Clinical Trial Registries Show Many Mistakes
A review of 10,492 clinical trials that are registered on both the United States government’s ClinicalTrials.gov registry and the European Union’s Clinical Trials Register (EUCTR) found that 16.2 percent had differing statuses on the two sites, and 33.9 percent of trials shown as “completed” on ClinicalTrials.gov were only “ongoing” on EUCTR, reported Melissa Fassbender in OutsourcingPharma.com.
The study was led by Dr. Ben Goldacre of University of Oxford DataLab, along with Jessica Fleminger, a graduate-entry medical student at Worcester College, Oxford, and is currently working on the Open Trials International project with the EBM DataLab team. According to Goldacre, “We work a lot with trial registry data, and often find it to be inaccurate. We found that the completion status is very commonly wrong, and that the errors seem to be on the EU trial register. I expected errors, but I was very surprised by the scale of the errors. As with all issues around trials transparency, wherever there are problems like those documented, it undermines trust in industry, and in medicine more broadly. Trialists should ensure their registry data is correct. Registry owners should run basic checks to assess whether the data they hold is discrepant. There is no reason for trials to be unreported, nor for trial registry data to be inaccurate.”
The FDAAA TrialsTracker, which provides a public list of all trials required to report under the FDA Amendments Act of 2007 (FDAAA), updates every weekday with live data showing who has reported results to comply with the law. One recent unreported trial was sponsored by the FDA, the agency in charge of enforcing the reporting requirements of the FDAAA. Goldacre and Fleminger called it to the FDA’s attention, prompting Ed Silverman, writer for Pharmalot at STAT, to contact the FDA.
According to an FDA spokesman quoted in the article, “Upon our review of the available information for NCT02821338, we determined that this study was mistakenly registered as a Phase 4 trial, when in fact this type of bioequivalence study is considered to be a Phase 1 trial, and therefore not an applicable clinical trial (ACT) to which the ClinicalTrials.gov requirements apply (see 81 FR 65016). Although this study is not an ACT and is not required by law to be registered or have results information submitted, for purposes of transparency, the FDA intends to submit the results of the study as soon as they are available. The CT.gov record will be updated accordingly.”
Physicians and researchers look to “completion” status as a sign of whether a trial was conclusive and had reportable results. In a paper, “FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results, Goldacre, Nicholas J. DeVito and Seb Bacon, said, “ Clinical trials continue to go unreported despite numerous guidelines, commitments and legal frameworks intended to address this issue. In the absence of formal sanctions from the FDA and others, we argue tools such as ours -- providing live data on trial reporting -- can improve accountability and performance. In addition, our service helps sponsors identify their own individual trials that have not yet reported results: we therefore offer positive practical support for sponsors who wish to ensure that all their completed trials have reported.”