Responsible Parties—Is It Time to Clean Up Your ACTs?

Abstract

This brief study examined applicable clinical trials (ACTs) registered in the ClinicalTrials.gov website that may be considered by the Food and Drug Administration to be noncompliant and subject to enforcement penalties after the Food and Drug Administration Amendments Act of 2007 rulemaking, anticipated in 2014. Prior literature verifies the existence of ACT recordkeeping issues. The results of this simple analysis are valuable with providing baselines for the tracking of record maintenance trends because no documented prior analyses could be located. Ascertaining which registered studies meet the criteria of an ACT is quite difficult because there is no element in each ClinicalTrials.gov record specifically indicating as much. Neither is there an element in each record indicating whether trial sponsors have received an extension from the National Institutes of Health (NIH) to delay reporting study results that exceed the regulatory mandated timeline of 12 months after the “primary completion date” element. Therefore, studies that meet the fundamental criteria for being an ACT were extracted through the ClinicalTrials.gov database advanced search function. The extracted records were downloaded to an Excel spreadsheet to filter for the intervention types of biologics, devices, and drugs. Advanced search filtering procedures yielded 39,564 records. From this pool of “potential ACT” records, 2 noncompliance issues were extracted: first, studies that had not been updated in 2 years and were marked by the NIH as “unknown”; second, studies that were marked by the responsible party as “completed” or “terminated” but did not have any results posted 12 months after the primary completion date. This resulted in a total of 13,060 (33%) potential ACT records identified as being at risk for having noncompliance issues. The idea behind this article was substantiated—that maintenance of ACT records in the ClinicalTrials.gov database needs to improve. Responsible parties are urged to avoid FDA issued noncompliance penalties, by ensuring that all their ACT records are updated and regulatory compliant prior to the rulemaking that is on the agenda for 2014. Sponsors can accomplish this by developing standard operating procedures that facilitate proper study registration, routine updates of ongoing ACT records, and timely posting of study results. Using regulatory requirements and NIH guidelines, ideas are provided for improving recordkeeping practices, data disclosure timeliness, and the structure of the records found in ClinicalTrials.gov.