For the first time, the FDA has issued a noncompliance to a trial sponsor for clinicaltrials.gov requirements. Transparency in clinical trial results is crucial for the development of therapies and the safety of participants. This is especially true for oncology clinical trials and the cancer patients who enroll. Trial results, transparency, and the other aspects of compliance are monitored by the Food and Drug Administration (FDA) and explicitly laid out on their website.
In April of 2021, the first noncompliance was issued by the FDA to Acceleron Pharmaceuticals, Inc. After the notice was given, Acceleron had 30 days to submit the required information. Because of the noncompliance, the FDA can seek civil money penalties and if the information is not submitted within 30 days, additional penalties can be given. The noncompliance was issued due to a failure to submit the required summary results information on clinicaltrials.gov. Although this is the first, there have been over 40 pre-notices of noncompliance sent to encourage voluntary compliance with all requirements.
FDA Clinicaltrials.gov Requirements for Oncology Clinical Trials
When the FDA issued its first noncompliance for clinical trial requirements, it shows the FDA takes trial registration and results very seriously. By enforcing these rules, the FDA is helping benefit clinical trial participants, and future clinical trials. Clinical Trials are important for the development of new therapies and drugs in cancer. Without them, there would not be nearly as much improvement and innovation for treatments that we see today. Recently, many targeted therapies and immunotherapies have been developed through oncology clinical trials. Targeted therapy locates specific biomarkers within cells and attack them, which helps avoid healthy cells to reduce side effects. Immunotherapy helps activate the body’s immune system to kill the cancer cells. The approach the FDA takes to determine whether trial sponsors are complying with all legal requirements when submitting trial information to Clinicaltrials.gov.
These clinical trials are the only way for the FDA to approve new studies for commercial use. Without the approval, they can only be used within clinical trials that are monitored by the FDA. These clinical trials take several years and four phases before being eligible for approval. Because of this, it is crucial for the safety of the trial for all participants to follow the requirements from the FDA. Acceleron’s noncompliance has been posted to the FDA’s website and further information will be posted on the study’s record on ClinicalTrials.gov by NIH.