Integrating Sustainability Pillars Into Trial Design Decision-Making: Results of an International Survey

将可持续性支柱纳入试验设计决策:一项国际调查的结果

阅读:1

Abstract

The pharmaceutical industry is increasingly shifting to decentralized clinical trials (DCTs) conducted at the patient's home, sometimes including trial material home delivery. The traditional clinical trial (CT) is conducted at the investigational site. Research suggests that centralized and decentralized trials have a large carbon footprint, with DCTs potentially providing patient-centric solutions. However, leaders must determine how to integrate environmental, economic, and social sustainability pillars into their portfolios and subsequent downstream trial-level decisions. An online survey was designed and deployed via Eidgenössische Technische Hochschule's (ETH, Swiss Federal Institute of Technology) SurveySelect software to capture perceptions of priorities and tradeoffs when deciding between a DCT and a traditional CT for each pillar. The survey closed on 31st January 2023. A total of 447 participants responded. The findings revealed that the overall cohort prioritized greenhouse gas emissions (22.4%) for environmental impact, trial probability of success (15%) for economic considerations, and patient convenience (23.3%) for social criteria. Overall, the DCT setting was perceived as more sustainable in all pillars. Participants reported tradeoffs centered on patient engagement and bringing new medicines to the market. The results from this survey provide initial insights into international multistakeholder perceptions of the priorities and tradeoffs when choosing between a traditional CT and DCT. The synthesized perceptions inform three key recommendations: the need (1) for simulation studies to guide holistic decision-making across all pillars as empirical data accumulates, (2) to protect the environment, and (3) to protect the supply chain. As empirical data accumulates, these recommendations provide directionality for further research.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。