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Transparency: FDA to Release Portions of Redacted Clinical Study Reports

Posted 16 January 2018 | By Zachary Brennan 

Transparency: FDA to Release Portions of Redacted Clinical Study Reports

As part of a push to be more transparent about its decision making and enhance access to data for researchers, the US Food and Drug Administration (FDA) on Tuesday announced it will launch a pilot project to publicly release portions of clinical trial-related summaries from pivotal trials after a drug is approved.

The pilot will select up to nine recently-approved new drug applications (NDAs)  whose sponsors volunteer to participate to release the partially redacted clinical study reports (CSRs), which contain summaries of the information on the methods and results of a clinical trial.

"As part of this effort, we intend to post the parts of the CSRs that were most important to the FDA’s assessment of the safety and efficacy of the drug. Specifically, 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," FDA Commissioner Scott Gottlieb said in a statement.

Once the pilot is complete, Gottlieb said the agency will solicit comments from stakeholders to discuss it. The move follows the European Medicines Agency’s push to release more clinical data for researchers online.

Gottlieb made the announcement of the pilot at a Johns Hopkins event on FDA transparency that delved further into the broader issues of transparency at FDA and included a special issue of the Journal of Law, Medicine, and Ethics.

ClinicalTrials.gov Tracking

In addition to the pilot, Gottlieb announced the agency is adding the ClinicalTrials.gov identifier number, called the NCT number, to FDA materials to better track drugs that make their way from trials through advisory committees through approval.

"This number will make it easier to associate the clinical trial listings on ClinicalTrials.gov to FDA communications about specific drugs, including product labeling and even our advisory committee meeting materials. Members of the patient, academic and scientific communities can easily use this number to identify and track clinical research from a drug’s development throughout the regulatory process. Including this number on FDA materials could greatly benefit all those interested in following the progress of specific clinical research," Gottlieb said.

CRL Release?

In addition to the two announcements, Gottlieb discussed in his speech the possibility of releasing certain redacted complete response letters (CRLs) to help inform the public about how a drug was rejected by the agency.

Gottlieb noted that the agency is looking to release a subset of CRLs "related to clinical safety and efficacy that could have significant public health value," rather than other CRLs that may just relate to "manufacturing shortcomings with new drug applications that are eventually resolved."

He added in a question and answer portion that there is an FDA employee going through about 100 CRLs to determine if there’s a subset of CRLs that could be released.

Joshua Sharfstein, an associate dean at Johns Hopkins, asked Gottlieb if the agency would release CRLs for already-marketed drugs and Gottlieb noted that would be a small subset, and the agency is looking "a little broader than that."


Categories: Regulatory News

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