Information about NIH Clinical Trial Stewardship

The success of the clinical trial enterprise relies on the public trust in scientific rigor, transparency, and ethical oversight. NIH is the largest federal funder of clinical trials in the United States, with a $3 billion annual investment.

It is essential that the NIH:

• support trials investigating high priority questions
• avoid needlessly duplicating previously conducted trials
• exercise proper stewardship over precious public resources, in part by developing and maintaining robust data about the trials we support
• respect ethical obligations to participants who give their time and sometimes put themselves at risk for the sake of advancing science
• promote broad, transparent, timely, and responsible dissemination of information from NIH-funded clinical trials

NIH has utilized a multi-faceted approach to strengthen policies across the life cycle of a clinical trial, from development of the funding opportunity, to the information collected in a grant application or contract proposal, peer review of the application/proposal, and through to monitoring of the award. These policies address challenges and shortcomings in the design, efficiency, and timely reporting of clinical trials.  We have known for years that many NIH-funded trials are completed, yet their main results are either never made public or made public in a timely manner.  Addressing these challenges will ensure the highest likelihood of translating research results into knowledge that will improve human health.

Additionally, historically NIH has had difficulty reporting how many clinical trials it has funded and results from many NIH-funded clinical trials are never published or reported in a public database. Consequently, the Government Accountability Office (GAO) recommended NIH improve clinical trial data collection and establish and implement a process for using this data effectively. These recommendations and related regulations have been incorporated into policies that aim to:

• enhance the application and award processes to increase NIH’s ability to assess the merits and feasibility of clinical trial applications
• improve oversight and transparency
• increase the sharing of clinical trial results

Implementation of these policy changes will ensure rigor, transparency, and effectiveness of the US federally-funded clinical trial enterprise.