CLINICAL TRIALS TRANSPARENCY CAMPAIGN

 

Transparency is necessary in politics, but especially in healthcare, and in healthcare it could be a matter of life and death. A lack of reporting transparency results of clinical trial data can increase bias in studies (due to reduced data), slows down the rate of innovation of new medicines, and ultimately may lead to patient harm or death. UAEM students are urging their universities to register and report their clinical trials but also become the first academic institution worldwide to adopt the WHO Statement for Clinical Trials Transparency.

In May 2021 UAEM North America launched its latest report Clinical Trial Transparency at U.S. Universities: A New Report Measuring Legal Compliance with Clinical Trial Reporting Obligations in 2021 which studies clinical trial reporting data from the top 40 U.S. research institutions (both public and private). And, there is some encouraging news! We have been able to measure significant progress made by many leading universities in this area over the last two years due in part to advocacy by UAEM and our allies in this area. There are some repeat worst offenders however including: the University of Colorado, Denver, University of Washington, New York University Langone Health, University of Cincinnati, and Stanford University. 

Successes highlighted in the report include:

  • the increase in number of research institutions legally compliant under FDAAA (100% of clinical trials reported)  from 13 to 17, 
  • the increase in total number of registered clinical trials from 446 to 1516 between February 2019 and February 2021,
  • The decrease in total number of unreported trials from 138 to 101. 

The findings of the report and microsite https://altreroute.com/clinicaltrials/ were covered in STAT NEWS among other news outlets. To read the full report and findings, click here

 

Open Letter to the FDA Commissioner - The Hon. Robert M. Califf

On April 21, 2022, UAEM sent an open letter to Robert M. Califf, the newly appointed U.S. Food and Drug Administration (FDA) Commissioner calling his leadership to attend with real urgency to the significant but so far underserved issue of clinical trial registration and results reporting. Read the full letter below: