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

Abstract BackgroundAlthough the number of cancer drug clinical trials is increasing rapidly in China, issues concerning informed consent in this research context are currently 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 drug clinical trials among adult patients in China since 2000.MethodsWe 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 to identify relevant publications since 2000. Data were extracted by three reviewers on 6 items pertaining to study type, theme and challenges.ResultsWe identified 37 unique manuscripts, from which 19 full texts were obtained and six were included in the review. A review of references cited by the six eligible studies did not result in identifying additional eligible studies. 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, quality of information disclosure, voluntariness, authorization, and procedural steps.ConclusionBased on our analysis of publications over the past two decades, there are currently frequent challenges related to various aspects of informed consent in cancer drug clinical trials in China. Furthermore, only a limited number of high-quality research studies on informed consent in cancer drug clinical 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.