Identification of the risks in CAR T-cell therapy clinical trials in China: a Delphi study. (October 2020)

• Record Type: Journal Article
• Authors: Wu, Weijia; Huo, Yan; Ding, Xueying; Zhou, Yuhong; Gu, Shengying; Gao, Yuan
• Is Part Of: Therapeutic advances in medical oncology. Volume 12(2020)
• Publication Date: 2020-10
• Subjects: CAR T-cell therapy -- clinical trial -- Delphi study -- risk identification -- subject protection; Oncology -- Periodicals; Cancer -- Treatment -- Periodicals; 616.994005
• DOI: 10.1177/1758835920966574
• Languages: English
• ISSNs: 1758-8340

Abstract

Aims: Within the past few years, there has been tremendous growth in clinical trials of chimeric antigen receptor (CAR) T-cell therapies. Unlike those of many small-molecule pharmaceuticals, CAR T-cell therapy clinical trials are fraught with risks due to the use of live cell products. The aim of this study is to reach a consensus with experts on the most relevant set of risks that practically occur in CAR T-cell therapy clinical trials. Methods: A Delphi method of consensus development was used to identify the risks in CAR T-cell therapy clinical trials, comprising three survey rounds. The expert panel consisted of principal investigators, clinical research physicians, members of institutional ethics committees, and Good Clinical Practice managers. Results: Of the 24 experts invited to participate in this Delphi study, 20 participants completed Round 1, Round 2, and Round 3. Finally, consensus (defined as >80% agreement) was achieved for 54 risks relating to CAR T-cell clinical trials. Effective interventions related to these risks are needed to ensure the proper protection of subject health and safety. Conclusion: The Delphi method was successful in gaining a consensus on risks relevant to CAR T-cell clinical trials in a geographically diverse expert association. It is hoped that this work can benefit future risk-based quality management in clinical trials and can potentially promote the better development of CAR T-cell therapy products.