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. 2020 Oct 17:12:1758835920966574.
doi: 10.1177/1758835920966574. eCollection 2020.

Identification of the risks in CAR T-cell therapy clinical trials in China: a Delphi study

Weijia Wu  1 , Yan Huo  2 , Xueying Ding  3 , Yuhong Zhou  4 , Shengying Gu  5 , Yuan Gao  6
Affiliations

Identification of the risks in CAR T-cell therapy clinical trials in China: a Delphi study

Weijia Wu et al. Ther Adv Med Oncol. .

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.

Keywords: CAR T-cell therapy; Delphi study; clinical trial; risk identification; subject protection.

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Conflict of interest statement

Conflict of interest statement: The authors declare that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
Overview of the Delphi process. ADR, adverse drug reaction; AE, adverse event; CAR, chimeric antigen receptor; SAE, serious adverse event.
See this image and copyright information in PMC

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