Most of the reporting of adverse events in clinical trial is by doctors and other health professionals who are administering the treatment. However, there is an increasing effort in Europe and the US to include patient-reported data about adverse events as a source of information for optimising clinical trials.
Before this study it was not known if it is possible to implement patient-reported outcome measurements in a clinical trial. Ethan Basch and his team at the University of North Carolina say they have now proved the feasibility of this approach in a multicentre clinical trial.
Patients were asked to self-report 13 common symptomatic adverse events, using patient-reported outcomes adapted from the National Cancer Institute’s Common Terminology Criteria for Adverse Events, in five successive hospital visits.
Overall, there were 1,280 visits during which patients had an opportunity to self-report adverse events, with 93 per cent adhering to the self-reporting method. The majority of the patients said the reporting system was easy to use and useful for their treatment experience. Patient self-reporting was also endorsed by clinical investigators.
“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. Such focus may be particularly salient for targeted therapies and immunotherapies that cause long-standing, low-grade toxic effects”
An editorial that accompanied the research said, “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.”