Singh Pritibha, Sverdlov Oleksandr, Beckman Robert A, Burden Andrea M
Pharmacoepidemiology Group, Institute of Pharmaceutical Sciences, ETH Zurich, Zurich, Switzerland.
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Clin Transl Sci. 2025 May;18(5):e70241. doi: 10.1111/cts.70241.
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.
制药行业正日益转向在患者家中进行的去中心化临床试验（DCT），有时还包括试验材料的上门配送。传统临床试验（CT）是在研究地点进行的。研究表明，集中式和去中心化试验的碳足迹都很大，而去中心化临床试验可能提供以患者为中心的解决方案。然而，领导者必须确定如何将环境、经济和社会可持续性支柱纳入其投资组合以及随后的下游试验层面决策中。通过瑞士联邦理工学院（ETH）的SurveySelect软件设计并开展了一项在线调查，以了解在为每个支柱在去中心化临床试验和传统临床试验之间做出决策时，对优先事项和权衡的看法。该调查于2023年1月31日结束。共有447名参与者做出了回应。调查结果显示，总体人群在环境影响方面将温室气体排放列为优先事项（22.4%），在经济考量方面将试验成功概率列为优先事项（15%），在社会标准方面将患者便利性列为优先事项（23.3%）。总体而言，在所有支柱方面，去中心化临床试验环境被认为更具可持续性。参与者报告的权衡主要集中在患者参与度和将新药推向市场方面。这项调查的结果初步揭示了国际多利益相关方在选择传统临床试验和去中心化临床试验时对优先事项和权衡的看法。综合这些看法形成了三项关键建议：（1）随着实证数据的积累，需要进行模拟研究以指导跨所有支柱的整体决策；（2）保护环境；（3）保护供应链。随着实证数据的积累，这些建议为进一步研究提供了方向。
