NIH Reaches Another Milestone Toward Clinical Trial Stewardship Reforms

As the largest public funder of clinical trials in the United States with an annual investment of about $3 billion, and in recognition of the dedicated research participants who volunteer their time and selves to forward medical progress, NIH takes its stewardship of our clinical trial enterprise very seriously. In the past year, we have issued several policies to enhance the design and oversight of NIH-funded clinical trials. We have previously described(link is external) how these initiatives will improve the quality, relevance, feasibility, efficiency, accountability, and transparency of NIH-funded clinical trials. The goal of these reforms is to accelerate the discovery of beneficial interventions for the patients who need them.

Today we’ve taken another step toward these goals. NIH and the Food and Drug Administration (FDA) have created a template to help facilitate the FDA review process for NIH-funded clinical trial protocols. The template, which is initially aimed at Phase 2 and 3 Investigational New Drug (IND)/Investigational Device Exemption (IDE) protocols, meets International Council for Harmonisation E6 (R2) Good Clinical Practice Guidance and helps investigators prepare protocols that contain all the information necessary to enable efficient and timely review by Institutional Review Boards (IRB) as well as comply with FDA regulations. We strongly encourage NIH-funded investigators to take advantage of this helpful tool.

The NIH-FDA template was developed with input from a wide range of stakeholders, and aligns with a template for industry-sponsored trials produced by the non-profit biopharmaceutical organization, TransCelerate BioPharma. Having a common template format with tailored instructions that fit each sectors’ needs will further facilitate FDA review and help increase the efficiency of the clinical trial enterprise. Along with the narrative version of the final template, NIH will also make available an electronic protocol writing tool. It will guide protocol writers through the required protocol sections with instructions and sample text. The electronic writing tool will also facilitate a collaborative approach to writing and reviewing protocols.

The template is the latest in a series of achievements announced in support of clinical trials reform. In June 2016, we announced a policy that NIH-funded, multi-site trials in the United States use a single IRB to streamline the review process and eliminate redundancy. In September 2016, HHS announced a final rule on requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. We also announced a complementary NIH policy for ClinicalTrials.gov registration and results reporting for all NIH-funded clinical trials, including those not subject to the final rule. Both aim to make more information about clinical trials widely available to the public. In January 2017, NIH implemented the expectation that NIH-funded investigators and NIH staff responsible for conducting and overseeing clinical trials receive Good Clinical Practice training.

Together, these changes will help NIH fulfill its mission of supporting scientific discovery to improve human health while elevating the entire biomedical research enterprise to a new level of transparency and accountability.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health