Oncology Nursing Society (ONS). BSA participants at the ONS "NCI Listens"session 11-14 May 2000 will be identified at the next BSA meeting. The Chair will be Ms. Deborah Mayer.
ETHICS OVERVIEW - DR. MAUREEN WILSON
Dr. Maureen Wilson, NCI Ethics Counselor, reviewed the procedural code of operation and administration for federal advisory committees as set forth in the Federal Advisory Committee Act (FACA) (P.L. 92-463). Since the BSA is a FACA committee, members are special government employees for the period during which they serve and must assure that their deliberations are free from real or apparent conflict of interest. Examples of activities that are and are not permitted under each statute were presented. Lobbying Congress and concept review issues were clarified.
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AWARD PRESENTATION - DR. RICHARD KLAUSNER
On behalf of the NCI, Dr. Klausner presented retiring BSA Chair Dr. David Livingston with a special Director's Service Certificate "in recognition of exemplary leadership as the first Chair of the Board of Scientific Advisors and for overall contributions to the restructuring of the National Cancer Institute and the National Cancer Program from 1996 to 1999".
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PROGRAM FOR ASSESSMENT OF CLINICAL CANCER TESTS (PACCT) - DRS. ROBERT WITTES AND SHEILA TAUBE
As background, Dr. Robert Wittes, Deputy Director for Extramural Science and Director, Division of Cancer Treatment and Diagnosis (DCTD), reminded members that defining the signatures of cancer cells for early detection and diagnosis was one of the extraordinary scientific opportunities included in the FY 2000 Bypass Budget. Dr. Wittes noted that the challenge for the NCI will be to develop programs to ensure that scientific breakthroughs from these and other gene discovery initiatives result in clinically useful tools for healthcare delivery in cancer medicine. To that end, NCI staff have started planning a Program for Assessment of Clinical Cancer Tests (PACCT).
Dr. Sheila Taube, Associate Director, Cancer Diagnosis Program (CDP), DCTD, reviewed the development process for clinical laboratory tests, identified barriers to progress, and proposed solutions to address some of the issues. The three phases in the development process, as analyzed, are: (1) recognition of a clinical need and/or identification of a potentially useful marker or technology; (2) development of an assay method; and (3) development of a standardized assay
system and evaluation of clinical usefulness.
Major barriers to progress were: (1) the profusion of small studies that appear in the literature in the early phases of development, often with conflicting results, and techniques and data that cannot be compared; (2) the lack of access to statistical collaborators, resulting in studies that often are not designed to have the power to answer all questions posed; (3) the need for large numbers of well-defined and annotated cases or specimens, as well as specimens with long periods of follow-up; (4) the need for standardization of reagents and assay procedures to facilitate comparison of data from multiple studies; and (5) intellectual property issues that could complicate the development of assays and tests that can be performed for acceptable costs.
Proposed solutions: (1) convene a strategy group with relevant expertise from academia, industry, and the NCI; (2) form a statistical consulting group based on identified needs to assist investigators in developing efficient, innovative study designs that adapt existing statistical approaches to new types of analyses; (3) develop a tissue expediter program, an expanded Web site, shared pathology informatics network, and tissue micro-arrays; (4) prepare and supply probes or antibodies and control materials, and evaluate standardized assay protocols; and (5) no solution proposed.
Members were informed of the rationale behind the proposed solutions and some activities under discussion, and they were asked to comment on whether planning for the PACCT had: (1) adequately identified the major barriers; (2) proposed logical solutions that addressed the barriers; and (3) provided alternative solutions to facilitate translation research.
In discussion, the following comments were made:
- Information on assays and associated clinical data included in the literature should be incorporated into the Internet-accessible database, and investigators should be encouraged to submit their data. A group could be convened to discuss this issue.
- MedLine references should contain a tag to facilitate searching. Staff indicated that this topic should be discussed by the Specimen Resources Committee.
- The proposed strategy group should work on a theory-driven way to identify new markers.
- Specimen from cooperative group patients on protocol are an underutilized resource.
- Clinical epidemiologists should be considered for strategy group membership.
- Intellectual property issues have the potential for inhibiting the use of proposed methodologies for nonprofit research, and must be addressed.
- A compromise is needed between allowing a recovery of research expense and the barriers to research created by the practice of granting patents for discoveries.
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NUTRITION IMPLEMENTATION GROUP REPORT - DRS. PETER GREENWALD AND VERNON YOUNG
Dr. Peter Greenwald, Director, Division of Cancer Prevention (DCP), informed members that the Nutrition Implementation Group (NutrIG) report was a follow-up to the 1997 review of NCI's Cancer Prevention Program Review Group (CPPRG) report. Dr. Vernon Young, Professor, Nutritional Biochemistry, and Chair, NutrIG, noted that the CPPRG identified diet and nutrition as one of the two priority areas with respect to reducing cancer incidence at various organ sites.
Dr. Young stated that the charge to the NutrIG was to outline an invigorated, leading-edge nutrition research effort designed to improve the precision with which the impact of diet and its complex chemical makeup could be predicted. The NutrIG report recommendations were: (1) create a trans-NCI coordinating committee on nutrition and cancer led by the DCP; (2) establish a number of programs of excellence in nutritional science and cancer prevention, including several at existing cancer centers; (3) provide developmental funds to encourage nutritional science-related projects in existing cancer centers; (4) hold interdisciplinary workshops linking basic areas of biology and nutritional sciences with cancer etiology and pathogenesis; (5) enhance training and career development in the nutritional sciences aspects of cancer research; (6) assure an appropriate mix of reviewers for diet and cancer research grant applications; and (7) invite nutritional scientists to join the BSA. Dr. Young further recommended that nutritional sciences be represented in future bypass budgets and that nutrition professional societies be encouraged to schedule "NCI Listens" sessions.
In discussion and in response to questions, the following comment(s) was made:
- Industry has an important role to play in terms of translating new nutritional science knowledge into the context of improving the nation's health with respect to cancer prevention. Collaborations may develop as research ideas are implemented in an action plan
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WORKING LUNCH - DR. DAVID LIVINGSTON
Establishing Subgroups to Monitor Large-Scale Initiatives
As background for new BSA members, Dr. Wittes explained that oversight of NCI programs is an important BSA function, exercised principally through prospective review of concepts for new initiatives and retrospective review of extramural programs to be conducted once every 6 years. In addition, the BSA will provide ongoing surveillance of new, high-profile NCI initiatives. The proposed process outlined how programs could be selected for review, the nature of the oversight, products of the oversight, and a tentative list of initiatives for review. Details related to advance preparations, presentation format, and a review calendar were presented.
In subsequent discussion, the following points were made:
- Provide frequent and informal feedback on BSA approved concept initiatives.
- A BSA subgroup will be formed for the preliminary review of the clinical trials restructuring initiative. Materials will be sent to all BSA members prior to a discussion during the open session at the March 2000 meeting.
Motion: A motion to implement the Institute's plan (based on the model used for concept review) to establish subgroups for BSA ongoing surveillance of large NCI programs was unanimously approved; the first will be a review of clinical trials restructuring. The process should be evaluated and modified as necessary.
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UPDATE ON OUTCOMES RESEARCH - DRS. ROBERT HIATT, MARTIN BROWN, AND JOSEPH LIPSCOMB
Dr. Robert Hiatt, Deputy Director, Division of Cancer Control and Population Sciences (DCCPS), reminded members that the update on NCI's outcomes research agenda was requested as a follow-up to the Surveillance Research Implementation Plan presented to the Board in March 1999. For the benefit of new members, Dr. Hiatt outlined events since then, including the organization of the Applied Research Program and Outcomes Research Branch; the complementary reports of the Institute of Medicine (IOM), National Cancer Policy Board (NCPB), and President's Cancer Panel; the development of NCI's response to the IOM-NCPB report; and the formation of NCI's Quality of Cancer Care Committee (QCCC).
Dr. Martin Brown, Chief, Health Services and Economics Branch, DCCPS, reviewed the history of NCI's research in this area, noting that the outcomes research agenda has evolved from descriptive studies, such as patterns of care and variation studies, to studies that are more evaluative in nature, using longitudinal cohorts and collecting data on treatment effects and quality of life. NCI's preventive services patterns of care research began in 1991 with the Surveillance Epidemiology End Results (SEER) pilot studies for the Breast Cancer Surveillance Consortium. The treatment patterns of care research began in 1987 with the SEER-Community Clinical Oncology Program (SEER-CCOP) Patterns of Care studies. The Surveillance Implementation Group (SIG) recommended supporting more studies like Prostate Cancer Outcomes Study (PCOS) to determine the best measures of patterns of care, morbidity, quality of life, etc. Responsibility for implementing the recommendations will reside in the newly organized Outcomes Research Branch.
Dr. Joseph Lipscomb, Chief, Outcomes Research Branch, DCCPS, informed members that the major intent of the quality of cancer care initiative is to review, evaluate, and ultimately foster improvement in the field of cancer outcomes. The intent is to go beyond traditional measures of survival and clinical change to new forms of endpoints focusing on quality of life, patient satisfaction, cost burden to the patient and family. The objective is to enhance the state of the science for defining, monitoring, and improving the quality of cancer care, with the ultimate goal of ensuring that all Americans receive the highest quality of cancer services across the continuum of care. Dr. Lipscomb reviewed the elements of consensus that have emerged from the IOM-NCPB, President's Cancer Panel, and SIG reports, as well as from the 2001 Bypass Budget: (1) develop a core set of outcomes measures that are valid, patient-centered, acceptable to providers, and that span the continuum of care; (2) intensify efforts to understand the effect of interventions on cancer outcomes by strengthening the methodological and empirical research base for quality assessment in cancer; (3) restructure the NCI clinical trials program; and (4) improve communications across the spectrum. These consensus issues constitute the objectives of NCI's quality of care research plan, which will be carried out through the Outcomes Research Branch in partnership with the Secretary's Quality Improvement Initiative (QII) and in cooperation with other DHHS agencies, the Veterans' Administration (VA), and the Department of Defense (DoD). Board members were given a brief description of ongoing and planned activities to implement each of the objectives.
Dr. Lipscomb also described the QCCC as NCI's organizational mechanism to move the quality of care research plan forward. The QCCC will be linked directly to the Federal Quality Interagency Coordinating (QuIC) Task Force, have subcommittees for Research and Care Delivery, and report to the Secretary, QuIC, BSA, National Cancer Advisory Board (NCAB), and NCPB. The end of FY 2000 is the target date for completing an action plan.
In discussion and in response to questions, the following points were made:
- Members requested a report on how the plan's broad elements would be prioritized in the near and long term, and an indication of the estimated budget. For example, one issue to be resolved in regard to expanding the SEER program is the tension between gathering additional information from the sites already covered versus expanding the number of sites. Staff noted that work on core outcome measures, clinical trials, and communications is already ongoing, the latter two with other NCI resources.
- A RFA proposal for the "National Consortium of Research Team for Outcomes Research" will be presented at a future meeting.
Members were asked to e-mail their views of the evolving outcomes research agenda and of initiatives related to improving the quality of care in cancer to Drs. Brown and Lipscomb.
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RFA-COOPERATIVE AGREEMENT CONCEPTS - PRESENTED BY NCI STAFF
Division of Cancer Treatment and Diagnosis
and Division of Cancer Prevention
Image Database Resources for Image Processing Research (RFA-Coop. Agr.) - Dr. Daniel Sullivan, Associate Director, Diagnostic Imaging Program, DCTD, stated that the proposed RFA responds to a need for medical image databases as research resources for medical image processing, which was identified as having a high priority in various NCI/NIH workshops and by the Radiological Society of North America (RSNA). Specific needs include data sets for image processing research, a consortium to develop standardized methods for database generation and evaluation of image processing techniques, and internet access by investigators. The intent of this initiative is to support a consortium of institutions to develop the necessary consensus and standards for a lung computed tomography (CT) image database resource, and to construct a database of spiral CT lung images. As proposed, the consortium would create a consensus on image acquisition parameters and metrics for software evaluation. It is focused on one organ system and one modality. The intent is to develop a process that would serve as a model for other groups to develop additional image database resources.
It was estimated that U01s would be awarded to five individual academic sites from a set-aside of $0.8M for the first year, with a total estimated cost of $4.4M for the 5-year project period.
In discussion and in response to questions, the following points were made:
- The image database to be acquired should have state-of-the-art scanners, especially multi-detector array CT scanners with provisions for storing raw data (e.g., clinical data and an agreed-upon set of clinical data points for correlation studies). In addition, initial planning should include a method for updating the images as technology improves.
- It is important that some method to assure the review and overall quality of the pathology that is leading to the inaccurate diagnosis in these cases be developed. There should be similar pathology standards for the number of sites accruing patients.
- The budget may be too low to address longitudinal studies and raw data storage issues.
Motion: A motion to approve the RFA/Cooperative Agreement concept entitled "Image Database Resources for Image Processing Research" was unanimously approved. NCI leadership was asked to reconsider the proposed budget and decide on an appropriate increase, not to exceed 75 percent of the proposed budget.
Cancer Vaccine Studies Consortium (Coop. Agr.) - Dr. Michaele Christian, Associate Director, Cancer Therapy Evaluation Program (CTEP), DCTD, stated that the proposed project is intended as part of NCI's effort to restructure the early clinical trials program. Vaccines were identified as an area to address because of the demonstrated potential for both preventive and therapeutic applications, and because scientific advances have brought many promising vaccine approaches to the point of clinical development. The goals of the proposed Cancer Vaccine Studies Consortium (CVSC) would be to bring basic and clinical expertise together to: (1) address critical development questions (e.g., optimal vaccine approaches, more efficient clinical trial designs); (2) provide a reliable resource with state-of-the-art immunologic monitoring to evaluate new agents and approaches; and (3) advance the most promising approaches through multi-institutional participation and a logical sequence of studies. As planned, 6-7 clinical trial members would be selected by peer review and assembled into a consortium. Basic science expertise would be leveraged to address the practical problems of vaccine development; clinical expertise would be available to conduct 8-10 trials per year with accruals of 240-300 patients; and the clinical trials members would have the ability to perform state-of-the-art immunologic monitoring techniques. Other features in the organization and structure of the CVSC would be a steering committee, a separately funded central headquarters, flexible funding, and a laboratory oversight committee.
The estimated set aside for the first year is $3M for 7-8 awards, and the estimated total for the
4-year project period is $15M.
In discussion and in response to questions, the following points were made:
- Although the need has been established for well coordinated and standardized clinical trials to test candidate vaccines, the budget estimation of $200,000 for each trial member may be inadequate; hidden costs could be sizeable. Staff noted that a variety of NCI mechanisms would be used to bring production into the Institute.
- Other issues to be addressed include the insufficiency of monitoring assays and the need for additional biologic research, for example, to be able to identify specific tumor antigens in the adult that are beyond the developmental stage. Collaborations should be sought with immunologists who work in transplantation tolerance.
The concept was withdrawn by staff.
Office of the Deputy Director for Extramural Science
Minority Institution Cancer Center Partnership (RFA-Coop Agr.) - Dr. Sanya Springfield, Chief, Comprehensive Minority Medical Branch, Office of Centers, Training and Resources, Office of the Deputy Director for Extramural Science (ODDES), stated that the Minority Institution Cancer Center Partnership (MICCP), if approved, would mark the establishment of long-term collaborations between the NCI and NIH Office of Research on Minority Health (ORMH) to fund, support, and manage the proposed partnerships to successful conclusions. The goal is to devise methods with greater impact on reducing cancer incidence, mortality, and morbidity in ethnic minority populations. Partnerships would be formed between minority-serving institutions (MSIs) and NCI-designated cancer centers to develop cancer programs in research, research training, education, and outreach. MICCP objectives are to: (1) create stable, long-term collaborations that focus on issues relevant to cancer burden; (2) build and stabilize competitive research and research training at MSIs; (3) improve the effectiveness of research, education, and outreach programs to minority communities at the cancer centers; and (4) export successful approaches and models to other NCI-funded cancer centers, minority institutions, and networks.
Funding would be awarded through either planning grants (P20s) or specialized center-cooperative agreements (U54s). The P20 set-aside in the first year was estimated at $5M for 6 awards and 12 awards over the 5-year project period at an estimated $40M. It was anticipated that one U54 will be awarded each year for an estimated $2.5M in the first year and a total of $37.5M.
In discussion and in response to questions, the following points were made:
- The RFA should: (1) include specific examples of the nature of the projects to be considered, types of activities that would be covered by the award, defined outcome measures, and well-developed and articulated principles of accountability; (2) involve in the planning stage all constituencies necessary to ensure identification of the best areas of opportunity; and (3) include concrete education outcomes.
- Staff should consider: (1) conducting a pilot project first; and (2) opening the program to institutions that are not designated cancer centers.
Motion: A motion to approve the RFA/Cooperative Agreement concept entitled "Minority Institution Cancer Center Partnership" was unanimously approved. Concerns relating to the need for specificity should be addressed in developing the narrative and during the evaluation.
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CHEMOPREVENTION IMPLEMENTATION GROUP REPORT - DRS. PETER GREENWALD AND DAVID ALBERTS
Dr. David Alberts, Associate Dean for Research, Arizona Cancer Center, College of Medicine, University of Arizona, and Chair, Chemoprevention Implementation Group (CIG), reminded members that the cross-disciplinary CIG was organized in 1998 to implement recommendations of the Cancer Prevention Program Review Group report. Originally, CIG functions were to set priorities for agents to be evaluated in chemoprevention clinical trials, identify research opportunities, and develop strategies for advancing the field, especially the basic science aspects. Subsequent changes in the structure and function of the chemoprevention program, which reflect CIG recommendations, included a revised set of challenges: (1) build basic science programs within cancer prevention; (2) strengthen the chemopreventive agent development effort; (3) establish an infrastructure and planning process for chemoprevention trials; and (4) develop expertise in the research community. In January 1999, the Basic Science Implementation Subcommittee (BSIS) of the CIG met to begin formulation of specific recommendations for enhancing the basic science component of cancer prevention within the DCP. The CIG recommendations provided advice in four areas: (1) building an infrastructure to enhance the basic science component in cancer prevention research; (2) strengthening genetics, molecular biology, and biomarkers research; (3) strengthening basic nutrition science and cancer prevention research; and (4) strengthening cancer prevention basic science at cancer centers.
Dr. Alberts then briefly reviewed DCP's new matrix structure, which was organized according to CIG recommendations. Organ system research groups make up one axis of the matrix, and prevention research groups the other. Four research groups, basic prevention science, cancer biomarkers, nutrition, and early detection, have been formed to focus on expanding the basic science component. New programs for chemopreventive agent development include providing access to resources for early agent development; developing new preclinical models for evaluating chemopreventive efficacy; incorporating new technology into discovery and characterization; and validating surrogate endpoints for cancer incidence. Two new programs developed collaboratively by DCP and DCTD are molecular target drug discovery grants and the new centers of excellence. These programs have the ultimate goal of encouraging and realizing the full potential of chemoprevention studies as well as fostering the growth of the chemoprevention research community. He also gave: (1) an overview of the proposed decision process for developing and prioritizing prevention clinical trials; (2) a summary of essential review elements for large cancer prevention trials; and (3) recommendations for developing chemopreventive expertise in the research community.
In discussion and in response to questions, the following points were made:
- Areas needing urgent attention are the development of new agents and novel drug delivery techniques. Other areas to address are: (1) linkages with behavioral science expertise to meet the challenges of improving accrual, compliance, and retention; (2) how to engage the non-oncology medical community for these studies; (3) financial implications of mounting large prevention programs; (4) collaborations with MICCP grantees to enhance accrual of minorities and the underserved to clinical trials; (5) changing the terminology to reflect that preventive therapy is actually treatment of precancerous lesions; and (6) coordination between cancer therapeutics and cancer prevention researchers and programs.
- Scientific areas that should be encouraged are: (1) chemopreventive agents delivered locally with the help of image guidance systems; (2) preventive ablation (chemical or physical) for patients at high risk; and (3) discovery and validation of surrogate markers.
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NCI DEVELOPMENTAL THERAPEUTICS PROGRAM AIDS REVIEW GROUP REPORT - DRS. DOUGLAS EDWARDS, ELLEN FEIGAL, AND KARL DIEFFENBACH
Dr. Douglas Edwards, Chief of Infectious Diseases, University of California at Los Angeles, and Chair of the Developmental Therapeutics Program (DTP) Acquired Immune Deficiency Syndrome (AIDS) Review Group, presented the DTP AIDS Review Group report. Dr. Edwards stated that the NCI AIDS research effort began in 1986 with the discovery program for AIDS therapeutics. A trans-NIH review by the Levine Committee of the entire AIDS portfolio in 1997 produced the recommendation to reorganize the DTP AIDS therapeutics screening program to focus on target-based assays rather than the cell-based non-selective assay, a recommendation that was reinforced by the DTP Program Review Group (PRG) in 1998. The charge to the DTP AIDS Review Group was to review changes resulting from the Levine review and define NCI's future role in discovery of agents for HIV/AIDS/opportunistic infections (OI). The DTP AIDS Review Group recommended that the DTP should: (1) establish a single scientific review and oversight advisory board; (2) develop non-cell-based, high-throughput, target-based assays in collaboration with academia, emphasizing targets not actively pursued by industry; (3) continue cell-based assays as secondary assays for confirmation of leads from molecular and biochemical assays and, on a limited basis, for use as primary screening of synthetic compound libraries and purified natural products; (4) maintain, replenish, and expand the natural products repository and acquire/build combinatorial small molecule chemical libraries for use in mechanism- and cell-based screening for AIDS therapeutics; (5) use advisory groups of experts to address issues related to chemical diversity, prioritization of compounds for screening, and supervision of natural products libraries and combinatorial small molecule chemical libraries; (6) develop state-of-the-art methods for data management of compound libraries and implement improved access by the extramural community to DTP resources; (7) establish medicinal chemistry capability to optimize leads generated by screening and play a translational role in identifying industrial partners to move forward the leads; (8) make DTP-supported lead optimization and preclinical activities available to both extra- and intramural investigators and establish an NCI HIV-AIDS Research Office; (9) become a member of the Inter-Company Collaboration for AIDS Drug Development; and (10) receive a budget increase to a level compatible with the perceived needs for development of AIDS therapeutic agents for the treatment of AIDS. In summary, the DTP ARG considered the DTP AIDS program to be of high value and worthy of expansion in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and other Institutes in working on AIDS problems of global concern.
Asked to comment as a member of the DTP AIDS Review Group, Dr. Elliott Kieff, Professor of Microbiology and Molecular Genetics and Medicine, Harvard University, enumerated DTP's significant strengths and those of the new HIV program. Dr. Kieff noted, however, that there is a need for building long-term strategic planning activities into the process.
Dr. Ellen Feigal, Deputy Director, DCTD, reported that a plan of action to address the DTP AIDS Review Group recommendations is to work with the NIAID to develop an integrated NIH plan on AIDS and AIDS-related complications. NCI's DTP and NIAID's Basic Science Program (BSP) staff met to discuss respective grant portfolios and contract resources to identify strengths, weaknesses, and gaps in the spectrum of both their activities and to formulate an integrated plan. The plan has since been presented to the NIH Office of AIDS Research (OAR) and its advisory group. Following review and comment by the BSA, the plan will be returned to the OAR for the allocation of funds.
Dr. Carl Dieffenbach, Associate Director, BSP, NIAID, presented the integrated trans-NIH AIDS Drug Discovery and Development Plan, beginning with a brief historical overview of AIDS therapeutics research in NIAID and NCI since 1985. Dr. Dieffenbach described the collaborations that had developed and acknowledged NIAID strengths (developing new concepts for therapeutics and in Phase III clinical trials, both adult and pediatric) and NCI's strengths (medicinal chemistry and synthesis, pharmacology, and toxicology) in areas needed to move agents into Phase I/II testing. He stated that the objective of the new plan is to optimize the utilization of all NIH resources for the rapid discovery and development of new and improved therapeutics and microbicides for HIV disease and the associated OIs. The plan represents the formalization of a collaborative process embraced by NCI and NIAID over the years to address development questions on a compound-by-compound basis. The plan also furthers the development of a trans-NIH process and establishes a management structure for utilization of the tremendous resources that exist throughout the NIH for drug discovery, preclinical development, and clinical trials. The responsibility of NIH priority-setting for AIDS and AIDS-related research will continue to reside with the OAR; established priorities will be utilized to examine requests for the use of resources and make allocations. The results will be reviewed by the OAR and extramural advisory committees, such as the BSA, based on established review criteria that have been published on the NIAID Web Site.
In discussion and in response to questions, the following points were made:
- In general, the practice in NIAID has been to move agents along intramurally until they are ready for licensing to industry; however, gaps have been identified in industry's research, for example, microbicides and therapeutics for tuberculosis and other OIs.
- NCI's participation in the AIDS drug discovery and development program is important and constructive, and the plan could serve as a model for future inter-Institute cooperation.
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RFA-COOPERATIVE AGREEMENT/RFP CONCEPTS - PRESENTED BY NCI PROGRAM STAFF
Division of Cancer Treatment and Diagnosis
Shared Pathology Informatics Network (RFA-Coop. Agr.) - Dr. Sheila Taube, Associate Director, CDP, DCTD, stated that the overall goal of the proposed Shared Pathology Informatics Network is to create and test a Web-based model system that can request and receive data from existing medical databases at multiple institutions. The initiative represents another step toward the long-term goal of developing informatics systems to support NCI efforts to improve researchers' access to pathology and other clinical information that is linked to tissue specimens. Activities to be undertaken in this initiative are: (1) developing standard data elements and rules for converting free-text pathology reports into data elements; (2) selecting and implementing Internet search software and adapting the software at each member institution; (3) developing procedures for protecting patient confidentiality and obtaining IRB approval; and (4) testing and validating the system. Dr. Jules Berman, Pathologist, Resources Development Branch, CDP, presented evidence that institutions have pathology reports in electronic form and the needed informatics infrastructures and are willing to participate in research that utilizes their data. Evidence was also presented to demonstrate that Internet technology, standardized network query protocols, common medical terminologies, secure encryption capabilities, and standardized pathology report formats are already available to make this initiative feasible.
It is anticipated that awards would be made to 7-10 institutions with a first year set aside of $2.75M and an estimated cost for the 5-year project period of $13.75M.
In discussion and in response to questions, the following points were made:
- Researchers will need access to large numbers of specimens for marker and validation studies.
- The success of the proposed Network will be to ensure that pathology departments at participating institutions receive advance notice and agree to participate, obtaining institutional commitment (in writing, if possible), and enlisting the help of the American Academy of Pathology. Final deliverable descriptions should be minimum requirements.
- Issues to consider in preparing the RFA are: (1) how the specimens will be released; (2) standardization of specimen preparation and storage; (3) the possibility of linking with registries in institutions rather than pathology departments; (4) potential difficulties in linking with legacy information systems in the various institutions; and (5) the need to understand the nomenclature in free-text searches.
Motion: A motion to approve the RFA/Cooperative Agreement concept entitled "Shared Pathology Informatics Network" was approved with one abstention. The concept should be written as Phase I based on input and comments from Drs. Minna, Zerhouni, Schilsky, Anton-Culver, and Alberts.
Ultrasound Research Interface (RFP) - Dr. Daniel Sullivan, Associate Director, Diagnostic Imaging Program, DCTD, presented the concept for the development of an ultrasound research interface with the intent of creating these interfaces as a resource for the research community. The specific contract deliverable would be control software that gives investigators experimental access to, and control over, the raw signals going into ultrasound transducers or the signals coming back. It was noted that the absence of ultrasound research interfaces is a barrier to research on new ultrasound techniques, quantitative image reconstruction, and analysis or interpretation. Examples were given of ultrasound research that would benefit, including high spatial resolution imaging, quantitative flow imaging, molecular imaging, and ultrasound-guided surgery and microsurgery. Improved localization of drug delivery and the combination of ultrasound with other technologies, particularly optical technologies, to maintain and maximize spatial resolution of deep tissue images were cited as potential applications of ultrasound research made possible by the interface software. Originally, the concept proposed two awards from a first year set aside of $2.4M and a total cost of $3.8M for the 2-year project period. Based on a suggestion from Drs. Kressel and Zerhouni, the concept was modified to propose one demonstration award of $1M in the first year and $0.5M in the second year. The single project would be illustrative of a government-industry-academic partnership and would include both the basic and advanced specifications.
In discussion, the following points were made:
- Consideration should be given to a single demonstration project which would be illustrative of government-industry-academic partnership, a single contract to include both basic and advanced specifications up to one million in year one and a half million in year two. This should be on a contract competitive basis so the low bid might come in significantly less than the specified amounts. Two demonstration projects are also acceptable.
- The awardee should agree to provide ongoing support for the interface. Staff thought this was a good suggestion because it would essentially force some cost sharing by industry.
- The promises of the ultrasound are real, and research interfaces have become essential for advancing novel research fields, as well as for cancer surgery.
Motion: A motion to approve the RFP concept entitled "Ultrasound Research" was unanimous.
Adjournment: The meeting was adjourned at 12:05 p.m. on Tuesday, November 9, 1999.
Frederick R. Appelbaum, M.D.
Chair, Board of Scientific Advisors |
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Paulette S. Gray, Ph.D.
Executive Secretary
Board of Scientific Advisors |
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