Informed consent in cancer clinical drug trials in China: a narrative literature review of the past 20 years

Xing Liu; Xiaoran Lu; Wei Zhou; Jessica Hahne; Kaveh Khoshnood; Xiaoting Shi; Yuqiong Zhong; Xiaomin Wang

doi:10.1186/s13063-023-07482-y

Informed consent in cancer clinical drug trials in China: a narrative literature review of the past 20 years

Trials. 2023 Jul 7;24(1):445. doi: 10.1186/s13063-023-07482-y.

Authors

Xing Liu¹, Xiaoran Lu², Wei Zhou³, Jessica Hahne⁴, Kaveh Khoshnood⁵, Xiaoting Shi⁶, Yuqiong Zhong², Xiaomin Wang⁷

Affiliations

¹ Medical Ethics Committee, Xiangya Hospital of Central South University, 87 Xiangya Road, Changsha, 410008, Hunan, People's Republic of China.
² School of Humanities, Central South University, Changsha, 410075, Hunan, People's Republic of China.
³ School of Public Administration, Hunan University, Changsha, 410023, Hunan, People's Republic of China.
⁴ Department of Psychological & Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.
⁵ Yale School of Public Health, Yale University, 60 College Street, New Haven, CT, 06520, USA.
⁶ Department of Environmental Health Sciences, Yale School of Public Health, 60 College St, New Haven, CT, 06520, USA.
⁷ Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, People's Republic of China. xiaominwang@csu.edu.cn.

Abstract

Background: Although the number of cancer clinical drug trials is increasing rapidly in China, issues concerning informed consent in this research context are understudied. By performing a narrative literature review, we aim to describe the current situation and identify the most salient challenges affecting informed consent in cancer clinical drug trials among adult patients in China since 2000.

Methods: We searched Web of Science (WOS), PubMed, Scopus, EMBASE, the Cochrane Library databases, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database on Disc (CBMdisc), Chinese Scientific Journals Fulltext Database (CQVIP), and WANFANG Data to identify relevant publications since 2000. Data were extracted by three reviewers on six items pertaining to study type, theme, and challenges.

Results: We identified 37 unique manuscripts, from which 19 full texts were obtained and six were included in the review. All six studies were published in Chinese journals, and the publication years of the majority (five out of six) of the studies were 2015 or later. The authors of the six studies were all from clinical departments or ethical review committees at five hospitals in China. All of the included publications were descriptive studies. Publications reported challenges related to the following aspects of informed consent: information disclosure, patient understanding, voluntariness, authorization, and procedural steps.

Conclusion: Based on our analysis of publications over the past two decades, there are currently frequent challenges related to various aspects of informed consent in cancer clinical drug trials in China. Furthermore, only a limited number of high-quality research studies on informed consent in cancer clinical drug trials in China are available to date. Efforts toward improvement of informed consent practice, in the form of guidelines or further regulations in China, should draw on both experience from other countries and high-quality local evidence.

Keywords: Cancer drugs; Clinical trials; Informed consent; Narrative review; Research ethics.

Publication types

Review

MeSH terms

Adult
Data Management
Disclosure
Humans
Informed Consent*
Narration
Neoplasms* / drug therapy

Grants and funding

2019SK1010/Major Scientific and Technological Projects for Collaborative Prevention and Control of Birth Defects in Hunan Province