Sponsors of pancreatic cancer trials are violating the requirement to publish results within 1 year of trial completion, according to research published in The Oncologist.
Researchers found that 30% of pancreatic adenocarcinoma (PDAC) trials completed from 2010 through 2020 did not have results published on ClinicalTrials.gov or as full-text articles in journals.
Furthermore, only 8% of eligible trials had results available within 1 year of trial completion, in compliance with the 2007 US Food and Drug Administration Amendments Act (FDAAA) 801 and its 2017 final rule.
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Researchers conducted this study by searching the ClinicalTrials.gov registry for trials of PDAC management in adults. Included trials were completed or terminated, with primary completion dates from January 1, 2010, through June 1, 2020.
The primary outcome of this study was the proportion of trials that had results available through the ClinicalTrials.gov registry, publication in a full-text article, or both.
The researchers identified 551 trials that included a total of 36,436 patients. Overall, 17% of patients (n=6273) were in trials that did not have results available.
Seventy percent of trials (n=386) did have results available. Results from 182 trials were published in a full-text article only, results from 89 trials were published in the registry only, and 115 trials had results published both in full-text articles and in the registry.
At 12 months from the primary completion date, the cumulative percentage of trials with results available was 21%. That percentage increased to 44% by 24 months and 57% by 36 months.
FDAAA 801 and the final rule applied to 218 of the trials (40%), but only 8% of these trials had results posted within 1 year of trial completion.
Still, trials were more likely to have results available if they were required to comply with FDAAA 801 and the final rule. These trials had a hazard ratio (HR) of 2.13 for the availability of results (95% CI, 1.73-2.63; P <.001).
Factors associated with a lower likelihood of results being available included a trial being terminated rather than completed (HR, 0.51; 95% CI, 0.39-0.67; P <.001), having industry funding (HR, 0.73; 95% CI, 0.59-0.91; P =.005), and having a small enrollment sample size (per 10 patients: HR, 1.02; 95% CI, 1.01-1.03; P =.003).
“Availability of results is a crucial step to prevent the risk of biased literature, which can negatively impact future meta-analyses results and the development of therapeutic guidelines,” the researchers wrote. “Also, not publishing trial results raises an ethical issue for patients who agree to participate in these trials.”
“It is crucial to help improve the availability of results for future trials in patients with PDAC since it will become an important public health issue. New ways to improve results availability are urgently awaited.”
Reference
Pellat A, Boutron I, Ravaud P. Availability of results of trials studying pancreatic adenocarcinoma over the past 10 years. Oncologist. Published online August 19, 2022. doi:10.1093/oncolo/oyac156
