Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials.

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-05-01 Epub Date: 2024-02-16 DOI:10.1007/s43441-024-00618-5

Abigail Dirks, Maria Florez, Francois Torche, Steve Young, Brian Slizgi, Kenneth Getz

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Abstract

Background: Risk-based monitoring (RBM) and risk-based quality management (RBQM) offer a compelling approach to increase efficiency, speed and quality in clinical trials by prioritizing and mitigating risks related to essential safety and efficacy data. Since 2013, the FDA and EMA have encouraged the use of RBM/RBQM, however adoption has been slow with limited understanding of the barriers to adoption.

Methods: The Tufts Center for the Study of Drug Development conducted an online survey among pharmaceutical, biotechnology, and contract research organizations and gathered 206 responses on 32 distinct RBQM practices.

Results: On average, companies implemented RBQM in 57% of their clinical trials. Lower levels of adoption were observed among companies conducting fewer than 25 trials annually (48%) compared to those conducting more than 100 trials annually (63%). Primary barriers to adoption include lack of organizational knowledge and awareness, mixed perceptions of the value proposition of RBQM, and poor change management planning and execution. Insights into improving the level of adoption are discussed.

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全面评估临床试验中采用基于风险的质量管理的情况。

背景：基于风险的监测（RBM）和基于风险的质量管理（RBQM）通过优先考虑和降低与基本安全性和有效性数据相关的风险，为提高临床试验的效率、速度和质量提供了令人信服的方法。自 2013 年以来，FDA 和 EMA 一直鼓励使用 RBM/RBQM，但由于对采用 RBM/RBQM 的障碍了解有限，因此采用 RBM/RBQM 的速度一直很慢：塔夫茨药物开发研究中心对制药、生物技术和合同研究组织进行了在线调查，收集了 206 份关于 32 种不同的 RBQM 实践的回复：平均而言，有 57% 的公司在其临床试验中实施了 RBQM。与年试验次数超过 100 次的公司（63%）相比，年试验次数少于 25 次的公司（48%）采用 RBQM 的比例较低。采用的主要障碍包括缺乏组织知识和意识、对 RBQM 的价值主张认识不一以及变革管理规划和执行不力。本文讨论了提高采用水平的见解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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