NHLBI has an important legacy of conducting and funding clinical trials that have shaped medical practice and have helped improve the lives of those with sickle cell disease, chronic obstructive pulmonary disease, cardiovascular disease, and other debilitating conditions. NHLBI also has a critically important stewardship responsibility for the institute in the management and oversight of these trials.
Robust management, oversight, and monitoring of trials is integral to NHLBI’s stewardship of clinical trials. Furthermore, as a learning organization, NHLBI seeks continuous improvement in how we do business, and in a changing research landscape, opportunities to improve arise continually.
An important focal point for this effort is the establishment of performance-based, milestone-driven funding opportunity announcements. This approach promotes the selection of trials for NHLBI funding that are operationally feasible and facilitate their completion on budget, on time, and according to the originally-planned objectives of the study. Performance milestones are identified by the investigators in their applications and reviewed by NHLBI, thus establishing shared expectations regarding trial performance. NHLBI will use the performance milestones to monitor and oversee trial conduct and results dissemination.
Partnership with the researchers, patients, clinicians, academic, industry, and other stakeholder communities is a centerpiece of these efforts and critical to our success. In that regard, NHLBI is creating multiple opportunities for engagement and input into our clinical trials optimization activities. In November 2015, NHLBI published a “Request for Information” on Optimizing the NHLBI Clinical Trials Enterprise: Performance Milestones and Metrics. NHLBI received robust input from many diverse stakeholders through this process. NHLBI has also consulted its advisory council, which is composed of scientists and clinicians in academic, industry, and clinical care settings. Collectively, that input informed the development of NHLBI’s new approach to clinical trial FOAs.
Visit this page frequently for news about upcoming meetings, Webinars, requests for comments, and other activities. Questions about these efforts can be directed to NHLBIClinicalTrials@nhlbi.nih.gov.