The International Society for Pharmaceutical Engineering (ISPE) released its first report on its project concerning patient experiences with clinical trial materials, ISPE announced in a press release. The survey collected data related to patients’ current and recent experiences, attitudes, and perceptions; suggestions for improvements; and demographic information. The report, released at the 2013 ISPE Annual Meeting, details the results of the survey, which measured the experiences of 1425 respondents in the industry’s first large-scale effort to collect data of this kind from patients engaged in clinical trials.
The survey found that patients are invested in compliance with study protocols when they understand what they are and the underlying rationale for the requirements. It is important 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, commented ISPE in the release. In the survey, patients indicated a variety of ways in which “one size fits all” is not optimal from the patient perspective. The study strongly suggests that 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, concluded the ISPE Patient Survey Project Team. The survey also showed a clear need for improving the clinical trial medicine return process.
The ISPE Patient Survey Project Team will continue to review and analyze the survey data. The team currently plans to present additional findings throughout 2014 and to engage both industry leaders and regulators in a series of discussions to plan follow-up projects.