By Clinical Research News Staff

January 14, 2020 | Two years ago the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) enacted a “final rule” clarifying how and when companies, universities, and other institutions that conduct clinical trials must record their results in a federal database, and what were the penalties for failing to disclose trial results. A Science investigation released this week shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines.

Deborah Zarin, a physician at Brigham and Women’s Hospital and Harvard who headed ClinicalTrials.gov between 2005 and 2018, says the Science findings show failures of the research culture, FDA, and NIH. The problem persists, she told Science, because “reporting to ClinicalTrials.gov is frequently seen by sponsors, funders, and trialists as an annoying administrative and perhaps legal burden, not a scientific imperative. Human nature being what it is, people follow the requirements when forced to do so.”

Read the full report and see the listings of institutions at Science.