Dirks Abigail, Florez Maria, Torche Francois, Young Steve, Slizgi Brian, Getz Kenneth
Tufts Center for the Study of Drug Development, Tufts School of Medicine, Boston, MA, USA.
CluePoints, Brussels, Belgium.
Ther Innov Regul Sci. 2024 May;58(3):520-527. doi: 10.1007/s43441-024-00618-5. Epub 2024 Feb 16.
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.
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.
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.
基于风险的监查（RBM）和基于风险的质量管理（RBQM）提供了一种引人注目的方法，通过对与基本安全性和有效性数据相关的风险进行优先级排序和缓解，来提高临床试验的效率、速度和质量。自2013年以来，美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）鼓励使用RBM/RBQM，然而采用率一直较低，对采用障碍的理解有限。
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一项在线调查，收集了关于32种不同RBQM实践的206份回复。
平均而言，公司在其57%的临床试验中实施了RBQM。与每年开展超过100项试验的公司（63%）相比，每年开展少于25项试验的公司采用率较低（48%）。采用的主要障碍包括缺乏组织知识和意识、对RBQM价值主张的看法不一，以及变革管理规划和执行不力。文中讨论了提高采用率的见解。
