Unite for Clinical Trials Transparency
Posted on 21st December 2023 by Hanna Wu
A call to health justice organizations to submit comments to the Universities Allied for Essential Medicines (UAEM) citizen petition
By now, if you’ve been following the clinical trial transparency campaign, you know that transparency and accountability are critical for the advancement of healthcare and medical research. We’ve seen this reflected in the $7 billion in tax-payer dollars allocated for “clinical trials and supportive activities” funding, underscoring the importance of these initiatives. But even more poignantly, we’ve seen this in how patients and families consistently depend on up-to-date accurate information about clinical trials to make informed health decisions or how physicians need access to essential health information to provide their patients with the best care possible.
Reporting clinical trial results goes hand-in-hand with the right to transparency that taxpayers demand from drug producers and the right to health information that patients demand from the U.S. Food and Drug Administration (FDA). To this end, physicians, researchers, and the public rely on updated results reporting to make informed health and safety decisions.
Yet, over 4,000 clinical trial results remain missing from the federal database Clinicaltrials.gov. This not only jeopardizes patient health and safety but also undermines the integrity of the entire healthcare system.
In February of this year, the UAEM North America Clinical Trials Transparency team took a significant step forward by filing a formal FDA citizen petition with recommendations to increase enforcement of clinical trial results reporting law. While the FDA was federally required to respond by August 26th 2023, the agency issued a non-substantive response only two days prior citing it “will require additional time to issue its final response to [the] petition…”
Why Act Now?
Timeliness is of the essence in this issue. The FDA’s non-substantive response means that it has granted itself an indefinite amount of time to fix these problems, while patients continue to endure the adverse consequences of their laxity.
Therefore, we invite you to play an active role in this crucial endeavor. We hope your organization will join UAEM by urging the FDA to prioritize timely results reporting.
How to Extend Your Support:
We kindly request your organization’s involvement in submitting a letter of support for the petition to the FDA. As a health justice organization, your endorsement adds significant weight to this rally. Letters of support often range from a paragraph to a page in length; you can find examples here from Walter Willett from the Harvard School of Public Health and David Jenkins from the University of Toronto.
Although we are not permitted to write letters on behalf of allied groups, we have put together a set of talking points with submission instructions that we hope will make this simpler. If there are any other materials we can provide or any questions we can answer, do not hesitate to let us know. We appreciate your support in defending patient access to essential health information!
This article was original published on Universities Allied for Essential Medicines (UAEM).
You may also be interested in the following articles via TranspariMED:
FDA excuses failure to enforce key transparency law: ‘It’s too complex’
Congressman slams FDA over failure to tackle missing clinical trial results
