As part of the U.S. Food and Drug Administration’s (FDA) efforts to enhance transparency around its drug-approval decisions, the FDA is exploring new ways to build on its obligation to share information about product approvals, as announced by FDA Commissioner Scott Gottlieb, MD. The FDA is focusing particularly on information that may improve patient care and better inform providers about the products prescribed and is evaluating how it can release information that may better inform scientists, providers, and patients on clinical study reports.
Clinical Trial Transparency Pilot Program
On January 16, 2018, the FDA launched a new pilot program to evaluate whether disclosing certain information included within clinical study reports following approval of a new drug application improves public access to drug-approval information. In this pilot program, the FDA will select up to nine recently approved new drug applications whose sponsors volunteer to participate and post portions of clinical trial–related summaries from the pivotal trials that were submitted to the FDA by the drug’s sponsor on Drugs@FDA.
The FDA expects that making a clinical study report publicly available after a drug’s approval may provide stakeholders with more information on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process.
We’re commited to enhancing transparency about the work we do at the FDA, especially when it has the potential to foster further research and discovery across the scientific community and better inform patients and providers.— Scott Gottlieb, MD
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As part of this effort, the FDA intends to make available parts of clinical study reports that were most important to its assessment of the safety and efficacy of the drug. Specifically, the FDA plans to include the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies. The clinical study reports will be posted on a new web page on the FDA’s website that describes the pilot program, in addition to appearing on Drugs@ FDA along with the drug’s approval information, soon after a drug is approved. The FDA will also continue to protect patient privacy, trade secret, and confidential commercial information in the clinical study reports released as part of the pilot program.
Once the clinical trial transparency pilot program is complete, the FDA will be seeking public feedback through a Federal Register notice and docket for public comments. The FDA stated it looks forward to learning more about the benefits of expanding this effort and how to support stakeholders’ needs.
Bridging Clinical Trials and Approval
In addition, the FDA hopes to improve ease of access to clinical trials and bridge the gap between ClinicalTrials.gov and FDA drug approvals. Many of the global trials listed on ClinicalTrials.gov relate to research involving new drugs and may eventually form the basis of an application seeking FDA approval, yet tracking a specific clinical trial listed on ClinicalTrials.gov and correlating that trial to its relevance in informing FDA-related activities can be challenging.
The FDA plans to help foster greater transparency around clinical research by adding to FDA materials for future FDA drug approvals the ClinicalTrials.gov identifier number. 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.
“We’re committed to enhancing transparency about the work we do at the FDA, especially when it has the potential to foster further research and discovery across the scientific community and better inform patients and providers. We’ll continue to seek new ways to enable greater access to key scientific information that can advance scientific inquiry and improve public health,” noted Dr. Gottlieb in an FDA press release. ■