NHLBI has issued the first in a series of Requests for Information (RFIs) to solicit input from its stakeholders on ways to optimize the clinical trials enterprise. This first RFI seeks stakeholder views on clinical trial management, performance milestones, and metrics.
NHLBI has an important legacy of conducting and funding clinical trials that have provided critical insights into mechanisms of human disease and have shaped medical practice improving the lives of those with sickle cell disease, chronic obstructive pulmonary disease, cardiovascular disease, and other debilitating conditions. In funding and overseeing these trials, NHLBI has an important stewardship responsibility to the research participants and the public.
Changes in the research landscape and advances in technology make this a particularly opportune time to explore new strategies in this regard, with an eye toward fostering successful trials. NHLBI will work in partnership with the clinical trials community to develop a shared understanding of the factors that are critical to the success of a clinical trial. These critical factors can then be addressed in Funding Opportunity Announcements (FOAs) to help guide investigators in developing project management plans, identifying important clinical trial milestones, and in developing effective approaches to meet those milestones in a timely manner.
NHLBI is interested in hearing from all of its stakeholders on ways to optimize the management, oversight, and monitoring of NHLBI clinical trials. To view the RFI and for instructions on submitting comments, connect to: https://grants.nih.gov/grants/guide/notice-files/NOT-HL-15-284.html