Letter from Dr. Stephen I. Katz: Maximizing the Value of NIH-funded Clinical Trials

Special Announcement
July 21, 2016

Letter From Dr. Stephen I. Katz: Maximizing the Value of
NIH-funded Clinical Trials

Photo: Stephen I. Katz, M.D., Ph.D. Stephen I. Katz, M.D., Ph.D.

Dear Colleagues:

About six years ago, the NIAMS, as part of a larger NIH effort to revamp clinical research, reviewed our mechanisms and processes for funding clinical trials. As a result of that review, we instituted a number of new clinical trial policies and processes. Over the years, weve monitored the progress of those efforts to assess whether changes or additional measures are needed. This months letter focuses on new ways that the NIAMS and the NIH are enhancing support for clinical research.

In 2010, the Institute took a number of steps to strengthen clinical trials, with a focus on feasibility, rigor of the study design, relevance to the NIAMS mission and long-range plan, and, most importantly, the likelihood that results would change clinical practice. At that time, we decided that NIAMS would no longer accept applications for clinical trials through the NIH Parent R01 and R21 Funding Opportunity Announcements (FOAs), and issued a new suite of FOAs dedicated to supporting a broad spectrum of clinical studies. These initiatives encourage high-priority innovative research, provide resources for trial planning and for addressing administrative needs, increase engagement of NIAMS staff with all aspects of trial implementation, and provide funding for observational studies to inform clinical trial design. We also established a dedicated study section to review NIAMS clinical trials.

Over the past year, we have engaged the community in a conversation about our processes for supporting clinical trials. In September 2015, we issued a Request for Information and asked for input from the NIAMS Advisory Council on ways to improve our clinical trials FOAs. A major outcome of these efforts was an update, in April 2016, to the NIAMS clinical trials policy. The policy now allows funding of a clinical study through the NIH Parent R01 or R21 FOA if the primary objective of the study is to understand disease mechanisms. However, consistent with the intent of the policy, applications that include a trial in which the primary objective is to test a clinical outcome will be accepted only through the NIAMS-specific FOAs.

The NIAMS also is actively involved in NIH-wide activities to improve clinical trial regulatory processes, recruitment and retention, data management, and transparency of clinical trial results. These trans-NIH efforts are another important resource to inform our work. For example, in recent years, the NIH has considered how best to support complex multi-site clinical studies, and considered input from a wide range of stakeholders. In June 2016, the NIH issued a new policy that establishes an expectation for the use of a single institutional review board (IRB), rather than multiple IRBs, for multi-site research. This change should streamline IRB review of multi-site studies, reducing the time needed to launch them, while preserving protections for research participants.

We anticipate that the recent NIAMS and NIH policy updates will improve our return on investment in clinical trials. We will continue to look for ways to enhance the conduct and management of clinical studies and to increase support for research with the greatest potential to transform clinical practice and benefit patients.