Clinical trials are a vital part of the research continuum that takes basic research findings at the bench and ultimately translates them into innovations in clinical practice. NHLBI has an important legacy of conducting and funding clinical trials that have indeed provided critical insights into the mechanisms of human disease as well as shaped how physicians address heart, lung, blood, and sleep disorders. Optimizing our clinical trials enterprise is inherent in our stewardship responsibility to the public and to research participants and is consonant with our philosophy of being a learning organization that uses experience and insight to continually improve. The Institute frequently engages our stakeholders as we consider ways to maximize the scientific and public health impact of our trials.
In that vein, NHLBI has just issued a Request for Information (RFI) that solicits your views on the use of performance milestones and metrics for clinical trials. This RFI is the first in a series and will provide vital data to inform NHLBI efforts to optimize the management, oversight, and monitoring of the clinical trials it funds.
The RFI probes important issues including the characteristics of successful trials, the most meaningful metrics for gauging a trial’s progress, and the best predictors of trial completion. We need input from a wide variety of stakeholders on these questions, and I vigorously encourage you to take advantage of this opportunity to contribute to our efforts. NHLBI will initially use feedback from this RFI to consider in developing future Funding Opportunity Announcements (FOAs) for clinical trials. The deadline for submitting your input to us is December 28, 2015. In the meantime, some frequently asked questions about the RFI are answered here.
Changes in the research landscape and advances in technology make this a particularly opportune time to explore new strategies for promoting successful clinical trials. Toward that end, NHLBI is committed to working in partnership with our various communities to develop a shared understanding of the factors that are critical to the success of a clinical trial with an eye toward ensuring that the research the Institute funds yields the greatest scientific and public health benefit possible.
We look forward to your insights.
Gary H. Gibbons, M.D.