ISPE, the International Society for Pharmaceutical Engineering, reports that it is surveying patients globally on their experiences with clinical trial materials. The goal is to gather feedback on the suitability of clinical trial packaging, label information and design, interacting with clinical trial technologies, and transportation and storage, ISPE reports in a press release. 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, it reports.
“To ensure product integrity and patient safety, most technology and decisions in the Investigational Products arena focus on cGMP processes and activities,” reported ISPE President and CEO Nancy S. Berg in the release. “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), ISPE reports. "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," reads the press release.
The stated goals of the study are to provide information and analysis that will:
- Foster an understanding of patient experiences with IPs to support informed decisions around future design and management of study materials, leading to more efficient and effective studies as well as enhancing patient compliance.
- Help the industry discern the impact of key differentiators on the patient experience with IPs, equipping professionals with information to determine when adjustments are needed to ensure the highest level of patient protocol compliance.
Eleven underwriting companies are providing support for the study. "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 reports. Supporters include:
- Almac Clinical Services
- Boehringer Ingelheim Pharma GMBH & Co.
- Catalent Pharma Solutions
- Cenduit LLC
- Merck Sharp & Dohme Corporation
- Novartis Pharma AG
- Novo Nordisk A/S
- PAREXEL International
- Pfizer Inc.
- Takeda Global Research & Development Centre (Europe), Ltd
- UCB Pharma S.A.
“Ensuring that clinical trials are as successful as they can possibly be constitutes a win for all ISPE stakeholders,” said 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 be given on June 13, 2013, at ISPE’s Conference “World-Class Supply End-to-End” in Prague, Czech Republic. ISPE will then 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.