Court Ruling on clinical data not posted on CT.gov
We gladly receive and publish the article by Robert Paarlberg on the recent ruling which envisages a new interpretation regarding the publication obligations of clinical trials prior to 2017 on ClinicalTrials.gov.
On February 24th a New York federal judge ruled on a case related to the FDAAA Final Rule stating that FDA and the NIH have for years misinterpreted the Final Rule that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on ClinicalTrials.gov.
The case was brought by former associate FDA commissioner Peter Lurie and New York University journalist Charles Seife. Peter Lurie wrote an article in Stat News June 4, 2019 titled “Hiding in plain sight: The FDA’s approach to disclosing new drug applications is a disservice to public health”. He is currently President of the Center for Science in the Public Interest, a non-profit watchdog organization.
The Final Rule (42 C.F.R. § 11) limited requirements for providing basic results of Applicable Clinical Trials (ACTs) that completed before the rule’s enactment on January 18, 2017. Under the Final Rule, results for those trials were only required if the product was approved (or the device cleared) for any use before the trial’s completion date.
However, under the original FDAAA 801 rule, it was generally understood that results for ACTs were required within 12 months of the completion date or 30 days after the product approval, whichever came later, irrespective of whether the product was approved before or after the trial completion date. If this ruling stands, it reinstates this requirement that results must be posted for all pre-Final Rule ACTs within 12 months of completion or 30 days after approval (whether the approval came before or after the trial’s completion date).
It is not clear how this ruling will be enforced. The Court ruling could still be challenged by the FDA and NIH lawyers.
The ruling might ‘prompt’ FDA to finalize their draft guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (September 2018)”.
Below are articles on this ruling:
- Clinical Trial Sponsors Have to Disclose Decade’s Worth of Unreleased Data, Federal Judge Rules, Endpoints News, February 26, 2020
- Transparency Advocates Win Victory for Public Access to Clinical Trial Data, Yale Law School, February 25, 2020
- Federal Judge Rules Clinical Trial Sponsors Must Publish a Decade’s Worth of Missing Data, STAT News, February 25, 2020
