Editor’s note: After this story was published, we learned that we mistakenly counted some studies as violators of the reporting law because they were not included on a list of exempt studies provided to STAT by the National Institutes of Health. Before publication, NIH had described this list as a complete accounting of exempt trials. But an agency official subsequently told us that organizations running studies completed before Jan. 18, 2017 — when new ClinicalTrials.gov regulations went into effect — could delay reporting the results without seeking a formal exemption, if the drug being tested had not been approved by the Food and Drug Administration. For such studies, requesting a formal “certification for delay” was optional, the official said. Unfortunately, this means that for many older trials, there is no practical way for STAT or anyone else to verify which ones are exempt, but this story and the accompanying data visualization remain the most accurate assessment possible. Based on this new information, we have created a separate list of trials that sponsors say were unapproved and thus exempt, and have linked to any documentation provided by the sponsors. STAT has not verified these claims. Sponsors can submit information here. Thankfully, this transparency loophole has been partly fixed under the new rules, and for trials completed since Jan. 18, 2017, you can check this TrialsTracker website to determine whether the results are overdue. (The details of that site’s methodology are here.) You can also read a detailed description of the methodology STAT used to analyze the ClinicalTrials.gov database here.
The reporting of clinical trial results to a public database — mandated by a 10-year-old federal law — has improved sharply in the last two years, with universities and other nonprofit research centers leading the way, according to a new STAT analysis of government data.