Data from potentially “hundreds” of clinical trials conducted between 2007 and 2017 for products approved by the US Food and Drug Administration (FDA) could be posted on ClinicalTrials.gov as a result of a recent ruling from a federal judge.
The lawsuit was brought forth on December 7, 2018, by Charles Seife, professor of journalism at New York University, and Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest.1
Judge Naomi Reice Buchwald of the Southern District of New York ruled on February 24, 2020, that the FDA, National Institutes of Health (NIH), and Department of Health and Human Services (HHS) have “misinterpreted” the FDA Amendments Act (FDAAA) of 2007, as stated in a press release.1
FDAAA requires clinical trial sponsors to post basic summary results from select trials on ClinicalTrials.gov. The law does not apply to every clinical trial, only select trials that meet the criteria known as “applicable clinical trials.” These trials are generally phase 2 or later-phase trials, were initiated after September 2007, have at least 1 trial site in the United States, and are evaluating a drug, device, or biological agent. The law also requires trial sponsors to report these basic results within 1 year of trial completion.
Although FDAAA was passed in 2007, the final rule was not released until September 2016, with an effective date of January 18, 2017. Also, the final rule deviated from FDAAA, exempting trials that were completed before January 18, 2017 and that assessed products that were later approved by the agency. This exemption was the central issue of the lawsuit.2
“The issue here is not the results reporting for all clinical trials,” Dr Lurie told Cancer Therapy Advisor. “It’s the results reporting for a fairly narrow subset of them.”
Examples of trials that the lawsuit applies to include a randomized trial sponsored by Eisai Inc. that evaluated decitabine in children with acute myelogenous leukemia (ClinicalTrials.gov Identifier: NCT01177540) and a trial sponsored by NewLink Genetics Corporation that evaluated CRLX101 in combination with bevacizumab in patients with metastatic renal cell carcinoma (ClinicalTrials.gov Identifier: NCT02187302). In addition, 2 separate trials sponsored by UCSF Benioff Children’s Hospital Oakland, California, in collaboration with Genentech, Inc., are also listed as examples of trials that have yet to report results (ClinicalTrials.gov Identifier: NCT01556009; ClinicalTrials.gov Identifier: NCT00957229).2
Although posted in 2019, the results of the randomized phase 3 trial sponsored by Taiho Oncology, Inc. that led to the FDA approval of TAS-102 for patients with metastatic colorectal cancer (ClinicalTrials.gov Identifier: NCT01607957) were not posted within the 1-year allotted time frame, making this pivotal trial another example of a noncompliant trial.2,3