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AAMC Reporter: June 2007Viewpoint:
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The National Institutes of Health (NIH) has begun a bold initiative to reengineer the way in which clinical and translational research is conducted across the nation. As with many endeavors in this area, the seriousness with which this initiative is viewed is proportional to the financial commitment of both the NIH and the nation’s academic health centers (AHCs). At stake are the $500 million per year the NIH will invest in a consortium of up to 60 Clinical and Translational Science Awards (CTSAs) distributed nationwide. In accepting these awards, institutions are agreeing to work together as a consortium and cooperate with the NIH. The CTSA awardees are focusing on specific topic areas that include informatics, evaluation, training, translational engagement, and oversight of pediatric involvement in all aspects of CTSA activity.
The CTSA awardees have embraced partners that are both numerous and heterogeneous, and include organizations such as pharmaceutical companies, Veterans Affairs hospitals, HMOs such as Kaiser Permanente, and state agencies. Despite the great variation in their collaborations, each CTSA institution has agreed to provide leadership and a home for developing new ways of conducting clinical and translational research. This affects all aspects of the enterprise, from basic research through conduct of clinical trials and on to dissemination and community involvement.
The growth of the CTSA initiative can best be described as occurring in three phases. Phase I was the launch period, which began with the October announcement of the 12 institutions that received CTSAs, as well as the 52 institutions that were awarded planning grants. Phase II of the program involves the ramp-up of the numbers of the CTSAs, as well as the refining of governance and behaviors that are driven by practical experience to consortium operations. Phase III will be a maturation of these efforts, and will reach a plateau in the number of the CTSAs. At this point, the focus of the program can be on enabling the full productivity of the consortium and developing spinoff initiatives that will benefit the overall goals of the CTSA program. Each phase brings challenges and opportunities that must be recognized by NIH staff, CTSA investigators and the AHC leadership.
The CTSA program demands innovation in communication modalities such as informatics, styles of leadership, and institutional organization that affect the AHCs and the National Center for Research Resources (NCRR), which is leading this effort in cooperation with staff drawn from across the multiple institutes and centers of the NIH.
The sustainability of this reengineering effort, which is based on the philosophy of interdisciplinary interactions and connectivity, in large part depends on an academic core of degree-granting programs in clinical and translational science. These will attract individuals who may already be trained as physicians, basic scientists, biomedical engineers, dentists, or nurses, and others who want to add a clinical research degree to their expertise. The potential graduates of these programs may include Ph.D. scientists and M.S. bioengineers—but their CTSA training experience will have brought them experience in the realities of clinical investigation, so that they carry with them an understanding of how best to extend the value of their specialty into the pipeline of translation. At the other end of the spectrum, clinical investigators supported through CTSA-mentored scholarship programs will understand how to communicate with those who are in basic science, thus hopefully fostering more collaborations.
The CTSA institutions are further stimulating interdisciplinary collaborations by funding investigators to engage in peer-reviewed transdisciplinary pilot research projects. Investigators who have been trained in CTSA institutions and who have received a degree in clinical and translational science are in an excellent position to spread the CTSA philosophy, such as the open sharing of ideas and power of working in teams. Thus, the philosophy that is the basis for the CTSA program is one that can be embraced and implemented by AHCs, regardless of whether they have a CTSA award.
The CTSAs can also leverage with other NIH programs. For example, the NCRR also oversees the Research Centers in Minority Institutions program, and the Institutional Development Awards (IDeA) program, developed for institutions in states that historically have received low NIH funding due to small and/or rural populations. These and other NIH-funded programs are in an excellent position to enter into CTSAs as partners or in other arrangements so that mutual benefits can be achieved. For example, 10 of the first 12 AHCs funded for a CTSA also have an NCI-funded cancer center. Directors of these centers are finding ways to interact with the CTSA programs developed at their institutions.
The CTSA initiative will be evaluated in many different ways. Other NIH centers and institutes, for example, want to ensure that the CTSAs are beneficial to their research efforts in the chronic diseases that affect so many of the populations that they serve. How well do CTSAs cut the inefficiencies in time, cost, and labor of clinical trials? How well do new informatics systems improve access to research participation and care? How well do the CTSAs reach out to the community to increase health literacy and provide the opportunity to participate in the development and the conduct of clinical trials? Are the efforts of the CTSAs beneficial to other federal and nonfederal organizations within the complex matrix of the health care enterprise?
National statistics suggest that our society is not receiving the full value of our health care research investments. As the CTSA program moves forward, the NIH and grantee institutions must recognize this and actively contribute to solving or reducing disparities in access to prevention and treatment of chronic as well as acute diseases.
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