History of the NCI Clinical Trials Stewardship Initiative

In 2016, NIH announced the first series of reforms and initiatives to improve quality and efficiency of NIH-funded clinical trials focused on a variety of key points along the lifespan of a clinical trial. NIH had modified existing policies and created new ones that govern research involving human subjects and their participation in clinical trials. These initiatives reengineer:

• the process by which clinical investigators develop ideas for new trials
• how NIH reviews and selects clinical trials for support
• how NIH oversees research progress
• how results are reported to ensure rigor and efficiency in clinical trials

Under the NCI Clinical Trials Stewardship Initiative, the NCI has taken steps to implement these changes. To learn more about the new ERA of NIH Stewardship reforms and policy changes, visit these resources:

• NCI Clinical Trials Stewardship Initiative
• NIH Office of Extramural Research - Clinical Trial Requirements for Grants and Contracts