The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined steps to enhance transparency of clinical trial information to support scientific inquiry related to new drugs.

“We’re especially focused on information that can improve patient care and better inform providers about the products they prescribe,” Gottlieb said in a January 16, 2018 statement. “One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs).”

CSRs are company-generated clinical report summaries. Gottlieb says the current summaries used when reviewing new drug applications (NDAs) provide important context on the basis for the FDA’s approval decisions, but are in a format that can make it difficult for external audiences to extract the detailed clinical evidence that supported approval decisions.

In response, the FDA is launching a new pilot program to evaluate whether disclosing certain information included within CSRs following approval of a NDA improves public access to drug approval information. In the pilot, the agency will select up to nine recently approved NDA whose sponsors volunteer to participate in posting portions of clinical-trial-related summaries on the FDA drug database. The pilot will begin in January 2018.

As part of this effort, the FDA intends to post the parts of the CSRs that were most important to the FDA’s assessment of the safety and efficacy of the drug. The CSRs will be posted on a new web page on the FDA’s website that describes the pilot program, in addition to appearing alongside the drug’s approval information in the drug database, soon after a drug is approved.

In addition to the CSR pilot, Gottlieb also announced a new effort to increase transparency and access to information about the clinical trials associated with particular products.

“A significant number of publicly and privately supported clinical trials register on the National Institutes of Health’s database, ClinicalTrials.gov, which provides access to information on studies in a wide range of diseases and conditions,” Gottlieb said. “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 right now, tracking a specific clinical trial listed on ClinicalTrials.gov and correlating that trial to its relevance in informing FDA related activities—from advisory committee meetings to FDA approval decisions and to the inclusion of the results of a clinical trial into a drug product’s label—can be challenging.”

Regarding this issue, the FDA plans to help foster greater transparency around clinical research by adding to FDA materials, for future FDA drug approvals, a ClinicalTrials.gov identifier number (called the NCT #). The number is expected make it easier to associate the clinical trial listings on ClinicalTrials.gov to FDA communications about specific drugs, including product labeling and advisory committee meeting materials.

Source: FDA