In the spring of 2002, the 5‐year doubling of the NIH budget was nearly complete and Dr. Elias Zerhouni had recently assumed the directorship of the National Institutes of Health (NIH). Recognizing that our ability to translate new research discoveries into public health benefits was being constrained by organizational and resource limitations, he convened a series of meetings to explore how the NIH might best facilitate the efficient conduct of medical research in the 21st century. The focus was on opportunities and gaps in research infrastructure that could not be addressed by a single NIH component but, rather, called for a trans‐NIH effort. The result was the NIH Roadmap for Medical Research.
The CTSA program represents a bold and unprecedented investment in the infrastructure of clinical research in the United States.
—Susan B. Shurin, MD
A top priority for the Roadmap was identified as “re‐engineering the clinical research enterprise.” To realize this vision, the NIH has created a research consortium of Clinical and Translational Science Awards (CTSAs) that will include institutions across the United States working as a consortium to bring new treatments to patients, develop innovative approaches to clinical and translational research, support training and mentoring of investigators, extend clinical research into the community, create robust and interoperable research informatics, and develop interdisciplinary teams. A major goal is to enhance research participation by institutions, investigators, and study volunteers and to speed the application of research discoveries to real‐world public health problems.
Funding for the CTSA initiative comes from repurposing some existing programs (e.g., the General Clinical Research Centers, T‐ and K‐awards for training and career development) and from infusion of new Roadmap funds. To date, 24 CTSAs have been funded. It is anticipated that by 2012, the consortium will include 60 CTSAs at an approximate annual cost of $500 million.
Representatives from each of the CTSAs are expected to meet as a group several times each year to enhance development and sharing of common approaches and practices and establish priorities (see CTSAweb.org for committee committees and workshops). Consortium members represent expertise in a wealth of areas, including biostatistics and epidemiology, research design, communications, clinical research ethics and resources for research participants, clinical interaction resources, regulatory issues, pediatric research, bioinformatics, community engagement in clinical research, education and career development for investigators, and support staff, evaluation, and early‐ and later‐stage research translation.
The CTSA program represents a bold and unprecedented investment in the infrastructure of clinical research in the United States. Several key challenges must be addressed from the start if this nascent program is to achieve its mission.
-
▪
Governance of the entire program will need to develop and evolve as the multiple components come together to set priorities, ensure optimal use of resources, and shape the conduct of research and education at the institutions. Oversight and participation will need to be both flexible and transparent as the program expands and matures.
-
▪
The NIH investment must be leveraged with resources contributed by industry, foundations, philanthropy, and other government agencies. It is imperative that the CTSAs develop opportunities and mechanisms to create and support such partnerships.
-
▪
The CTSA infrastructure must intersect with the scientific content and educational programs supported by the categorical Institutes of the NIH. Return on this major public investment will be realized only if the infrastructure is used to conduct specific studies and training programs that are developed by investigators receiving support from the categorical Institutes. Mechanisms must be established to ensure that this happens. For example, the National Heart, Lung and Blood Institute is identifying proposed multicenter clinical trials that might utilize the CTSA infrastructure. The National Cancer Institute is working to avoid duplication of investment at institutions that have both a Comprehensive Cancer Center and a CTSA, and merging redundant clinical research resources. Extensive ongoing communications between the CTSA institutions and the NIH Institutes will be required.
-
▪
The CTSAs must be structured to facilitate access to research and educational resources by scientists, clinicians, study volunteers, students, trainees, and a wide variety of institutions. Mechanisms must be created to foster and develop a diverse, multidisciplinary research workforce. The CTSA program provides an opportunity to enhance participation of institutions and groups not currently deeply involved in research and to build capacity in institutions with little research activity.
Full realization of the vision of the CTSA program will require flexibility to permit components to achieve critical mass and maintain diversity, to emphasize excellence in science, and to build capacity in a wide variety of settings. The breadth of the portfolio is daunting, the opportunity is groundbreaking, and the benefits will be realized only by leveraging this substantial investment through partnerships. Creative leadership by top‐notch experts in the conduct of clinical and translational research will be essential to the success of this ambitious and promising new endeavor.