The FDA has launched a new pilot program that will evaluate whether disclosing certain information within clinical study reports following approval of a new drug application enhances public access to drug approval information, according to a statement by FDA Commissioner Scott Gottlieb, MD. The agency is also working to add a trial's ClinicalTrials.gov identifier number to the agency’s materials for future drug approvals.
The FDA is taking new steps to boost transparency of clinical trial information as they aim to promote innovation and scientific inquiry related to new drugs, according to a statement from FDA Commissioner Scott Gottlieb, MD.
“Scientific progress and new drug innovation don’t take place in a vacuum,” wrote Gottlieb. “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.”
According to Gottlieb, transparency related to this information can have a crucial role in optimizing the public health value of the resulting innovations. With this in mind, the FDA has launched a new pilot program that will evaluate whether disclosing certain information within clinical study reports (CSRs) following approval of a new drug application (NDA) enhances public access to drug approval information. A CSR is a portion of a drug file, related to a clinical trial, that includes summaries of the bottom-line information on the methods and results of a clinical trial.
The pilot program will select 9 recently approved NDAs whose sponsors volunteer to provide portions of clinical trial-related summaries from pivotal trials that were submitted to the FDA. The agency will set its focus on posting the portions of the CSRs that provided the most insight to the safety and efficacy of the drug. It will include the student body report, the protocol and amendments, and the statistical analysis plan for each of the studies.
Currently, when a drug is approved, the FDA provides certain information that it used while assessing the NDA. This information includes summaries written by the agency’s medical reviewers on their assessment of the data, the proposed labeling or other requirement, as well as other relevant data supporting safe and effective use.
“These summaries provide important context on the basis for our approval decisions,” wrote Gottlieb. “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.”
The intent of making the CSRs publicly available following a drug’s approval is to provide stakeholders with more information on the clinical evidence supporting a drug application and greater transparency into the FDA’s decision-making process.
“When we’re able to link to CSRs, it’ll make development of the review document more accessible," said Gottlieb during a symposium hosted Wednesday by Johns Hopkins Bloomberg School of Public Health. "We are trying to come up with a more consolidated review memo; 1 document where you can see the consensus and disagreement all in 1 place, released at the time of the drug approval. This will allow third parties to run more analytics around our decision-making, and have research better informed by actual data.”
The FDA is also working to add a trial's ClinicalTrials.gov identifier number to the agency’s materials for future FDA drug approvals. By providing the number, it will make it easier to associate the clinical trial listings on ClinicalTrials.gov with FDA communications about specific drugs, wrote Gottlieb. These communications include product labeling and advisory committee meeting materials.
“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,” concluded Gottlieb.