On February 24, 2020, the Court ruled in favor of Mr Seife and Dr Lurie, concluding that FDAAA “unambiguously” requires ClinicalTrials.gov to include basic results for applicable clinical trials completed before January 18, 2017, and that assessed a product that the FDA approved after trial completion.4

“The Court has now ruled that, indeed, those trials are required to report their results,” said one of the lawyers on the case Christopher Morton, supervising attorney at the Technology Law and Policy Clinic at NYU Law, during an interview with Cancer Therapy Advisor. “That is now the law.”

Michael Sinha, MD, JD, MPH, research fellow in therapeutic science, Harvard-MIT Center for Regulatory Science and Program On Regulation, Therapeutics, And Law (PORTAL), Harvard Medical School, told this publication that it is “incredibly important” that these trial data be reported.

“Often, [results from] trials are not published in a timely manner, and data summaries often leave out important information necessary to validate results from clinical trials,” he said. “Making data available on ClinicalTrials.gov will provide an incentive for earlier publication of clinical trial results while allowing interested researchers the opportunity to access unbiased data and conduct additional statistical analyses.”

However, although studies have repeatedly shown that trial sponsors are often not compliant with reporting basic results on time, requiring sponsors to post data from clinical trials in general — not just those for which this ruling applies — may not be a simple ask.5,6

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“Part of the reason there was a delay [in the finalized rule] was that it’s not clear how to do this,” Jason Luke, MD, director of the Cancer Immunotherapeutics Center within the UPMC Hillman Cancer Immunology and Immunotherapy Program in Pennsylvania said during an interview with Cancer Therapy Advisor. Dr Luke has many industry relationships, having consulted for, and received research support from, several pharmaceutical companies.

Now that trial sponsors will be “forced” to post these data, his guess is that it will be “rather haphazard” at first.  He explained that the reporting requirements for clinical trial results are already not very feasible for sponsors, and that the ruling is going to make the reporting of results even less practical.

The lawsuit also included a second claim, which attempted to hold the NIH responsible for its failure to post public noncompliance notices for trial results and to create a search function for such notices. However, that particular claim was dismissed.4

“We are still considering our options at this moment,” Morton said.

Disclosure: Dr Luke has consulted for Eisai and received research funding from Genentech.

References

  1. Yale Law School. Transparency advocates win victory for public access to clinical trial data [news release]. New Haven, CT. Published online February 25, 2020. Accessed March 6, 2020.
  2. Charles Seife and Peter Lurie vs US Department of Health and Human Services, Alex M. Azar II, Secretary of Health and Human Services, in his official capacity; National Institutes of Health; Francis S. Collins, Director of the National Institutes of Health, in his official capacity; U.S. Food and Drug Administration; and Scott Gottlieb, Commissioner of Food and Drugs, in his official capacity. Case 1:18-cv-11462. Filed December 7, 2018. https://law.yale.edu/sites/default/files/area/center/crit/document/seife_lurie_v._u.s._department_of_health_and_human_services_et_al._1._complaint.pdf. Accessed March 6, 2020.
  3. Marcus L, Lemery SJ, Khasar S, et al. FDA approval summary: TAS-102. Clin Cancer Res. 2017;23(12):2924-2927.
  4. Naomi Reice Buchwald, United States District Judge. Case 1:18-cv-11462-NRB. Filed February 24, 2020. Accessed March 6, 2020. https://law.yale.edu/sites/default/files/area/center/crit/document/65._order_on_sj1.pdf
  5. Prayle AP, Hurley MN, and Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373.
  6. Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, and Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015;372:1031-1039.