Clinicaltrials.gov is Full of Errors About Study Timelines
(Thursday, August 11, 2022)
An independent review found many errors about the start and completion timelines for clinical trials reported on the clinicaltrials.gov registry. It also found that NIH and FDA have no mechanism to police the inaccuracies in the reported study timelines. The errors primarily emanate from the lack of standardization of the definition of the start and completion of a given trial. The initiation date for a clinical trial is generally accepted to be when the first patient for the study enrolls in the study by signing the informed consent. This excludes time needed to plan the study, site initiation activities, training, setting of the trial master file, shipping of investigational product to the site, and the pre-screening activities performed to identify potential participants for the study. There are several factors that may influence the enrollment of the first subject on a given clinical trial; it may several months or longer. There is significant variability in the study start date depending on how a reporter defines study start date. It is the study completion date, however, which is more critical, primarily because there is a regulatory requirement to report the results of the completed study on clinicaltrials.gov. A clinical trial is defined as completed by the NIH on the “the date that the final study participant was examined or received an intervention for the purpose of the final collection of data for the primary outcome.” It is distinct from the “study completion date,” which is when data on all primary and secondary outcomes, as well as any adverse effects, have been collected. While the last patient last visit date is objective, the “completion date” which includes all the activities needed for the data to be reported lends itself to be highly subjective. Data from the study cannot be analyzed till the data has been verified and “cleaned”, the data has been locked, and final supporting documentation for the cleaned study data have been completed, which could take significant time. The NIH definition for study completion date does not give credit to the researchers for the time to analyze data, write manuscripts and clinical study reports. However, most reporters of study results do not like to post results before all the above steps have been completed, leading to extensive delays in the reporting of results, leading to the kind of findings as reported. There is no easy solution to the problem as the publishers of the report found when interviewing NIH and FDA officials. For now, there is no motivation with the regulators to change the status quo, i.e., giving sponsors of clinical trials the flexibility to define study completion dates as they deem fit.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC