Identification of the risks in CAR T-cell therapy clinical trials in China: a Delphi study.
CAR T-cell therapy
Delphi study
clinical trial
risk identification
subject protection
Journal
Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808
Informations de publication
Date de publication:
2020
2020
Historique:
received:
31
01
2020
accepted:
13
07
2020
entrez:
5
11
2020
pubmed:
6
11
2020
medline:
6
11
2020
Statut:
epublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 33149770
doi: 10.1177/1758835920966574
pii: 10.1177_1758835920966574
pmc: PMC7580145
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1758835920966574Informations de copyright
© The Author(s), 2020.
Déclaration de conflit d'intérêts
Conflict of interest statement: The authors declare that there is no conflict of interest.
Références
Adv Exp Med Biol. 2015;871:1-29
pubmed: 26374210
Nat Rev Drug Discov. 2010 Mar;9(3):195-201
pubmed: 20190786
Prehosp Disaster Med. 2012 Aug;27(4):351-8
pubmed: 22809442
Health Technol Assess. 1998;2(3):i-iv, 1-88
pubmed: 9561895
Stem Cell Reports. 2018 Nov 13;11(5):1021-1025
pubmed: 30428384
Int J Chron Obstruct Pulmon Dis. 2017 Sep 15;12:2735-2746
pubmed: 28979116
Stem Cell Reports. 2018 May 8;10(5):1429-1431
pubmed: 29742388
BMJ Open. 2014 Dec 30;4(12):e006682
pubmed: 25550297
Int J Obes (Lond). 2019 Dec;43(12):2573-2586
pubmed: 30655580
Brief Funct Genomics. 2020 May 20;19(3):191-200
pubmed: 31844895
J Adv Nurs. 2000 Oct;32(4):1008-15
pubmed: 11095242
Blood. 2016 Jun 30;127(26):3321-30
pubmed: 27207799
Regen Med. 2014;9(5):649-72
pubmed: 25372080
Can Fam Physician. 2007 Feb;53(2):278-86, 277
pubmed: 17872645
Nat Rev Clin Oncol. 2018 Jan;15(1):47-62
pubmed: 28925994
Expert Rev Hematol. 2019 Mar;12(3):195-205
pubmed: 30793644
Int J Cancer. 2019 Apr 15;144(8):2043-2050
pubmed: 30307029
Nat Rev Drug Discov. 2018 Jul;17(7):465-466
pubmed: 29795477
Clin Trials. 2013;10(6):967-76
pubmed: 24188963
Mil Med Res. 2016 Aug 19;3:24
pubmed: 27547444