FDA Plans to Increase Clinical Trial Data Transparency

FDA Commissioner Scott Gottlieb, MD, recently discussed how the FDA is seeking to encourage innovation by taking additional steps to improve the transparency of clinical trial data.

“The exchange of information that informs decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively are a critical part of enabling the development and dissemination of new medical technology,” Dr Gottlieb said in a press release.

Increasing the transparency of this information can have a beneficial effect on public health due to new innovations, according to Dr Gottlieb.

To ensure that drug approval decisions are transparent, the FDA is investigating new ways to share information with patients. These efforts will focus on information that improves patient care and will better inform providers, according to the statement.

Specifically, Dr Gottlieb said the agency is looking to better inform scientists, providers, and patients through clinical study reports (CSRs).

Currently, the FDA releases information included in a new drug application when a drug is approved. This information provides an overview of the data, labeling, requirements, and other important data.

Although this information is crucial for regulatory decisions, the FDA notes that it can be difficult for the general public to understand the clinical evidence, according to the release.

To remedy this situation, the FDA is launching a pilot program that will determine whether disclosing information in CSRs improves access to approval information, Dr Gottlieb wrote.

In pilot testing, the FDA will select up to 9 recently-approved drugs and post parts of study summaries in the form of CSRs that are submitted to the agency. These CSRs include summaries of bottom line information regarding the methods used in and results of clinical trials, according to the FDA.

The agency predicts that making CSRs publicly available will divulge more information on clinical evidence and increase transparency.

The pilot program will include the study report, protocol, amendment, and statistical analysis for each application for recently-approved drugs that across disease areas.

Once the program is complete, the FDA will seek public comments about how to expand efforts, according to the release.

Dr Gottlieb also announced a new effort to increase transparency around certain drugs. Many clinical trials are registered on ClinicalTrials.gov and findings from these studies can lead to FDA approvals.

As of now, tracking clinical trials and correlating the data to inform FDA-related activities is difficult, according to the release.

In an effort to increase transparency, FDA materials for future approvals will now include the NCT number, which will make it easier to find the clinical trial associated with the data.

“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,” Dr Gottlieb said. “We’ll continue to seek new ways to enable greater access to key scientific information that can advance scientific inquiry and improve public health.”