Photo by Esther Dyson
Preparing drug for a trial
The US Food and Drug Administration (FDA) says it is taking new steps to improve public access to clinical trial information.
The agency is launching a pilot program to evaluate whether releasing portions of clinical study reports (CSRs) will improve public access to drug approval information.
The FDA is also planning to add NCT numbers to FDA materials to make it easier to match listings on ClinicalTrials.gov to FDA communications.
FDA Commissioner Scott Gottlieb, MD, noted that, when a drug is approved, the FDA releases certain information the agency used when reviewing the new drug application (NDA).
This includes summaries written by medical reviewers that capture their assessment of the data, the proposed labeling or other requirements, and other data supporting safe and effective use. This information is included in the drug approvals database, Drugs@FDA.
Dr Gottlieb said these summaries 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.
Therefore, the agency is launching a pilot program to evaluate whether disclosing certain information included in CSRs will provide stakeholders with more details on the clinical evidence supporting a drug application and more transparency into the FDA’s decision-making process.
The FDA plans to select up to 9 recently approved NDAs whose sponsors will provide portions of CSRs from trials that were submitted to the FDA.
The CSRs 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.
The pilot will begin this month. The FDA will soon begin contacting sponsors to see if they are interested in participating in the pilot.
The agency will provide participating sponsors with additional information to ensure their understanding of the process. The FDA also promises to protect patient privacy, trade secret, and confidential commercial information in the CSRs it releases.
Once the pilot program is complete, the FDA will seek public feedback through a Federal Register notice and docket for public comments.
To augment the CSR pilot, the FDA is adding NCT numbers to materials for future drug approvals.
The agency believes this will make it easier to associate listings on ClinicalTrials.gov with FDA communications about specific drugs, including product labeling and advisory committee meeting materials.
