Patient experiences with investigational products (IPs) are an important factor in ensuring clinical trials are conducted with optimal efficiency and safety, particularly in relation to protocol compliance.
With this in mind, the International Society for Pharmaceutical Engineering (ISPE) has launched a global survey of patient experience with clinical trial materials. Full study results are scheduled for release this coming November.
Underwritten by 11 companies engaged in clinical research, the ISPE survey is looking for feedback in areas such as the suitability of clinical-trial packaging, label information and designs; interactions with clinical-trial technologies; and the transportation and storage of IPs.
With a target poll of 2,000 or more patients from around the world, the study is “the first known of its kind in size and scope”, ISPE says.
The survey was developed by a task force of industry experts engaged with ISPE’s Investigational Products Community of Practice. It was then reviewed by industry leaders and experts from the non-profit Center for Information and Study on Clinical Research Participation (CISCRP).
CISCRP is helping out by distributing the survey to its patient contacts around the world, handling all direct patient-related activity, and ensuring the dataset ultimately analysed by ISPE is fully anonymous and consistent with the survey criteria.
The goal of the survey is to generate information and analysis that will:
- Foster understanding of patient experiences with IPs to support informed decisions around the future design and management of clinical-trial materials, leading to more efficient and effective studies as well as better patient compliance.
- Help industry discern the impact of key differentiators on patient experience with IPs, so that investigators can determine when adjustments are needed to ensure the highest level of protocol compliance.
The companies supporting the ISPE survey are Almac Clinical Services, Boehringer Ingelheim Pharma, Catalent Pharma Solutions, Cenduit, Merck Sharp & Dohme, Novartis Pharma, Novo Nordisk, Parexel International, Pfizer, Takeda Global Research & Development Centre (Europe) and UCB Pharma.
Win for all
“Ensuring that clinical trials are as successful as they can possibly be constitutes a win for all ISPE stakeholders,” commented Nancy Berg, the Society’s president and chief executive officer.
“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.”
Technology and decisions aimed at ensuring product integrity and patient safety with IPs usually focus on current Good Manufacturing Practice (cGMP) processes and activities, Berg pointed out.
As a result, she said, decision-making “can occur without good information about the downstream implications to Good Clinical Practice-related activities at the study sites or the compliance of patients participating in the clinical trials”.
ISPE will provide an update on the survey at its “World-Class Supply End-to-End” conference in Prague, Czech Republic on 13 June. Full study results will be announced in conjunction with ISPE’s Annual Meeting in November 2013.