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Vol. LVIII, No. 15
July 28, 2006
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Roadmap Ramps Up Clinical Research
'Academic Home' To Be Created for Clinical, Translational Science

On the front page...

Adding new vigor to clinical research has been a top priority for NIH director Dr. Elias Zerhouni since he arrived here in 2002. No surprise then that one of the NIH Roadmap’s three main initiatives is Re-engineering the Clinical Research Enterprise. The largest component of the initiative is the Clinical and Translational Science Awards (CTSA) program that was announced in fall 2005. Its first awards will be made by the end of September 2006.

Continued...

The CTSA program creates an "academic home for clinical and translational science by encouraging development of novel approaches to the discipline, enhancing informatics and technology resources and improving training and mentoring to ensure that new investigators can navigate the increasingly complex research system," according to planners. With these awards, applicants have the flexibility to determine whether they wish to establish a center, department or institute in clinical and translational science.

CTSA Program Urges Creativity

"Dr. Zerhouni drew on his experience as a clinical investigator at Johns Hopkins," explains NCRR's Dr. Anthony Hayward, who leads the CTSA effort. "The idea was developed through workshops held with clinical research leaders from the extramural community and was followed by the creation of a trans-NIH team early in 2005."

To put Zerhouni's vision into practice, NIH will combine some of the National Center for Research Resource's career development programs with the General Clinical Research Center program to allow
The goal is to “establish a feeder pathway, a pipeline of people with all these different skills coming at a particular
problem from several different angles. We need to cast a very broad net to advance clinical research in the next few years or so.” — Dr. Robert Star
for the scale of transformation that will take place, Hayward says. "Academic health centers across the country are planning new paradigms for interactions between clinical and basic medical science departments and they are working to encourage more gifted young scientists into careers in clinical research." By encouraging creative redesign, the Roadmap hopes to usher scientific discoveries into medical practice more quickly.

"What's unique about CTSA is that it's moving NCRR's GCRC program forward so as to provide essential infrastructure to a larger proportion of NIH's clinical researchers," NCRR acting director Dr. Barbara Alving points out. "It will be the combination of funds from NCRR and the NIH Roadmap for Clinical Research that enables us to make these awards. Roadmap funds in this instance will be used to transform an already-existing program. We plan to have about 60 CTSAs in place around the country. It's revolutionizing the way we do translational clinical research."

Expanding the use of clinical research informatics is another way the Roadmap intends to re-engineer the field. NCRR will also oversee development of a National Electronics Clinical Trials and Research (NECTAR) network. Currently, hundreds of clinical studies are conducted around the country at any given time. Much of the information gained from these studies, however, is not easily and quickly shared among researchers doing similar work. NECTAR will be the backbone for a nationwide group of clinical researchers to collect and synthesize data from studies, reducing duplication of effort.

Two other Roadmap offshoots may also help speed up the rate of research translation:

  • NIH RAID, Rapid Access to Interventional Drugs. RAID was set up as a bridge to get new therapies from the lab to clinical testing faster. Often these study drugs — therapies for uncommon disorders, for example — don't get developed as quickly as potential medicines that attract private- sector investment. That's where an institution like NIH can step in with extra funding or product development advice to help speed the drug along its way. Led by NIDDK's Dr. Josephine Briggs and modeled after NCI's successful Developmental Therapeutics Program, a 2-year RAID pilot began in December 2004.

  • The Patient-Reported Outcomes Measurement Information System (PROMIS) is a way for people with chronic illnesses to report how they feel. Although blood sugar readings, cell counts and other exams can provide data about how treatments are working, results of these tests don't tell the whole story. Often they don't convey quality-of-life symptoms that mean more to patients. PROMIS is an easy-to-use questionnaire that can help document and standardize reports from patients across all disciplines. Health issues that are hard to gauge — pain, mood changes and fatigue, for instance — can be measured using PROMIS's web-based technology.

Team Concept Is Culture Change

In addition to addressing the infrastructure of clinical research, the Roadmap has planned to transform the composition of those conducting the research. Dr. Elizabeth Wilder of NIDDK, a principal leader of Roadmap's interdisciplinary research working group, says planners "had a unique challenge to change academic research culture so that interdisciplinary research is as 'normal' as discipline-specific research that academic research departments are built around."

She points to four initiatives her group designed:

  • training to foster interdisciplinary thinking in investigators at all levels of their careers;

  • methods-development to allow human behaviors to be quantitatively measured so that it and other disciplines can interact more effectively;

  • research to foster development of scientists groups that cross departmental boundaries; and

  • recommendation to change "the NIH policy most often referred to as a leading obstacle for interdisciplinary teams — the recognition of a single leader on NIH-funded projects."

Wilder notes that response so far has been positive. "Recognizing that culture change was the goal," she says, "I think the major advance is that the research community has a heightened awareness of interdisciplinary research, and institutions are increasingly changing their structures and reward systems to facilitate this type of research. The evaluation of our initiatives is only just getting under way, but anecdotal information leads me to believe that the stance taken by NIH — to make interdisciplinary research an area of emphasis through the Roadmap — has made research institutions take notice and adapt to accommodate groups who wish to function in teams." Establishment of the multiple-principal investigator policy is just beginning, she says, but should allow all heads of a project to be recognized as leaders and should therefore encourage team approaches.

Finally, another early success story in transforming clinical research is in the area of training. Because the way clinical research is conducted has changed, teaching the next generation of clinical scientists must change as well, explains NIDDK's Dr. Robert Star, cochair of the trans-NIH clinical research workforce training committee. The traditional "see one, do one, teach one" method of leading a clinical trial is essentially obsolete, he says. The "silo" mentality of single primary investigators running their own studies alone is no longer efficient or effective.

Some investigators think that "the silos are there for a reason — to keep different kinds of grains from mixing," he notes. "But," Star stresses, "we want the grains to work together. We want the synergy that would result from working with each other. For interdisciplinary research to work, there has to be a culture change — both inside NIH and outside."

The goal, he says, is to "establish a feeder pathway, a pipeline of people with all these different skills coming at a particular problem from several different angles. We need to cast a very broad net to advance clinical research in the next few years or so."

For more information about the Roadmap for Medical Research, visit http://nihroadmap.nih.gov/.

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