Some data on trials for FDA-approved cancer drugs ‘unavailable to independent scrutiny’
Click Here to Manage Email Alerts
Key takeaways:
- More than half of analyzed trials for FDA-approved cancer therapies were ineligible for individual patient data sharing.
- Fewer than 10% of trials that assessed nivolumab, pembrolizumab or pomalidomide were eligible.
- Transparency policies must be updated so all individual patient data that "inform results presented in a product label or underpin drug registration" are eligible for sharing, investigators wrote.
Although efforts have been made to increase sharing of individual participant data from clinical trials, data from many oncology clinical trials that support FDA approval of anticancer therapies remain unavailable to researchers.
The findings, published in JAMA Oncology, suggest data accessibility could be improved if all data that support the FDA registration of treatment became available at the time of FDA approval, researchers noted.
Rationale and methods
When individuals commit to participate in clinical trials, they are advised and reasonably expect that although they may not personally benefit from their participation, the knowledge gained will contribute to better care for future patients, Ashley M. Hopkins, PhD, senior research fellow at Flinders University College of Medicine and Public Health, Australia, told Healio.
“In 2014, the pharmaceutical industry, via the Pharmaceutical Research and Manufacturers of America [PhRMA] and the European Federation of Pharmaceutical Industries and Associations [EFPIA], acknowledged the importance of individual participant data sharing as a means to honor the commitment of trial participants,” he said. “Subsequently, emerging policies released by many pharmaceutical companies outlined their individual commitments to transparently sharing clinical trial data. These data offer an unparalleled opportunity to advance evidence-based medicine, support decision making and ensure independent scrutiny.”
Hopkins and colleagues sought to evaluate the eligibility of independent qualified researchers to access individual participant data from oncology trials that supported FDA approval of novel anticancer therapies. They performed a cross-sectional analysis of pivotal clinical trials whose results, identified from product labels, supported anticancer therapy approvals between Jan. 1, 2011, and June 30, 2021.
The frequency of individual participant data sharing eligibility served as the primary outcome.
Key findings
Researchers identified 115 anticancer therapies the FDA approved based on findings of 304 pharmaceutical industry-sponsored trials. Of these, 136 trials (45%) were eligible for individual participant data sharing and 168 trials (55%) were not.
They additionally found substantial differentiation in data sharing rates among industry sponsors, with more than half (53%) reporting ongoing collection of long-term follow-up data as the most common reason for not sharing individual participant data.
Of note, the lowest eligibility rates for data sharing among the top 10 anticancer medicines by global sales included trials of nivolumab (Opdivo, Bristol Myers Squibb), pembrolizumab (Keytruda, Merck) and pomalidomide (Pomalyst, Celgene).
Implications
“Since these trials form the basis of these newer medicines’ safety and efficacy claims, we question whether it is justified that the data is unavailable to independent scrutiny,” Hopkins told Healio. “The present study’s findings reiterate calls that transparency policies need updating so that all individual participant data informing results presented in a product label or underpinning drug registration are immediately eligible for sharing.”
For more information:
Ashley M. Hopkins, PhD, can be reached at ashley.hopkins@flinders.edu.au.
Collapse
Read more about
Click Here to Manage Email Alerts