The National Institutes of Health (NIH) and the majority of its Institutes and Centers support a broad spectrum of research—ranging from basic to translational to clinical—in their mission to prevent, detect, diagnose, and treat disease and disability. In recent years, the NIAMS has assessed its support of clinical research in all of its mission areas, with the goal of maximizing the impact of NIAMS-sponsored trials, so that they will make a difference in patient care.
In 2009, the Institute engaged many parts of its community through discussions with its Advisory Council and at its 2009 Scientific Retreat, as well as through a series of Clinical Trials Roundtables in each of the NIAMS mission areas. The primary goals of these meetings were:
- To identify and prioritize clinical research gaps and opportunities
- To define key steps for evaluating trials and the significance of individual studies in the context of future clinical needs
These efforts have resulted in a new panel of funding mechanisms to promote clinical trials development, including an R21 funding opportunity for pilot and feasibility clinical research grants in arthritis, musculoskeletal and skin diseases. It supports the initiation of exploratory, short-term clinical studies that are likely to gather critical, preliminary data for use in future clinical trials.
We have also launched a two-stage program of cooperative grants to support clinical trials. The first stage will be supported by a U34 clinical trial planning grant, which is mandatory before applying for a U01 clinical trial implementation grant. Applicants are urged to submit letters of request prior to creating full U34 or U01 applications. Proposals for large trials are expected to make a difference in clinical practice.
A working group composed of members of the NIAMS Advisory Council will play an important role in evaluating these letters, applications, and the entire process, to help assess responsiveness to the overall goal of supporting clinical trials with the greatest impact. The working group will also scan the horizon for the greatest needs and opportunities for clinical trials in the NIAMS mission areas.
The Institute has also established a standing study section to review NIAMS clinical trials applications. Its members have expertise in rheumatic, musculoskeletal, and skin diseases as well as clinical trials and biostatistics methodology. The NIAMS website consolidates all of this information on its Clinical Trials web page.
At the NIH level, a recently issued press release announced a new web portal on clinical trials titled, NIH Clinical Research Trials and You. This web portal offers a wealth of information for building awareness about clinical trials, and encouraging the participation of patient populations and the general public in these studies. This website will be a useful resource for clinical investigators to enhance study participant recruitment activities. It will also be a powerful tool for voluntary and professional organizations; they can disseminate this well-packaged material to their communities, colleagues and patients, to facilitate involvement in clinical trials.
We believe that these enhancements and resources will provide important support to the NIAMS community in its efforts to improve lives through discovery. We encourage you to share this information with interested colleagues and associates.
Stephen I. Katz, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health