Physician-Reported Experience and Understanding of Adverse Event Attribution in Cancer Clinical Trials

Abstract

Objectives: To report the results of a survey conducted among Mayo Clinic medical oncologists, hematologists, and cancer prevention specialists to better understand the current practice of determining whether an adverse event that a patient experience in a clinical trial is related to the drug under investigation, a process commonly known as attribution, as well as to formulate recommendations for an improved system. Patients and Methods: An electronic survey was developed and conducted (from August 2 through 29, 2017) among 165 medical oncologists, hematologists, and cancer prevention specialists at the 3 Mayo Clinic sites: Rochester, Minnesota; Scottsdale, Arizona; and Jacksonville, Florida. The survey included 21 items that queried clinicians about their clinical practice and trial experience, their training and process in adverse event attribution assignment, and their recommendations for improving the current attribution system. Results: Thirty-seven percent (61 of 165) of physicians responded to the survey. The median number of years in clinical practice was 15 (range, 1-64) and that of clinical trial experience 12. Eighty-nine percent (54 of 61) had served as a trial principal investigator. Only 15% (9 of 60) of responders reported having received any formal attribution training. Eighty percent (48 of 60) were confident about their ability to assign attribution. Seventy-five percent (45 of 60) consulted their colleagues or study chair when assigning attribution. Sixty-seven percent (40 of 60) recommended formal training to improve attribution accuracy. Conclusion: 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. These data underscore an unmet need of formal adverse event attribution training among clinical trialists.