Scientific progress and new drug innovation don’t take place in a vacuum. 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. Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations.
As part of our efforts to enhance transparency around our drug approval decisions, we’re exploring new ways the U.S. Food and Drug Administration can continue to build on its obligation to share information about product approvals. We’re especially focused on information that can improve patient care and better inform providers about the products they prescribe. One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs).
Right now, when a drug is approved, the FDA releases certain information that the agency used when reviewing the new drug application (NDA). This includes summaries written by our medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other important, relevant data supporting safe and effective use. This information is included in our drug approvals database, Drugs@FDA.
These summaries provide important context on the basis for our approval decisions. But they are packaged in a format that can sometimes make it difficult for external audiences to extract all of the detailed clinical evidence that supported the FDA’s approval decisions.
Today we’re 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 this pilot, we will select up to nine recently-approved NDA 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.
These company-generated summaries are called “clinical study reports” (CSRs). A CSR is a portion of the drug file, related to a clinical trial, that contains detailed summaries of the bottom line information on the methods and results of a clinical trial. A CSR is a scientific document addressing efficacy and safety. A detailed summary of the information contained in the CSR can be found on the website