Formal training for adverse event attribution was uncommon among cancer clinical trialists, a survey revealed, underscoring the need for such training. The survey results were recently published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes.
Attribution can be defined as the practice of defining whether an adverse event that a clinical trial participant experiences is related to the drug being evaluated. To better understand the current practice of adverse event attribution, study researchers conducted a 21-item survey. A survey link was sent via email to 165 medical oncologists, hematologists, and cancer prevention specialists across 3 Mayo Clinic sites, and 61 professionals (37%) responded to the survey; 1 recipient responded but did not complete all the questions.
All survey respondents had enrolled in and/or assessed patients in at least 1 clinical trial. Responders had a median of 12 years of clinical trial experience (range, 2-45 years), and most (89%) had been a principal investigator on at least 1 clinical trial; more than half of survey participants had helped conduct a minimum of 10 clinical trials.
The survey revealed that 15% of survey respondents had received some type of formal attribution training and 70% had received some informal training. Most (80%) reported being “very” or “somewhat” confident about their ability to designate an adverse event as related to treatment, and 92% reported having second thoughts at some time about their own how they attributed adverse events. Clinical colleagues (75%) and the study principal investigator (73%) were the team members most often consulted for adverse event attribution input. Two-thirds of respondents suggested that formal training was an effective approach to learn how to properly characterize the reasons why adverse events appear.
“Very few clinical trialists in our survey received any formal training for adverse event attribution, yet most identified formal training as effective means to improve attribution accuracy,” the study authors wrote. “These data underscore an unmet need of formal adverse event attribution training among clinical trialists.”
Le-Rademacher JG, Storrick EM, Jatoi A, and Mandrekar SJ. Physician-reported experience and understanding of adverse event attribution in cancer clinical trials. Mayo Clin Proc Innov Qual Outcomes. 2019;3(2):176-182.