October 2006
Since his arrival in Bethesda in September 2000, NIDCR director Dr. Lawrence Tabak has left a considerable imprint on the institute and its research priorities, advocating for greater emphasis on clinical and translational research, while ensuring a high level of support for investigator initiated grants, or RO1s. Recently, Dr. Tabak spoke with the Inside Scoop about the institute, its budgetary prospects, and some of the challenges that lie ahead for the dental and oral health research community.
Let's start with the NIDCR budget. It has been flat in recent years. Will the trend continue?
I think so. The projections that I’ve seen continue to show a flat line. Nevertheless - and I must emphasize this point - the oral health-research community should not assume the worst. That would be a mistake.
What do you mean?
Well, I mean these are not the worst of times. Not by a long shot. What the budget is telling us is we, as a research community, must continue to prioritize. That’s the take-home message. We must continue to place a higher priority on some areas of research than on others. In short, we must use our resources wisely, and we can’t stop taking some risks.
And NIDCR has several mechanisms in place to lay out those funding priorities. Correct?
The NIDCR’s five-year implementation plan lays out nicely our high-priority areas of research. The institute also has begun to more aggressively employ program announcements, and they, too, should serve as guideposts for the community. I should add that these priorities are not set in a vacuum. They’re set in close consultation with our national advisory council and tremendous amounts of input from the community.
By prioritization, you don't necessarily mean ranking research areas against each other. It's a case of creating a rational pipeline to move basic research into the translational arena?
That’s right. Let me give you an example. A few years ago, NIDCR implemented a strategy to develop and grow more Phase III clinical trials. The strategy called for a step-wise progression and development of clinically relevant ideas. A tremendous amount of credit goes to Drs. Rick Mowery and Bruce Pihlstrom for putting this strategy into place. Today, we have at least one clinical trial coming up for support that went through all of the requisite steps - concept to planning grant to pilot study to clinical trial. Thus, we can see the queue forming, and people are beginning to embrace the process.
And the model is paying off?
I really think so. It’s a win-win situation for all involved. On the one hand, the community has become more successful in securing funding in this way. On the other, the NIDCR now is in a better position to support the most mature and testable ideas, and we can do so in the most scientifically rigorous manner that will yield the most direct and relevant benefit for dentistry and public health.
So to summarize, the bottom line with the NIDCR budget is: It's flat but don't assume the worst?
Exactly. When setting our research priorities, we will continue to actively seek the input of the various sectors of the oral-health research community. Together, we’ll come out okay. We certainly have a great number of resources at hand right now. If we continue to use them wisely, we can continue to make progress.
What about young investigators? By that, as you know, I mean scientists who are just starting careers in oral health research.
That’s the one area where we remain concerned. Historically, as budgets level off, our young investigators tend to get hit the hardest. We’ve taken some steps to try and ameliorate the problem. As a matter of course, NIDCR staff look at every funding application from a new investigator and try to determine whether it should be considered for high programmatic priority. Nonetheless, we remain proactively concerned. We don’t want our new investigators to grow discouraged, shrug their shoulders, and not bother to apply for funding. That’s a bad outcome for everyone. So we will continue to monitor the situation very closely and work with the community to let everyone know the budgetary facts as they unfold.
What about the well being of R01s, or investigator initiated funding applications?
Well, RO1s remain the lifeblood of the institute’s research portfolio. Several years ago, we took a number of steps to ensure the NIDCR will continue to support as many RO1s as possible. These steps came at the expense of our centers program, program project grants, and a few other funding mechanisms. But, again, it’s a matter of prioritization. RO1s are so fundamental to the institute’s mission that we must do whatever we can to ensure their funding stability. Quite frankly, they remain one of our highest priorities, and I think the numbers bear that out. Despite the budgetary challenges, we’ve been able to hold the line on RO1s.
Let's talk about the Practice-Based Research Networks, or PBRNs. They've now been up and running for about a year. How are things progressing?
I like what I see so far. The first protocols have received approval, and the studies have commenced. The NIDCR invested a great deal to allow the PBRNs to create a clinical-research infrastructure, and it may have already paid dividends.
How so?
We’re facing an urgent public-health concern right now that focuses on the thousands of Americans who take a type of drug called bisphosphonates either to control their cancer pain or prevent osteoporosis. There are a growing number of reports both in the medical literature and anecdotally that bisphosphonates can cause osteonecrosis of the jaw in some patients. These reports raise a great deal of concern, and we need answers sooner rather than later to prevent this horrible side effect.
That’s where the PBRNs enter the picture. Because the PBRNs now are in place, we’re using them to get a better handle on the prevalence of the problem and hopefully tease out some of the factors that might trigger the osteonecrosis. There is no doubt that other public health problems will arise down the road, and the PBRNs will allow us to address them rapidly as well.
I've heard you describe the PBRNs as a "bold experiment." Is that still true?
Certainly. We have built in a prospective evaluation of each network, and each team knows clearly what our expectations are. But the networks are definitely moving in the right direction. There already is tremendous cooperation among the three PBRNs, and that’s a wonderful sign. So time will tell. Obviously, we have borrowed from the medical model. Medical research networks have been in place for many years and proved a tremendous success. We hope to accomplish the same. What’s interesting, because we started out de novo , we could insist on interoperability across the networks, and this is an experiment that our physician colleagues have taken note of. We’ve been told by many that interoperability is the ideal.
What do you mean by interoperabiIity?
For example, similar platforms for data collection, common lexicons. So, I think the PBRNs are an experiment in progress. But I think they may have already shown their worth. It remains to be seen what emerges from them. But they’re cooperating, there are some interesting projects in the pipeline, and they’re proposing ideas that every practitioner really wants to know about.
Aside from the PBRNs, you've got the results of the NIDCR's first Phase III clinical trial soon to be published. What is your take on OPT?
I’m very proud of this trial. It’s called the Obstetrics and Periodontal Therapy Study, or OPT. I think the OPT was performed at the highest standard and lays out the power of a multidisciplinary approach to clinical research. In this case, dentists working with physicians working with statisticians.
NIDCR also is supporting another Phase III study, known by the acronym MOTOR. It also addresses the periodontal disease/pre-term birth issue. Why support two studies in this area?
Well, it’s good science to conduct more than one clinical trial in a particular area. The second trial also has a slightly different patient population. The more patient populations that one can study, the more generalizable the data ultimately are. Some end points are also slightly different between the two trials. So yes, I think this is a great opportunity, and we look forward to seeing its results. Clearly, there will be a great deal of interest in how it compares and contrasts to the OPT results.
We talked a few years ago about the oral health community and its role in the NIH Roadmap initiative. The community's response wasn't as vigorous as it could have been. Where do things stand now?
Well, we’re still not quite on the road, and we need to do better. I can’t put it any other way. Our community needs to know that the NIH Roadmap is here to stay. What do I mean by that? The NIH has adopted a strategy of creating a common fund to support the types of research that typically will not be supported by any one institute or center. Lest there be no ambiguity, I am among the strongest proponents of this approach at NIH. I have voted with my feet in that I have co-chaired the Interdisciplinary Working Group, which was one of the major Roadmap working groups in the first set of initiatives.
Clinical research is a prime example.
Exactly. Take the OPT and MOTOR trials that we just discussed. They underscore the potential for multidisciplinary research that our field is capable of achieving. Both trials would have been great Roadmap projects. My hope is that in the coming years our community will position itself to compete more aggressively for these common funds. Certainly, I individually and all NIDCR staff stand ready to help the community in any way. In fact, we welcome the opportunity.
Where is the Roadmap headed?
A Request for Information will soon be issued. Via a web site, people can enter their best ideas. Meanwhile, each institute will enter its best ideas. Several weeks ago, we had a series of consultative meetings to help inform the next iteration of the Roadmap. I was fortunate to co-chair one of the working groups. Dr. Marge Jeffcoat, who is well known to all in our community, was a member of that consultative group. It was a stellar cast - a who’s who of scientists and policy leaders from around the country. Some very interesting ideas came out of session, and I must say almost all of the ideas were conducive to our traditional community playing a role.
What is your sense of why the community didn't avail itself of competing for NIH Roadmap funding?
Well, I’ve received mixed feedback. The perception within the community wasn’t so much that it couldn’t compete. Rather there was a feeling that the highlighted areas of research were not well aligned with the community’s true interests. As time goes on and more common funding opportunities are made available, I think that feeling will start to shift.
As you well know, General Clinical Research Centers, or GCRCs, have been important vehicles for the conduct of high quality clinical research. Recently, the GCRCs were reconfigured into clinical and translational science awards, or CTSAs. What does this transition mean for dental schools?
First of all, NIDCR’s Bruce Pihlstrom has displayed extraordinary leadership behind the scenes working with the NIH’s National Center for Research Resources (NCRR) - the home of GCRCs and the new home of the CTSAs. Okay, bear with me on the acronyms. As you mentioned, the GCRCs are being morphed into the CTSAs. The latter is really designed to provide a bonafide home for clinical research at academic health centers around the country. One of the things that Bruce’s leadership has driven home is that dentistry must be a player in these new CTSAs.
Why? Because if you’re really interested in improving health, then obviously all health, including oral health, is a major component. By ensuring dentistry’s participation up front in these new clinical research entities at academic health centers, I think the opportunities for oral health researchers will open up dramatically around the country. The leadership of academic health centers understand that they’ve got to include dentistry as a part of the mix. So, I think the change will truly bring an enhanced opportunity for our community to do clinical research. Some of the GCRCs were beginning to integrate dentistry, but most did not. I think that in those few cases where dentistry had been integrated, enormous benefits resulted. So, hopefully now, a much wider number of people can join the CTSAs.
Thanks for your time.
Thank you.