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FDA to Release More Accessible Clinical Trial Data

Scott Gottlieb

Scott Gottlieb, FDA Commissioner, in November 2017 (A. Kotok)

16 January 2018. The U.S. Food and Drug Administration plans to make available in a more user-friendly format details from clinical trials of new drugs approved by the agency. Scott Gottlieb, FDA’s Commissioner, announced the plans today in a statement on the agency’s web site.

FDA currently releases some clinical data used by the agency to approve therapies provided in new drug applications. That information, stored in the agency’s drug approvals database, is prepared by reviewers of the new drug, and normally consists of summaries of evidence supporting approval and requirements for labeling. The problem, says Gottlieb, is the summaries do not offer an easily accessible format for finding data from clinical trials supporting the approvals.

The agency is testing a different method for releasing summaries of clinical trial data through documents called clinical study reports, or CSRs, broken out from the drug approvals database. These documents, prepared by the new drug applicants, contain details of the evidence supporting their applications, including methods used in clinical studies. Examples of these scientific documents can be found on the web site of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Gottlieb says FDA plans to release sections of CSRs considered most important to the decisions of FDA reviewers. “Specifically,” says the statement, “we’ll include the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies.” Those CSR sections will appear in the FDA drug-approvals database, with the current information.

In addition, FDA plans to more closely link evidence from clinical studies used in drug approvals to trials registered at ClinicalTrials.gov, the government’s clinical trials database. The agency plans to reference clinical trials cited in drug approvals with their unique identifiers, called NCT numbers, in ClinicalTrials.gov. FDA says NCT identifiers will be used on agency materials throughout the review process.

The agency is pilot testing the new procedure beginning this month. The test includes CSR documents from up to 9 new drug approvals to treat various types of diseases, and different types of products. FDA is contacting companies about participating, but emphasizes that the agency will continue to protect patient privacy, trade secrets, and other confidential information in these documents. When the pilot test is complete, FDA will seek public feedback through a Federal Register notice.

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