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Last Updated: 03/15/2018

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, oversees research progress, and how results are reported to ensure rigor and efficiency in clinical trials.

NCI has taken steps to implement these changes and to achieve more consistency in the conduct and management of clinical trials funded through grants, cooperative agreements, and contracts. Referred to as, “The NCI Clinical Trials Stewardship Initiative,” it continues to build upon NCI’s solid foundation of clinical trials stewardship and is led by a committee of NCI representatives from the various Divisions, Offices, and Centers that support clinical trials. The goal of the initiative is to ensure the following:

  • Quality of clinical trials
  • Safety of research participants
  • Reliability of data
  • Dissemination of results
  • Appropriate stewardship of funds

NIH Policies & Tools for Clinical Trials

As published in JAMA, Toward a New Era of Trust and Transparency in Clinical Trials External Link , authored by Kathy Hudson, Michael Lauer, and Francis Collins on October 4, 2016, NIH launched a multifaceted effort to improve the quality and efficiency of clinical trials by focusing on changes to:

  • The process by which clinical investigators develop ideas for new trials
  • How NIH reviews and selects clinical trials
  • How NIH supports and oversees research progress
  • The process by which results and aggregate data are shared and reported

NIH’s Office of Extramural Research provides additional information on clinical trial requirements for grants and contracts. Specific guidance and tools for various steps in the grant application and contract submission process are listed below.

NIH Definitions and Recommended Training

  • NIH Definition of a Clinical Trial
    Establishes the NIH definition of a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

  • Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
    Establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

Human Subjects Research Policy Changes

NIH Policy Changes to the Application Submission and Scientific Review Process

  • Funding Opportunity Announcements (FOA) for Clinical Trials
    Requires all applications involving one or more clinical trials to be submitted through an FOA specifically designed for clinical trials. The purpose of this policy is to improve the ability for NIH to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with applications, and uniformly apply trial-specific review criteria.

  • FORMS-E Application Package and Instructions
    Includes the new Human Subjects and Clinical Trial related information form that consolidates all human subject and clinical trial information and expands the review criteria information required for studies that meet the NIH definition of a clinical trial.

  • NIH and FDA Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
    An NIH-FDA suggested format for a clinical trial protocol template that NIH investigators can use when writing protocols for phase 2 and 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications.

  • Updated Appendix Policy
    Clarifies the types of materials allowed in the Appendix.

New Policy on Dissemination of NIH-Funded Clinical Trial Information

  • Dissemination of NIH-Funded Clinical Trial Information
    Establishes the expectation that all investigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered at, and that results of these trials are submitted to

NCI Resources for Clinical Trials

NIH Informational Resources

NIH Blogs

NIH Tools/Guidance for Investigators