ISPE Patient Initiative Releases Report on Patient Experience with Clinical Trial Materials

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ISPE released the first report on its project concerning patient experiences with clinical trial materials. The report details the 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 report was released at the 2013 ISPE Annual Meeting, during an executive session on ISPE Research Initiatives, and it was made possible through the underwriting support of eleven companies engaged in studies involving IMPs.

The survey collected a robust set of data related to patients’ current and recent experiences, attitudes and perceptions, suggestions for improvements and demographic information. Among the survey’s key findings were:

  • Patients want to comply with clinical trial instructions and they want studies to succeed. Evidence suggests 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, then, for IMP professionals and their colleagues 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.
  • Customization and accommodation of individual differences is essential. Patients have 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.
  • There is a clear need for improving the clinical trial medicine return process. Patients often don’t know that returns are necessary, and when they do know it there is sometimes an incentive to keep the medicine rather than return it. IMP professionals and their colleagues need to give considerable thought to new ways to help patients understand and buy into this process.

The ISPE Patient Survey Project Team will continue to review and analyze the survey data in the coming months. 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. These “phase II” investigations will expand on the current data set and further investigate the themes above—as well as others which may yet be revealed.

The full report can be downloaded at ( 1 MB).

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