Majority of radiotherapy trials remain unpublished
medwireNews: Compliance with the mandatory requirement in the USA to publish the results of clinical trials is poor, shows research presented at the 35th ESTRO conference held in Turin, Italy.
Jaime Pérez-Alija and Pedro Gallego, from Hospital Plató in Barcelona, Spain, identified 655 interventional phase III trials in radiotherapy with a primary completion date of 1 January 2013 in the ClinicalTrials.gov database. Of these, 81.7% had not made a summary result publicly available despite the US FDA Amendments Act of 2007, which requires results to be deposited within 12 months of the initial completion date.
Restricting their analysis to trials that began after 2007 did not improve the picture substantially – 76.4% of 422 trials lacked any published findings.
Trials in testicular and anal cancer had the poorest compliance, with 100% of trials remaining unpublished, while eye cancer trials had the best adherence, with published results for more than half (53%).
The authors think that one reason for noncompliance could be that trials have received a deadline extension, but if so, these were not documented in the database.
"We have shown that a large number of study participants are routinely exposed to the risks of trial participation without the benefits that sharing and publishing results would have for patients in the future”, they said in a press release.
“This ethical issue should be at the heart of our current medical practice, and our leaders should be made aware that withholding these data poses a significant threat to public health.”
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