The International Society for Pharmaceutical Engineering (ISPE) released the first report from its project on patient experiences with clinical trial materials, detailing results of the Society’s patient survey, which measured the experiences of 1,425 respondents in the industry’s first large-scale effort to collect data of this kind from patients engaged in clinical trials.
The survey collected patients’ current and recent experiences, attitudes and perceptions, suggestions for improvements and demographic information. Among the survey’s key findings: patients want to comply with clinical trial instructions and they want studies to succeed; customization and accommodation of individual differences is essential; and there is a clear need for improving the clinical trial medicine return process.
Evidence suggests patients are invested in compliance with study protocols when they understand what they are and the underlying rationale for the requirements. It is important for professionals to explore ways to increase patient understanding of the clinical trial process and to make compliance easier within the confines of a scientifically sound study design.
Patients have indicated a variety of ways in which “one size fits all” is not optimal from the patient perspective. The study strongly suggests professionals will need to consider how to accommodate patients’ differing needs and preferences within the confines of a study protocol. To the extent this can be done, patient compliance may go up.
Patients often don’t know that medication returns are necessary and, when they do know, there sometimes is an incentive to keep the medicine rather than return it. Professionals need to give considerable thought to new ways to help patients understand and buy into this process.