1) The National Heart, Lung, and Blood Institute (NHLBI) is seeking input from the clinical trials community on how to optimize the trials NHLBI supports and administers. Of particular interest are performance milestones and metrics for selection, design, planning, conduct, and management of clinical trials including timely reporting of results to enhance scientific and public health impact. Critical elements identified by the community can then be addressed in Funding Opportunity Announcements to help guide investigators in meeting performance milestones.
The NHLBI seeks comments on any or all of the following topics:
- Characteristics of a successful clinical trial (recognizing that a clinical trial can be assessed in a variety of ways, including but not limited to advancing science and completing a trial on time and on budget).
- The best predictors of clinical trial completion.
- Types of information applicants should be encouraged to include in their application to demonstrate the methodological and operational soundness of their clinical trial proposal (i.e., that the trial could realistically be completed on time, on budget, and meet its primary endpoint).
- Performance milestones that should be addressed in clinical trial applications.
- Meaningful metrics that could be used to assess progress toward those milestones.
- Ways NHLBI can work with investigators to facilitate planning in advance of clinical trial applications.
- Ways NHLBI can work with investigators to foster successful completion of their trials.
- Ways NHLBI could engage the community when considering new approaches to the conduct and management of clinical trials (in addition to this RFI).
Please submit your comments by December 28, 2015 to NHLBIClinicalTrials@mail.nih.gov.
2) The NIH’s Physician-Scientist Workforce Working Group (PSW-WG) issued a report in June 2014 containing recommendations for strengthening this sub-set of the biomedical workforce. Since then, the Working Group recognized the PSW report does not sufficiently address diversity. A request for information on Strategies to Increase Diversity in the Physician-Scientist Workforce will be published later this month or early December 2015. The NIH will seek comments on
- Unique trajectories
- Successful strategies to enhance PSW diversity
- Existing successful programs
Additional information will be posted here when the full RFI is released.