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ISPE Patient Initiative Issues Survey Regarding Patient Experience with Clinical Materials
Date:6/10/2013

TAMPA, Fla., June 10, 2013 /PRNewswire-USNewswire/ -- ISPE, the International Society for Pharmaceutical Engineering, announced today it is currently conducting a global survey on patient experiences with clinical trial materials. The survey is designed to obtain feedback on areas such as the suitability of clinical trial packaging, label information and design, interacting with clinical trial technologies, and transportation and storage. With a target of 2000 or more patients from around the world, this study is the first known of its kind in size and scope.

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"To ensure product integrity and patient safety, most technology and decisions in the Investigational Products (IP) arena focus on cGMP processes and activities," says ISPE President and CEO Nancy S. Berg. "As a result, decision-making can occur without good information about the downstream implications to Good Clinical Practice (GCP)-related activities at the study sites or the compliance of patients participating in the clinical trials. This study is designed to gather information that will help the pharmaceutical industry begin to close the information gap and ensure our patients receive quality products."

The survey was developed by a task force of industry experts engaged with ISPE's Investigational Products Community of Practice (IP COP). It was reviewed by global industry leaders and by experts from the non-profit Center for Information and Study on Clinical Research Participation (CISCRP). CISCRP is assisting ISPE in deploying the survey to its patient contacts around the world, handling all direct patient-related activity, and ensuring the data set ISPE ultimately analyzes is both wholly anonymous and consistent with the survey criteria.  

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