether the applicant institution can indeed do the work, and if so, what is that benchmark or threshold?

DR. DEYE: The benchmark is standard of care for today as stated in the RFA. That can be variable, I suppose, around the country. Each state has regulations with regard to medical physics and who is a qualified teletherapy physicist. It depends on whether the state...well, I guess there are agreement states and non-agreement states. In the non-agreement states the NRC has a role to play there, too, but basically your state regulations. If you go to your state regulations and see who’s listed as a qualified teletherapy physicist and the application here talks about a full-time Ph.D. or M.S. level physics support so that one piece is the full-time Ph.D./M.S. The level of qualification as I say would be the minimum your state regulations and more appropriately, if you’re going to be in trials, you’re going to want someone who is either board certified or board eligible. That wouldn’t be necessary but it would be nice, I suppose is the way to put that icing on the cake.

DR. GOVERN: And about contract services. I know many institutions have contract physics services and that is OK as well for the grant.

DR. DEYE: Yes, if it’s full-time. Five day-a-week type of support, not one or two days a week support.

QUESTION: Is there funding for clinical statistics.

DR. GOVERN: It depends on how you budget.

QUESTION: Part of the clinical trials that might be mentioned in the application that are planned...do they already have to have IRB approval by the time of submission of the March deadline?

MS. FISHER: The answer is no.

DR. GOVERN: Actually, we ask only for a few pages on each proposed research effort so we expect once the awards are made there would be much more detail about that research project, but we wanted you to at least begin to start focusing and getting down to the specifics of what particular research efforts for cancer disparity populations.

QUESTION: Do those pilot studies count towards the page limit?

DR. GOVERN: Who on the panel knows that answer?

DR. COLEMAN: I would think they would. I would think they would. Just a short description.

DR. GOVERN: Didn’t I make that an appendix?

DR. WONG: It’s in the supplemental regulations; the exact examples of what needs to be described in the clinical projects.

FOLLOW-UP QUESTION: But my question is: this is no more than two pages each but it doesn’t indicate if it goes in the body of the grant or is all of this supplemental material and it can go in an appendix?

DR. GOVERN: You know, I think we discussed that and we left it into the page requirement and we limited it to no more than two pages per project.

FOLLOW-UP QUESTION: I guess the same thing goes for the metrics evaluation plan, then?

DR. GOVERN: Yes. We felt that the metrics evaluation could be done in a couple of pages.

QUESTION: What are your past experiences with applicant institutions that actually...you seem concerned about whether the research gets accomplished, so I was just wondering what your ratios are for past grant awardees and what they accomplished?

DR. COLEMAN: This is a whole new grant. I think historically why these new approaches are being taken is that some of the trickle-down approach to funding hasn’t really brought the kind of programs that we in the Cancer Institute would like to see in these underserved areas, so I think this is really a whole new approach to seeing how it works. For those of you who haven’t sat on grant reviews, while there were minimum requirements in a grant application what gets you higher scores or a lower number is the feeling that one can actually carry this out; that it’s not just filling out the boxes, there is a team and the commitment to do that. We think part of what we’ll learn from this is some programs or some approaches will work better than others and the idea of bringing the awardees together is that if awardee three can learn from awardee five then everybody does better and the whole country does better.

DR. GOVERN: Does that answer your question?

FOLLOW-UP QUESTION: What’s the threshold as far as number of applications that you may require to actually fund an application? I assume if there’s only one application this time around you may or may not fund that. Is there a number that you’d like to see of competitive applications or just applications by the deadline?

DR. COLEMAN: I’m not sure that’s ever really a preordained number in a request for applications. I think what’s most important is that it has to be of good standards. So again, I’m not familiar with this process but in my past history if ten applications come in for a grant and none of them are very good or achieve a good priority score then presumably they wouldn’t be funded and another RFA would be issued. So there’s no limit. I think it’s the quality that’s really important or the NCI staff should feel free to correct what I just said if I’ve made an error.

DR. WONG: That’s true. We really want to have real quality applications and if none of the applications that do come in that fulfills all of the requirements that is addressed by this RFA, then what we would do is reissue it or we will only award maybe two instead of three if only two of them are within the quality that we are actually looking for.

DR. COLEMAN: When you send in a grant you get a summary statement that includes what the review is, so there is feedback—successful or not successful—which is very helpful. Often the second time through, certainly in basic research grants, the second time through is a lot different than the first time through, but you will get feedback regardless.

QUESTION: Could I ask about a bit more detail on the $100,000 income limit from grant sources for the applicant institution?

DR. GOVERN: Sure. We decided on that number because there is a grant award called the Institutional Development Award—IDEA, that’s from the National Center for Research Resources. It’s a grant program that helps institutions build infrastructure for research. We did not want to limit or exclude institutions that have received that grant, so that is why up to $100,000 is allowed.

FOLLOW-UP QUESTION: Now, would this include NIH only money or NCI money? What’s the definition precisely there?

DR. GOVERN: It’s NCI money. Isn’t that right? NCI money.

FOLLOW-UP QUESTION: OK. So you could have...the institution, for instance, could have monies from other national institutes and still qualify for application?

DR. GOVERN: Correct and money from pharmaceuticals or industry or your foundations, your own individual institutional foundations. Those resources do not exclude you from applying.

QUESTION: Can you give an example of a pilot study?

DR. COLEMAN: I think I’m sort of reluctant to do that. It’s something that shows the institution is going to use the talent it has, the talent it can draw upon to propose a scientific trial, a clinical trial. I think I really ought not give specifics, but you can envision someone who’s going to be the PI of a study putting together what’s in a study which is a scientific background, a rationale, proposed study that could be done...methodology...just to get a brief summary of why this study is being done, what’s going to be done in it. If you look at any cooperative group clinical trial or any cancer center clinical trial or almost any research study you can get a sense of what goes into those.

FOLLOW-UP QUESTION: The question I would have is: what value does that bring by not giving specifics?

DR. COLEMAN: We are looking for creativity. I certainly know what I would do and I think part of the grant application that you judge on is a little bit of the creativity and probably the only part of scientific creativity is the pilot study. I mean, you can go through almost any clinical trial cooperative group or cancer center grant or many other things and get a sense of what kind of studies one can propose.

DR. GOVERN: Are there any questions about how to display information that shows you qualify? That you treat populations that are listed here? Are there any questions about that? I came prepared to answer those questions as well.

QUESTION: We had a question about the term "cancer base." Exactly what are the boundaries of that?

DR. GOVERN: Your institution or the applicant institution...it is any patient who has been diagnosed with cancer, not necessarily received radiation oncology. But if you have a tumor board you could obtain that type of information.

FOLLOW-UP QUESTION: So it would be our registry? Our tumor registry data only?

DR. GOVERN: Not only, because you have to make a comparison between the state, other counties, to show that your particular situation has a preponderance of this type of patient or that type of cancer that you’re possibly looking at trials to do. The U.S. Census Bureau 2000 census gives you information, demographic information. That’s one source. The SEER Program, if you’re located in a SEER area, they have it by state. They also use Hispanic, non-Hispanic categories. And then we have Dr. Fraumeni’s cancer mortality maps and graphs that you can drill down to the economic areas. Some cities are determined to be economic areas. You can drill down and get a significant amount of information from which you can compare your own data and show that you treat a substantial number of populations experiencing cancer disparities.

DR. COLEMAN: To editorialize, the maps that Dr. Fraumeni’s Division puts together are really spectacular and they’re incredibly up-to-date, so they’re very interesting for health care providers in general.

DR. GOVERN: And then your department of public health has a phenomenal amount of information related to your populations.

DR. COLEMAN: Do you have the Fraumeni website?

DR. GOVERN: Yes, Dr. Fraumeni’s website is www.nci.nih.gov/atlasplus/. But again your department of public health will also have a large amount of information.

QUESTION: One thing that you can commonly find are statistics broken down by incidence rates and mortality rates by ethnicity and so on and so forth. One thing that we’ve had difficulty when we’re looking into this situation right now is to get the similar statistics broken down by economic condition. In other words, the economically deprived. Is there anyone that has generated statistics like that you are aware of? Cancer incidence and mortality versus economic conditions?

DR. GOVERN: I think you might find that in your state department of health information. I know I did when I had to put an example together for the Board of Scientific Advisors to get the concept approved.

COMMENT FROM THE FLOOR: We’ve used our regional cancer information service person. They’ve been able to provide that.

DR. GOVERN: Terrific. So the stronger you can make the case, and you can do it in any unique way you can that your primary service area and patients you service are these populations that are targeted for this grant, I would assume the stronger your application as well.

QUESTION: So on page three, the paragraph towards the bottom where it says the applicant institution must

be the primary provider, what that really means is a significant provider of care? How does one demonstrate that if you are in an urban area with multiple providers that one is the primary provider. Under eligibility requirements, the paragraph beginning "the applicant institution must be the primary provider."

DR. GOVERN: Primary is a term used quite often in the health care industry in terms of their strategic planning and their market analysis. Primary population is the population that surrounds and accesses that institution for care and that institution, hopefully, is the primary provider for that population group, not a referral institution as an example. Where a referral institution does a certain procedure that no one else does, a primary provider is when they need care, no matter what it is, this is where they come. This is the institution to which they come. Primary provider is like primary care physician, same sort of concept.

DR. COLEMAN: Is the question you’re getting to... is the question "the" or "a" primary. It seems like that. We haven’t discussed this but it would seem that you want the patients to get their treatment there so it isn’t just a pass-through sort of institution. If there’s more than one hospital in the area that provides care, I guess both can be "the" is that correct?

DR. GOVERN: Correct.

FOLLOW-UP QUESTION: If it’s a rural institution I guess it’s self-explanatory. That’s the only institution where patients go to but in a more urban setting the referrals that come from medical oncologists or surgeons, those surgeons and medical oncologists may take care of patients at other institutions. However, the radiation facility or applicant institution in this particular case may be at a separate place and so the applicant institution, the applicant radiation oncologist, may not be able to claim that they’re primary care in non-radiation issues.

DR. GOVERN: You’re saying that the institution, the applicant institution, is not a primary care institution for this population but provides radiation oncology?

FOLLOW-UP QUESTIONER: Right.

DR. GOVERN: I don’t know if that would qualify. If purely this radiation oncology service is a referred service purely for the sake of radiation oncology, that institution is not a primary provider for that population. We’re looking for the institutions that are primary providers of these populations cited in the grant. I hope that’s helpful.

FOLLOW-UP QUESTION: It’s just the nature of radiation oncology when some patients get sick they may be hospitalized by an internist, a medical oncologist, a hematologist or a surgeon at an institution of that specialist’s choice. It may be out of the purview of the radiation oncologist is what I’m saying.

DR. COLEMAN: I think this primary care, again, let’s be consistent on this. This primary radiation oncology care...this focuses on the radiation oncology so we’re not looking for an office in a strip mall that sees people and sends them through to a major center. We’re looking for a facility that actually delivers the care. Now if the patients get sent from a surgeon that goes to four different hospitals but this is where the radiation is done, then that would be sort of a primary center for radiation delivery. But we’re not looking for the usual relationship where there’s a small little satellite that sends most of its things in and just does some care, were looking to get a center that can become a center of intellectual activity both for research and for delivering the newest and the best to the population of patients that it traditionally doesn’t get to.

FOLLOW-UP QUESTION: I’m going to ask a question. Does that center have to be a primary care site that is offering the full range of what we think of as primary care in addition to the radiation oncology services you were just describing?

DR. GOVERN: Yes.

DR. COLEMAN: Of course it’s a stand-alone center? Is that what you’re referring to?

FOLLOW-UP QUESTION: To be specific, is that in the RFA?

DR. GOVERN: Not specifically, although it does say that it has to be an institution that is accredited by the Joint Commission on the Accreditation of Health Facilities. So that excludes immediately freestanding cancer centers not affiliated with hospitals. This is directed towards hospitals, a primary care kind of situation.

QUESTION: If it’s a new facility with all the equipment in place and with a long-standing cancer program in place, would it qualify?

DR. GOVERN: Yes, I was asked this question a few times over the phone and I answered that if you can make the argument based on historical data from your long-standing cancer program and extrapolate from that about radiation oncology service, that would still be a valid application. You do have history to build upon in the argument. The fact that it hasn’t opened, I don’t think excludes you from applying as long you’ve had previous history in another way that an argument can be formulated, especially if it’s in a great location for the target populations.

QUESTION: That was going to be my question. Are you leaning more towards the initial startup monies to get a program going and the partnerships established or would you consider applicants who already have made a start and are struggling? We know what the next step is or we think we know what the next step would be if we had the resources. We’ve got the population sitting there needing to be treated and needing to be put on study and it’s just we really need more information. We need people to gather that information and analyze it and tell us what our programs need to look like in the future to build our...just need a next level step and we’ve already made that initial outlay of a considerable amount of resources and now we’re looking to really build on that. So you would consider a program that’s looking to move forward?

DR. COLEMAN: We’re looking for new institutions that will potentially work and that’s why we put the $100,000 limit in. So if you’re there and you have all the intent and you’re struggling but everything’s in the right place, that’s certainly an acceptable application. How study sections work...again, it’s interesting, you want to give the money to people who may actually succeed and some of that shows that you have some track record or some real commitment to that, but also study sections work in wondrous ways, too. They may find something that’s a totally novel approach and say "gee, we’ve never seen anything like this before and this is interesting and let’s give that a go." So I think that sort of the impassioned plea you just gave having sat in study section is always nice to show people are really committed to making this work.

DR. GOVERN: May I just also add that in your eligibility analysis, stage of disease—when patients access health care up – that is usually is found in the state department of health bureau of health statistics, stages, would also help your argument compared to...staging compared to populations that are not targeted here

QUESTION: I have a question about the study section and how that would be constructed. Is this going to a standing review or an ad hoc panel?

DR. COLEMAN: This will almost entirely be an ad hoc, right?

DR. LOVINGER: Yes, this will be an ad hoc committee and we’ll try to get the widest array of people that we can with different expertise. Rosemary, would you explain what kind of people we want on the committee or that you would like to see on the committee?

DR. WONG: The expertise that we are going to be expecting on a review panel will be radiation oncologists, medical physics. We also want patient advocates, we also want...

DR. GOVERN: Sociologists.

DR. WONG: Sociologists, because part of the overall plan is, besides enrolling patients in a clinical trial, you need community outreach in order to provide mechanisms in to enroll your patients, in order to actually maintain them throughout the trial, so there’s a whole infrastructure that you as the applicant organization will have to consider in your developmental plan, and we hope to have expertise in those areas so that they will be able to evaluate the application in terms of the developmental plan and how it’s laid out and how it’s going to be implemented and things like that.

FOLLOW-UP QUESTION: Do you plan to identify an epidemiologist or health services research rep?

DR. WONG: Yes. Those experts will be also be included in this panel. It will be a broad panel to encompass every aspect of this grant.

DR. GOVERN: We may even include cultural anthropologists. As you know, accrual is a problem in these populations. They tend to drop off the queue quite quickly, so applications that address that would be nice.

QUESTION: Specifically addressing the point about accrual, would a suitable pilot study be acceptable if it used accrual as the dependent variable?

DR. COLEMAN: Sure. Again, you want a reasonable question to be asked. Part of the scientific thinking is that at least the question that’s being asked is worth accruing to. So if you don’t think it’s not worth doing, it’s not worth doing well as they say. You need a good idea and accrual is important and I think we can’t overemphasize...when we presented this to the Board of Scientific Advisors they were keenly interested in the sociological aspects of this program. We haven’t succeeded as a country in this area so not only is the science important but how do we succeed in doing that? So the methodology is, again, a very important part of the science that we expect to learn from this. Some will be molecular science and some will be therapeutic science, but some will be systems and methodology sciences.

QUESTION: Are there any specific restrictions we should understand regarding under Supplemental Application Guidelines paragraph D? Sentence number one says "salary for key personnel." Are there restrictions that we need to know about as far as the type of key personnel?

DR. GOVERN: I don’t think so. Ms. Fisher, are there?

MS. FISHER: The only thing that we have currently is that there is a salary cap as most people know. It’s at one hundred sixty one-two and as far as the type of individuals that can be included, I believe you covered that point a few minutes ago. The only other thing I’d like to bring up is the facilities and administrative cost. In a sense, the applicant organization is going to be a small participant in NCI funds of $100,000 or less. If the applicant wanted the facility’s administrative cost/indirect cost, there would have to be a negotiated rate with the regional HHS office, but you will not be able to negotiate the rate until the grant is actually or the application is actually selected for funding. So you will need to submit a proposed rate, if you don’t have one negotiated, in the application and make sure that once you receive any comments that you’re going to be funded that you go forward if you want to submit the F and A to the HHS regional negotiator.

QUESTION: Would you recommend matching funds be put in the application on the part of the institution? Any match formula?

MS. FISHER: These grants usually don’t have matching funds.

DR. COLEMAN: But again, in most applications the sense of commitment to getting this done is important and that’s what we talked about: technical infrastructure. Showing that the institution is willing to invest obviously increases the likelihood of success of the project. Whether it affects the success of the grant, I can’t say.

QUESTION: You separate a city into Hispanic or non-Hispanic. Would it help our case, including the Haitian women?

DR. GOVERN: Of course, yes, if you can quantify that.

QUESTION: Could you go back to support of key personnel? Maybe I’m confused but it says "allowable costs include key personnel such as data management and research nursing." Is that an exclusive list or is that just an example?

DR. GOVERN: An example.

FOLLOW-UP QUESTION: So you can include salaries for principal investigator and co-investigators at each site and etc.?

DR. GOVERN: Absolutely. As the grant said in the background section, many of these institutions can’t afford to free up a physician for time to do research, so we expect some funds available for PI support.

FOLLOW-UP QUESTION: Also along that same guideline, in the partner institution...is it allowable to use some of that funding for statistical and regulatory affairs salary support?

DR. GOVERN: It’s coming from the partner institution. You cannot swap if that’s what you mean; that money. That $100,000 plus indirects are to be used to negotiate your relationship with your partner and to pay them for the resources they use per year to fulfill their obligation under your partnership plan. Now if the plan includes those services then so be it.

QUESTION: I’m jumping ahead a little bit, but the data reporting and that type of thing would, I guess, be based on what the studies actually were, how they looked and be similar to clinical trials data monitoring and reporting? I understand there are other obligations as far as these meetings that you were talking about and people getting together and sharing.

DR. COLEMAN: There are now more and more standards being set, sort of cooperative group or nationwide, to try to standardize how research data are used and transmitted. So I assume that whoever gets the award, if they needed assistance in that, the clinical trials programs could give you advice on where to find those. A lot of these databases are now being set up—web-based—to make it easier so it isn’t a Tower of Babel that it’s been in the past.

DR. GOVERN: I’m the Program Scientist for this program so when awards are made I will be working with the institutions to hook them up and to help the collaboration grow and the clinical trials fall into place.

QUESTION: In terms of the scientific review of some of the clinical trials that we may propose, I presume if we’re going to institute copies of group trials in our institutions that we have a fairly simple paragraph in the application. How much detail would be required of in-house protocols? How rigorous would that scientific group be?

DR. COLEMAN: I think for the application it’s almost to show that there’s been some effort and some sense of the creativity or the initiative that the PIs will take. All of the protocols have to be reviewed by IRBs and have to go through the standard review process and before money is allocated for those by Program, we have to make sure that all the boxes are checked.

FOLLOW-UP QUESTION: A copy of that application to the IRB, for example, would be appropriate?

DR. COLEMAN: Yes, I think that’s sort of a step down the line. I think once it’s awarded then, again, Program could help if the institution doesn’t have experience doing this, the partner could probably help but Program can help as well, too, in sort of giving you the protocol by the numbers approach to get it approved and through.

DR. WONG: Clarification on that. As Program, the way the grant is outlined so that the first year is where you’re actually finalizing your developmental plan and second year is when you’re actually going to implement that, and during that time when you’re ramping on up to actually get your clinical trials, it’s during that second year in which you’re going to get your IRB. If your institution does not have an IRB it is to set up that IRB, set up a data safety monitoring plan, get all your human subjects and regulations in line before you can actually get funded because the Grants Administration will not start funding the extra money for the clinical trials until the third year, and as Program Director, I will be able to help you during that whole time period in order to get all the different steps in line and if need be, Dr. Govern as the Program Scientist is there to provide the resources for you. This U-56 is a cooperative agreement so it is a working relationship between NCI and the applicant so that he can provide you with a lot of the resources on how to go about implementation of the various aspects of this program.

DR. COLEMAN: There’s two ways programs interact. One, there’s Dr. Govern’s part which will be assisting the grantees’ and collaborators in working together. There’s another part of the program making sure you do what you’re supposed to do and those functions are divided. So if you’ve committed to do something—cooperative group or agreements or IRBs—and you don’t do those things, then the administrative hand of NCI Program comes and says you didn’t do what you have to do so you don’t get the money. So we have two roles and different people doing that.

DR. WONG: Maybe just to provide you with some additional information...there’s two advisory committees. There’s a Program Steering Committee that will be formed once the awards are made, the committee members will be the PI of each one of the grantees plus the co-PI of the mentor institution plus Dr. Govern as a Program Scientist. They will meet a minimum of twice a year to discuss the progress of the whole grant. NCI would like is to have a semiannual report of the progress. So from the two meetings of the Program Steering Committee–each grantee will provide a mid-term progress report to each Steering Committee and to the NCI Program Director evaluating each grantee’s ongoing progress and identifying any implementation problems. There’s also the Program Advisory Committee that is made up of three of the Board of Scientific Advisors and the Program Director in order to advise you in terms of any change in scientific directions or implementation, and that committee will meet once a year. Probably both committees will meet once a year at the same time in order to bring everyone together. So be aware that there will be a semiannual report and then the progress report at the end of the first year before the non-competing continuation grant will be awarded.

QUESTION: So there are two meetings of the PSC and then there’s going to be an annual meeting of grantees. Are the PSC meetings...are those to be held in Washington or will the project Program Scientist travel to the local area?

DR. GOVERN: It’s up for discussion.

FOLLOW-UP QUESTION: I guess the question really is: do you budget travel for those semiannual meetings that you were just describing?

DR. GOVERN: Yes.

FOLLOW-UP QUESTION: Specific to whatever it would take within the local area or do we have to budget for the Project Scientist also?

DR. GOVERN: No. You don’t have to budget travel expenses for me.

FOLLOW-UP QUESTION: I mean, if we were to come to Washington twice a year, we would have to budget.

DR. GOVERN: Right.

FOLLOW-UP QUESTION: If you’re going to come out to....

DR. GOVERN: No. I think it’s valuable for me to come out to you and to participate at your end, see the population base and the culture and so forth. Each partnership, each grantee is going to be different and I don’t think it can all be run from Bethesda, Maryland, and be done well.

DR. GOVERN: But Dr. Wong is going to keep all of us honest as the Program Director. The decision of how the each grantee and partner meet and where is up for discussion.

DR. GOVERN: We also will be providing assistance in helping you broker your collaborative relationship if you ask for it. We’re interested in making it work and often it’s helpful to have a third party be there.

QUESTION: I want to go back to a comment from a few minutes ago where I started to get confused about where the grant dollars can go. Just to be clear, it’s OK for the mentoring institution to receive grant dollars, is that correct?

DR. GOVERN: Yes, that’s correct.

FOLLOW-UP QUESTION: Is there any limit to how much of the grant dollars the mentoring institution can receive?

DR. GOVERN: Yes there is. It is $100,000 per year plus indirects.

FOLLOW-UP QUESTION: Where does it say that?

DR. GOVERN: It does not say that. That’s what we budgeted. So this should go out to the Web and people will know that. I caution you about spreading that $100,000. Do not spread it too thin by having two or three institutions involved in mentoring. I’ve had some phone calls about this type of thing and I caution the more you dilute those dollars in spreading them around to other mentors, the less you have in terms of leverage in the relationship.

QUESTION: I thought there was a requirement to have two mentoring institutions.

DR. GOVERN: No, two letters of commitment in the application leading to the selection of one for a long-term relationship.

DR. COLEMAN : What we’re looking for is the awardee to be able, to some extent, to call the shots a little bit so we want to make sure there’s a single option and it can be the big guy-little guy relationship. We’re trying to change that a little bit to have the little guy be the one who can bring the support into them. It sort of puts the shoe on the other foot approach. So we want two to make sure there’s a choice when you submit.

FOLLOW-UP QUESTION: So then by the end of year one you’re supposed to narrow that down to one mentoring institution?

DR. GOVERN: By the end of the first year you are to have a plan developed with one partner and submitted to us.

QUESTION: And the $100,000 limit...does that apply in year one or is there money available for the mentoring institutions in year one?

DR. GOVERN: It is applied in year one. However, we do not expect you to use that full amount because you haven’t implemented a plan until year two. However, we understand their time to come and negotiate and so forth needs to be somewhat reimbursed. So there are monies for you negotiating with them first year. We don’t think it’s going to get to $100,000 to do that. Obtaining two letters of commitment has been a concern from a number of people who have called but we feel it’s a very important aspect of the negotiating process that you will have to do in your first year. If the institution applicant picks only one you immediately lose the leverage of possibly selecting a second or a different partner, although what you do in your own institutions—and we don’t know what you do when you leave here in terms of what relationships you make—but we need two letters of commitment from two different potential partners. You never know when you’ll need that. Everything looks rosy now but you never know. It always helps to have that potential second partner to help you with your negotiations.

QUESTION: Could you give examples other than the cooperative groups? For instance, could you have a federally qualified health care center be a partner to mentor you in handling the population?

DR. GOVERN: You mean a Comprehensive Cancer Center?

FOLLOW-UP COMMENT: No, a federally qualified health care center. Primary care. They provide primary care to indigent populations.

DR. COLEMAN: This is a research grant. It’s clinical research so you’d have to have a mentor who could mentor this institution in developing a cancer research program. So it could be a cancer center, it can be a big clinic that does lots of research, or it could be cooperative groups.

DR. GOVERN: It could be a clinical cancer center, an NCI-designated clinical cancer center or a Comprehensive Cancer Center.

FOLLOW-UP COMMENT: No. What if we have an existing relationship with an NCI Comprehensive Center and the piece that we really need is somebody to mentor us in developing a plan for this population?

DR. COLEMAN: We, in fact, expect a number of the grants will probably have that. The answer is "that’s fine" but the mentoring institution...$100,000 direct money is pretty reasonable money for a cooperative group sort of research, so I think many of them would be very interested in being a partner for this. So if there’s an existing relationship that’s reasonable. That would be one of the letters, but there’s a need for a second letter as well, too, for some reason if they decide they don’t want to do that or they don’t like this relationship, and also it might keep them a little sharper, as Dr. Govern said, in giving attention to this group.

QUESTION: This sort of is a follow-up to that question. Are there any limitations to the nature of that relationship? Specifically, can it be an ownership relationship?

DR. GOVERN: You mean a health care system arrangement where there may be a corporate parent but freestanding institutions? We know that most of health care has moved in that direction or are currently moving in the network system approach. So, no, if it’s the same parent, it does not preclude the applicant applying that’s in the health care system and possibly having a Comprehensive Cancer Center or RTOG institution within the system being one of the potential partners.

QUESTION: Can a wholly owned subsidiary of a health care system be an applicant for this and then mentor back to their parent institution?

DR. GOVERN: If the parent institution fulfills the applicant requirements, yes.

FOLLOW-UP QUESTION: In your original discussion you had emphasized the fact that this was a grass roots effort from the ground up and I think the answer to my question suggested that even though an institution that was an applicant for this was a wholly owned subsidiary of a network or a larger institution it still then would qualify.

DR. GOVERN: If it meets the criteria in the RFA. Yes, it would.

DR. COLEMAN: It would still need a second mentor in the application and in the review process things like wholly owned subsidiary, I suspect, would be noted by any review committee in terms of: does it promote the goals of the RFA initially?

FOLLOW-UP COMMENT: Presumably that would be addressed through the metrics or could be addressed through the metrics.

DR. GOVERN: I think it’s a rare instance where the parent institution who owns that subsidiary would be the applicant.

FOLLOW-UP QUESTION: It all goes back...my question really goes back to that $100,000 limit. If the parent institution and its progeny, we’ll say, how does that $100,000 limit apply? To the progeny alone? Each individual institution that might be owned by the parent has $100,000 limit on it?

DR. GOVERN: Correct. Each individual institution that might be owned by the parent has a $100,000 limit on it.

QUESTION: Does the sponsorship need to be done through the department of radiation oncology at the sponsoring institution or can it be through department of medical oncology or clinical research if they have a better track record in sustaining ongoing trials?

DR. GOVERN: No, it’s a radiation oncology-based RFA.

QUESTION: If one of your potential partnering institution is in the same city and then you’re thinking of another one across the country, how would you handle that in your grant application as far as funding for the teleconferencing? You obviously wouldn’t need it in the same town.

DR. GOVERN: You might need some. Its not just teleconferencing, it’s telemedicine which gets into consultations of patient information, treatment planning images, etc. I wouldn’t think that the applicant institution has much of that no matter where they’re located.

FOLLOW-UP QUESTION: I was just wondering if you have your one mentor institution in the same city or the same radius, the same local area, you could ideally have a teleconference but you wouldn’t really need it. But then if you’re looking at a mentoring institution across the country to satisfy the two letters of commitment then you would obviously need to budget that.

DR. GOVERN: That’s correct. It may be used or it may not be fully used depending on who ends up being your partner. Go ahead and budget it.

DR. COLEMAN: Yes and then in their budget negotiations after award, if you went ahead and contracted your relationship with the local institution they’d probably negotiate out the funds that were set aside for telemedicine unless you still had a strong case to make for the institution across the street.

DR. GOVERN: We’d like to provide some clarification of some areas. So for the record, we’d like to do it here now. The telemedicine and teleconferencing system...you do need to budget for them. However, once the awards are made experts from the Center for Information Technology, which is one of the centers at the NIH, will evaluate comparability of systems that you, the grantee and the partner, may have once you’ve selected your partner and you’ve created your plan. We help by bringing in experts to see how everybody can talk to each other through these capital equipment items, and because of that, because it’s going to take awhile to get to that point, Ms. Fisher has a point to make about the money.

MS. FISHER: Yes. You are to budget for this money in your grant application if you need to have the money in the application. However, the funds will be set in your grant and restricted until there is a review of the equipment at the grantee organization as well as the mentoring organization, and that’s the way we will proceed in the first year.

DR. GOVERN: You may pick a partner that’s across the street that has all of this equipment but yet your second partner may be in another part of the country; if this is the case you will need to put the full amount because we don’t know whom your partner is going to be when you apply and you don’t know either.

QUESTION: What if the Center for Information Technology recommends equipment that’s substantially more expensive?

DR. GOVERN: They won’t do that.

[laughter]

FOLLOW-UP QUESTION: What about budgeting line charges in the out-years? …for telemedicine and so forth.

DR. GOVERN: You need to build them into your budget. We’ve built them in for the five years of the grant. After that you’ll have to find some other way to pay, hopefully.

QUESTION: Well, do you know what the amount is, then, of telemedicine/teleconferencing? I guess it would be similar for all of us.

DR. GOVERN: If you need a system from scratch it would be $180,000 per institution. This is for telemedicine and teleconferencing. So $360,000 has been set aside and will be kept on reserve until we evaluate systems and see what is necessary to make it happen at the partner and the applicant institution.

QUESTION: When you say "set aside" that means we should budget $360,000 into the year one budget?

DR GOVERN: If you are able to identify your partner, work out and negotiate an agreement and provide us with a plan, we get out there and evaluate your systems, the money can be dispensed in year one. Is that right, Ms. Fisher?

MS. FISHER: That’s correct. Yes.

FOLLOW-UP QUESTION: And otherwise it might have to be spent in year two?

DR. GOVERN: Correct.

FOLLOW-UP QUESTION: But either way my point is it needs to be in the budget, indirect costs budget. And then line charges will be on top of that.

DR. GOVERN: That’s right. Maintenance and line charges. Now what does maintenance mean? It means a part of an FTE and engineer in your institution, information systems group who would be taking care of the equipment.

QUESTION: Does that include set-up?

DR. GOVERN: No, we would do the setup.

FOLLOW-UP QUESTION: No, I mean per call like each time we initiate a teleconference if there’s setup to the equipment that needs to be done...

DR. GOVERN: By your engineer. It’s ISDN-based, so it’s phone lines, high-speed phone line-based, so you’ll have that for a year. Each year you’ll have a charge for that ISDN phone line that you would want to keep open. Usually it’s a .2FTE for a engineer to maintain and work the systems. I don’t know if I’m saying too much because then every time I give you a detail we end up reducing the amount of creativity that could be used in these grants.

DR. COLEMAN: You can always spend less, heretical as that sounds.

QUESTION: I want to ask a larger programmatic question. It says "Cancer Disparities Research Partnership" as the title. This past Friday the Dental Institute put out an oral health RFA with a title that included "Cancer Disparities Research." How does this particular RFA and maybe others that follow relate to the new center that Dr. Freeman is involved with here at the NIH? Is there an interaction, you know, long-term goal or interaction of any sort? Just so I can have an understanding of where this came from and why now? That’s all.

DR. COLEMAN: The answer is absolutely. It relates to that. Some of us, myself in particular, were involved with the Subcommittee to Evaluate the National Cancer Program, the SENCaP Report, probably about seven or eight years ago that addresses issues in which Harold Freeman was a participant. So the message he’s delivered helped spark this new program, this new type of program. We’ve talked with him; he’s very much interested in this and in the implementation phase. He’s very much interested in working with this. So he’s both very enthused and very supportive of this approach and a lot of it was his idea, including the President’s Cancer Panel that led to this program being developed and supported very enthusiastically.

DR. GOVERN: The reason you’re seeing other institutes come up with these types of grants is because this is one of the major initiatives of the NIH so it’s happening independently within each institute. If an institute would like to be a co-sponsor of this grant, they were able. We placed our notice of this grant on our internal Web at the NIH and any institute who wanted to participate with us were given a chance to.

QUESTION: I wanted to follow-up a little bit more specific with the question asked earlier of Dr. Deye regarding physics benchmarks. What I really meant...does the applicant institution have to reach the clinical trials cooperative group benchmarks that an RTOG or a SWOG or a ECOG or a QARC, for that matter, might have? I mean, I know that most of the applicant institutions may have a licensed physicist, full-time Ph.D. and be licensed by the Nuclear Regulatory Commission in the state, but there are probably some other benchmarks that they might need to meet if they were to become a member of a cooperative group. Is that the higher standard that you’d like to see?

DR. DEYE: I’d like to see, yes. Required...yes and no. I think what you’re saying about RTOG may be going beyond the basic RTOG clinical trial requirement for medical physics. It is true that there are some new protocols coming online with RTOG that involve intensity modulated radiation therapy that require substantial human resource efforts, but only for those particular IMRT. In fact, there’s only one that’s been approved by RTOG so far; it involves IMRT. For your standard RTOG protocol state licensed physicists would meet the requirement and then the only other requirement I know of above and beyond that, which I think would be a necessity, is the involvement of the Radiological Physics Center out of Texas which, when you’re doing clinical trial work, they send you some TLDs once a year to be irradiated and sent back to them and every three years or so they may come out for a site visit or more often if you’re not meeting the five percent requirement on the TLDs, but that’s a very minimal additional requirement above the Master’s, or Ph.D. TLD’s are dosimeters. They’re just little dosimeters that they send you out of their program from Texas through the mail. You put them under your beam, you give them a set amount of radiation dose and send them back to the Texas center, and they measure the dose that the little chip received, compare it to what you claimed you gave, and tell you if you’re within five percent. So it’s a very good independent check of the absolute dosimetry of your radiation oncology system and that would certainly, I believe, be a requirement here for this program, too, just for patient safety issues as well as efficacy of any study that was going to be carried out. But if you’re aware of additional requirements that I’m not addressing, bring it up. Other than, as I say, the minimal qualification of a full-time physicist whose state license—well, there’s only three states that license, but state accredited, I guess is the word I would tend to use more appropriately—other than that and these little measurement chips that get sent out to the Radiological Physics Center, I know of no additional restrictions on a cancer center today to be a physics qualified member of an RTOG trial unless, as I say, it’s this one trial...head and neck trial that involves IMRT.

QUESTION: The 3-D component that’s required...is there a certain benchmark for what 3-D means ?

DR. DEYE: Right. For some of the studies, I think there are three studies—prostate being one—that involves some 3-D and there are some credentialing requirements there but those are paper requirements by and large. You send in a list of your treatment planning, computer capabilities, and your treatment equipment. Again, it’s just a restatement of your capabilities to show that you can, in fact, carry out 3-D conforming therapy but it doesn’t put an additional requirement on your physics credentials.

DR. COLEMAN: You can also imagine during the course of the grant that an applicant that has the capabilities to have the higher level of technical expertise could be outfitted with that or could be helped to develop that. It’s the whole idea of the standardization of common toxicity criteria for clinical trials. I think over the next few years a lot of clinical research will be more standardized and more standard criteria for consent and for data management and also for quality assurance. So as long as you have the ability to be moved up to that level without expecting the applicants necessarily be an IMRT qualified RTOG member at the application, but someone you could envision, if that were the way they wanted to go, would have the talent and the expertise to do that.

DR. DEYE: I might just say, in case I had forgotten something, if you go on the RTOG website, they list the various protocols and the certification or credentialing requirements for each of the protocols. I think we’ve portrayed them fairly accurately just now, but if I forgot a detail somewhere you can certainly find those details on their website.

DR. GOVERN: Please note, though, that the first year we anticipate you negotiating and finalizing your relationship with the partner, you begin the second year clinical trial infrastructure refinement. It isn’t until the third year that you need to begin to do clinical trials. The reason is some institutions, like your questions, will need time to make sure all the "i"s are dotted and the "t"s crossed as it relates to things such as physics, IRB and data management infrastructure and we’re here to help you arrange that over that year. You could start even earlier if you have the necessary structures and personnel in place, and no one is saying you can’t; it’s that we’re giving you time to make sure it works.

QUESTION: I noticed on your application a package. You asked for the ethnicity of the PI. Does that strengthen or lessen your package if the person is from a minority group?

DR. GOVERN: I don’t think so.

Dr. COLEMAN: I think it would be the target population rather than the PI.

DR. GOVERN. Yes. Dr. Lovinger, who will be actually walking it through the review process, has some comments to make.

DR. LOVINGER: I just wanted to comment on one aspect: the pilot projects and how they might be reviewed. Obviously if you’re going to propose a couple of pilot projects that won’t start until the third year, it’s hard to be very specific and have everything set and that’s the way I anticipate reviewing pilot projects. We will use this—the pilot projects that you suggest—as examples of the kind of thinking of the group and loosely the merit. We’re not going to ask that you put in a complete clinical trial, obviously, with $50,000 per year. You’re not going to have anything like that. So the idea is important; it’s scientific merit. Secondly, the process whereby you got the ideas is important. That is, were several pilot projects submitted to a committee, let’s say, and you picked out this as being perhaps the best? So I think that’s along the lines that we’ll have to review these pilot projects.

QUESTION: Can I pick up on two things you said? One is $50,000 a year. I’m curious where that number comes from.

DR. GOVERN: It comes from the need to budget something for a pilot project.

FOLLOW-UP QUESTION: So a pilot project should be like an R03 or something like that?

DR. COLEMAN: Again, more or less. To get the whole program approved you have to have some sense of where the expenses will go with personnel and we estimated numbers along that line. So the R03 is a reasonable example.

FOLLOW-UP QUESTION: The second question was process by which the pilot projects were identified. You said if they came from a committee. Are you talking about in the actual planning year or in this application phase? In other words, there’s about a month left, which is kind of short to start soliciting pilot research ideas in a formal way.

DR. LOVINGER: That’s certainly true.

DR. COLEMAN: Yes, we like to see creativity. I guess you could propose as part of the mechanisms—even how you interact with your partners—how ideas will get generated and implemented in the applicant organization, so internal peer review is always a reasonable thing, but again, we’re looking for ideas as much as anything. Does this applicant have something that I’d say "gee, if they get this done this is going to really add to this whole reaching the cancer disparities population or doing things in a new and better way? You know, most organizations have some internal peer review or other.

FOLLOW-UP COMMENT: Yes, but an institution that hasn’t done a lot of NCI research probably does not have the infrastructure to do what you’re saying. In other words, the PIs could come up with some ideas but then set up a process as part of the planning grant.

DR. COLEMAN: Yes, and if you look at what we hope to do, this is radiation oncology-based, but the idea is that this will spread to other aspects of cancer care. So you can imagine in your proposal that over the years you’ll build more expertise than you will have when you write the application; so how you intend to engage other experts in your region. One measure of a pilot project would be if you do this pilot project for a year or so it may not answer all the questions but could it be resubmitted as an R01 thereafter?

DR. GOVERN: The RFA talks about at year four the awardee applying for continued funding, so however you see yourself getting there is where the pilot projects should begin.

DR. WONG: Part of this, too, if you’re identifying two partner institutions you can get their feedback on what type of clinical trials that they have ongoing just to give you some ideas of where they may be interested in your patient minority population as part of their accrual in their trials. In this way you can be one of their institutions for providing the patient accrual for an overall RTOG or cancer clinical trial. So that is one aspect that you can explore during this limited time before your grant application has to be submitted.

QUESTION: Could you please go over the amount of money that is available for this grant program and what you think is the size of a typical or upper limit of an application? And I have a follow-up question.

MS. FISHER: The RFA says up to $400,000 in direct costs exclusive of any equipment purchases for the telemedicine/teleconferencing situation.

FOLLOW-UP QUESTION: It also says up to an average. So is that averaged across all the three successful applicants? It might be a three, a five and a six?

DR. GOVERN: Could be.

MS. FISHER: It could fluctuate depending on the applicant’s requirements.

QUESTION: So there is no upper limit for each application?

DR. WONG: But do make sure when you’re putting down your budget request that it is realistic because the reviewers that are going to be on the study panel are more attuned to what the actual costs are for the different line items, etc. that you are proposing in your application, so don’t go wild in terms of that. So be realistic in what you actually want and are proposing for each of the different categories.

QUESTION: The next question I had is that as this conversation has gone on today I’ve learned about a couple, at least two specific kind of earmarks that have gone on and I’m just curious if there are any others that we should be aware of.

DR. GOVERN: What were the two that you...?

FOLLOW-UP QUESTION: One is the $100,000 for the mentoring institution and approximately $50,000 per year for pilot projects. Are there any other specific earmarks that you have in mind for how the budget should be constructed?

DR. GOVERN: Well, the telecommunications/telemedicine system first year. That’s a one-time cost.

FOLLOW-UP COMMENT: Yeah, I mean in terms of the ongoing amount.

DR. GOVERN: Whatever you think you need to do the job and reach the goals of the program.

QUESTION: I’d like to ask a question that’s strictly procedural in nature. On page four of the RFA that was given out this morning there’s a reference to general information of the supplemental application guidelines and maybe I’m just missing it here but I don’t spot it, the general information section.

DR. GOVERN: I think I was referring to the fact that the metrics were very detailed but the partnership plan are general answers. I’m also referring to the generalness of the clinical trials research projects to be proposed, so I think that’s what I meant. Thank you.

QUESTION: Are you allowed to reveal the number of Letter’s of Intent (LOI) that you’ve received by February 6^th if one were to contact you after that date?

DR. WONG; We can disclose the number but I don’t know what relevance that would have. Some applicants will not send in an LOI so it might not be a realistic figure. .LOIs are not actually a requirement but we would like to have a letter of intent so that we can have an idea of how many applications to expect and then Dr. Lovinger would be able to then gear up in terms of review, If you call me I’ll let you know how many we’ve gotten.

DR. GOVERN: I’ve received two by email.

DR. WONG: But it’s still early. We’ve still got three more weeks yet but that doesn’t necessarily mean that they’re going to actually send in an application.

QUESTION: I have a question about the minority and women inclusion section of the 398 application. How are we supposed to address that given that this is not a direct research project?

DR. WONG: I think because in your two projects—the clinical projects—that you are going to be including in the application, in that section of the PHS398 that says "gender minority" you just have to address the issue that you are predominantly you’re going to be focusing a particular population and what you just need to do is address that and don’t just leave it blank, because if you leave it blank the review committee will send your application back.

QUESTION: Do you think it would be acceptable and responsive to describe the catchment area of the applicant institution?

DR. WONG: Yes, definitely, of minorities or women that access the institution. Some historical data of that kind would be useful.

DR. GOVERN: Also please note that the target populations are also those low-income regardless of ethnicity. OK, well, feel free to stay if you have additional questions. Feel free to leave if you feel your questions have been answered. You can always call us. Please come up and pick a card up—business card. I appreciate you all coming. We’ve had a lot of interest in the grant. We’re very happy with the interest.

DR. LOVINGER: Thank you for your questions. They’ve all been very good.

DR. GOVERN: Thanks very much for coming. We encourage you to submit applications to this unique new cooperative agreement.

[END OF MEETING]