About the 2013 Patient Survey

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ISPE sees in the future the supply of clinical materials becoming a two-way street, with information flowing upstream from the patients and sites to drive the downstream flow of user focused products and services. This first patient survey is a small but important step.

Beginning in Q2 2013 the ISPE Patient Survey Project Team will survey no fewer than 2000 clinical trial patients globally to gain their feedback on the suitability of clinical materials that are currently provided and to obtain the patients’ suggestions for improvements. The goals of the Project are:

  1. Understanding of patient experience with Investigational Products, which will support informed decisions, related to future study materials, resulting in improved patient compliance as well as more efficient and effective studies.
  2. Understanding of the impact of key patient differentiators (demographics such as age, global location, study type, etc) on patient experience, which will allow clinical and clinical supply teams to determine when adjustments are needed to ensure protocol compliance.
  3. Providing a data set that impacts decisions, opens new areas of inquiry, and generates practice implications for both good manufacturing practices (cGMPs) and the GCP-GMP interface.
  4. Increasing collaboration between global regulatory bodies, companies engaged in the IMP sector, and facilitator organizations like ISPE so that enlightened global Guidance(s) result.

Check the July-August issue of Pharmaceutical Engineering Magazine for a full length article about the survey design.

Indicates content available to ISPE members only.


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