MANDATORY REGISTRY OF CLINICAL TRIALS

To advocate disclosure of the most complete information on the safety and efficacy of drug products; further,

To advocate that the Department of Health and Human Services establish a mandatory registry for all Phase II, III, and IV clinical trials that are conducted on drugs intended for use in the United States; further,

To advocate that each clinical trial have a unique identifier; further,

To advocate that all data from registered clinical trials be posted electronically with unrestricted access, and that such posting occur (1) after Food and Drug Administration approval of the related new product but before marketing begins and (2) as soon as possible for trials completed after initial marketing.

This policy was reviewed in 2023 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.

Rationale

Incomplete disclosure of data on the safety and efficacy of drug products from clinical trials has negatively impacted patient safety and pharmacy practice. For example, in 2004 unpublished data and results regarding the efficacy and safety of antidepressants in pediatric patients prompted a national analysis of the potential effects of suppressing negative findings in clinical trials. That experience demonstrated that positive and negative data and results should be made available to healthcare providers so they can make the best decisions about medications for their patients.

In 2016, the Department of Health and Human Services issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The rule expands the legal requirements for submitting registration and results information for clinical trials involving U.S. Food and Drug Administration-regulated drug, biological and device products. Similarly, the National Institutes of Health has issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule. Requirements under the final rule apply to most interventional studies of drug, biological, and device products that are regulated by the FDA.