Feasible for Patients to Self-Report Adverse Events in Clinical Trials

Patients participating in cancer clinical trials were willing and able to report symptomatic adverse events and reported more events than investigators did.

Cancer patients participating in clinical trials were willing and able to report symptomatic adverse events and reported more events than investigators did, according to the results of a new study published in JAMA Oncology.

“This study demonstrates the feasibility of patient self-reporting of adverse events in multicenter cancer clinical trials, elucidates areas for further refinement, and paves the way for a more patient-centered and accurate approach to symptomatic adverse event reporting in cancer clinical research,” wrote researcher Ethan Basch, MD, MSc, of the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, and colleagues.

Traditionally, clinical investigators report adverse events during cancer clinical trials. However, there is increasing interest in collecting data on symptomatic adverse events from patients rather than from trial investigators. Prior to this study, it was unclear whether it would be feasible to implement a patient-reported outcome approach to adverse events in multicenter trials.

With this study, Basch and colleagues included 285 patients enrolled in one of nine multicenter cancer trials. Patients were invited to self-report 13 common symptomatic adverse events, using a patient-reported outcomes adaptation of the National Cancer Institute’s Common Terminology Criteria for Adverse Events, during five successive trial visits. Overall, there were 1,280 visits during which patients had an opportunity to self-report adverse events, and self-reports were completed at 1,202 visits (93.9% adherence).

Among the reasons for missing patient-reported outcomes was institution errors (56.3%) where, for example, staff forgot to bring computers to the patients to self-report during visits, patients feeling too ill (16.7%), patient refusal (16.7%), and internet connectivity issues (10.4%).

The study showed that patient-investigator agreement for adverse events was moderate or worse for most symptoms. The trial investigators reported fewer adverse events than were reported by the patients across all symptoms.

“Adverse events reported by patients but missed by clinicians reflect an area of the patient’s experience that may warrant particular attention in the future, both to alleviate patient discomfort and identify currently undocumented safety signals,” the researchers wrote. “Such focus may be particularly salient for targeted therapies and immunotherapies that cause long-standing, low-grade toxic effects.”

The patients reported that the system was easy to use (93.2%) and useful (93.1%), and investigators thought the patient-reported adverse events were useful (94.3%) and accurate (83.2%).

In an editorial that accompanied this research, Zaina P. Qureshi, PhD, MPH, MS, of the University of South Carolina, and colleagues, wrote: “An important consequence of the findings by Basch et al may be that patients may bridge the gap and be an important source of adverse event information in a wide range of clinical trials, facilitating more complete reporting of toxic effects during clinical trials.”