Do Chinese Researchers Conduct Ethical Research and Use Ethics Committee Review in Clinical Trials of Anti-Dementia Drugs? An Analysis of Biomedical Publications Originating from China

Article type: Review Article

Authors: Zeng, Lingfeng^{a; b; 1} | Liang, Weixiong^{c; 1} | Pan, Jianke^d | Cao, Ye^e | Liu, Jun^{b; *} | Wang, Qi^{a; c; *} | Wang, Lu^f | Zou, Yuanping^g | Wang, Kezhu^h | Kong, Lingshuo^a | Xie, Hui^d | Xu, Weihua^a | Li, Weirong^a | Zhao, Wei^a | Mi, Suiqing^a | Chen, Yunbo^a | Cheng, Shuyi^a | Li, Xiaoyan^b | Cao, Qian^b | Zeng, Xing^b | Wang, Ningsheng^{a; g}

Affiliations: [a] Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, China | [b] Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China | [c] Drug Clinical Trial Institute, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China | [d] The 2nd School of Clinic Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China | [e] Clinical Trials Center, Cancer Center, Sun Yat-sen University/National Drug Clinical Trial Institute, Guangzhou, China | [f] Ethics Review Committee, World Federation of Chinese Medicine Societies, Beijing, China | [g] Guangzhou University of Chinese Medicine, Guangzhou, China | [h] Institute of Medicinal Plant Development of Chinese Academy of Medical Sciences, Beijing, China

Correspondence: [*] Correspondence to: Qi Wang, Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. Tel.: +86 20 81887233; Fax: +86 20 81874903; E-mail: [email protected].

Correspondence: [*] Correspondence to: Jun Liu, Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. E-mail: [email protected].

Note: [1] These authors contributed equally to this work.

Abstract: Background: Medical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association. Objective: The purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs. Methods: Four medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software. Results: Among those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009. Conclusion: Compared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.

Keywords: Anti-dementia drugs, clinical trials, ethical protection, ICP, REC

DOI: 10.3233/JAD-150858

Journal: Journal of Alzheimer's Disease, vol. 52, no. 3, pp. 813-823, 2016