Office of the Director - June 7, 2016
NHLBI Clinical Trials: A collaborative partnership
The NHLBI’s legacy of excellence in clinical trials rests on the shoulders of investigators, thousands of research participants, and the public who have all partnered with us on trials that have shaped clinical practice and improved the health of millions of Americans. In a balanced research portfolio that emphasizes the support of investigator-initiated fundamental discovery science, investments in the clinical trials enterprise are an essential component of our mission to turn discovery into health. As NHLBI charts its future research agenda, maximizing the scientific value and cost-effectiveness of the clinical trials portfolio is among our highest priorities. Specifically, the NHLBI seeks to engage key stakeholders in developing a more nimble, streamlined, efficient and effective approach to managing trials for maximal yield of scientific impact per dollar invested.
One area of focus for the Institute is to engage the NHLBI community in a systematic evaluation of the impediments to the efficient transition from the initial stages of clinical trial conception to eventual trial closure. The NHLBI’s Strategic Visioning effort, systematic literature reviews documenting clinical trial inefficiencies, and input from the NHLBI community have identified several major challenges in our current clinical trial enterprise that are compromising successful study execution. This collective input identified several key bottlenecks to efficient trial execution, including – sub-optimal plans for trial execution, delays in pre-enrollment approvals (e.g. multiple Institutional Review Boards or IRBs, Investigational New Drug or IND applications), and difficulty enrolling and retaining trial participants. Based on this input and analysis, the Institute seeks to address and potentially preempt these challenges by emphasizing the establishment of clear, early milestones and metrics as an essential means of managing clinical trials for success.
Toward this end, with extensive input from our stakeholders and advisory council, the NHLBI has formulated new milestone-driven Funding Opportunity Announcements (FOAs) for multi-site clinical trials as a starting point for streamlining and optimizing trial operations. The FOAs include the use of a two-phase approach that is designed to better support the Principal Investigator’s task of successfully launching a clinical trial. The first phase focuses support on trial planning and set-up activities, so that investigators will be ideally poised to succeed in the second phase of trial enrollment and execution. In order to allow applicants sufficient time to adapt to these changes in expectations, the first due date for applications under these new FOAs is October 11, 2016, which will be preceded by substantial technical assistance from program staff with FAQs and a Webinar to help facilitate a seamless transition to the amended approach.
As accountable stewards, the NHLBI remains committed to a continuous process of quality improvement in our management of the clinical trials enterprise, and will evaluate the impact of this initiative and other efforts to optimize the cost-effectiveness of our research portfolio. We anticipate that the new two-phase funding structure of these FOAs will enable the Institute to be more nimble and adaptive as we enhance support of investigator efforts to address the challenges and uncertainties of conducting successful clinical trials. We look forward to working with the NHLBI’s circle of partners – the public, research participants, clinicians, professional organizations, the private sector, sister federal agencies, our investigator community and other stakeholders in this collective effort to further extend these efforts to optimize our clinical trials enterprise and maximize its impact on the health of our nation.
Gary H. Gibbons, M.D.