10 June 2013
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.
“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.
The goals of the study are to provide information and analysis that will:
The study has been made possible by the generous support of eleven underwriting companies. Their investment in the mission and work of ISPE has allowed the task force to design and carry out this comprehensive project to the ultimate benefit patients around the world. ISPE wishes to thank the underwriters including:
“Ensuring that clinical trials are as successful as they can possibly be constitutes a win for all ISPE stakeholders,” says Berg. “Moreover, in the future we believe that the experience of the patient will and should have a bigger impact on cGMP decisions concerning clinical materials. This survey is a critical first step.”
An update on the study will occur 13 June 2013 at ISPE’s Conference “World-Class Supply End-to-End” in Prague, Czech Republic. On that date and thereafter, ISPE will host a website section devoted to its Patient Initiative featuring the latest information about the survey at www.ISPE.org/PatientInitiative. In July, an article providing background on the study design will be published in Pharmaceutical Engineering Magazine. Full study results will be announced in conjunction with ISPE’s Annual Meeting in November 2013.
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.
For more information contact:
ISPE Communications Manager