Quality Problems Of clinical Trials in China: Evidence From quality related Studies

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2022 Apr 24

PMID 35461304

Authors

Jin Fan

Xiaobo Liu

Yuxi Li

HaiSha Xia

Rong Yang

Juan Li

Yonggang Zhang

Affiliations

Soon will be listed here.

Abstract

Background: Recently, the quality of clinical trials conducted in China has made considerable progress. However, clinical trials conducted in China still fall below the global average standard. The aim of this systematic review was to assess studies that investigated the quality of clinical trials conducted in China, summarize the issues, and provide suggestions for conducting high-quality clinical trials in China.

Methods: We comprehensively searched studies that investigated the quality of clinical trials conducted in China in the following databases from inception to December 1, 2021: National Knowledge Infrastructure, the Chinese Science and Technology Periodical Database, WanFang Data, China Biology Medicine, PubMed, and Embase. We then analyzed the issues in clinical trial registration, ethics review, implementation, and reporting. SPSS 25.0 software was used for data analysis. The data synthesis was conducted using summary statistics and a narrative format.

Results: A total of 90 studies were analyzed, there were 50 studies with 0-5 citation counts (55.56%), 18 studies with 5-10 citation counts (20%), 9 studies with 10-15 citation counts (10%), and 13 studies with more than 15 citation counts (14.44%). Eight (8.89%) studies were conducted by a supervision department, 38 (42.22%) by organizations with GCP qualification, and 44 (48.89%) by third parties. Additionally, there were some problems in the ethical review process of clinical trials, clinical trial registration process, clinical trial implementation process, and clinical trial reporting process.

Conclusions: The current study shows that the quality problems of clinical trials in China still exist. The reported problems are related to the process of clinical trials, including ethical review, registration, implementation, reporting. Due to the limited quantity and quality of included studies, the conclusions of this study need to be verified by high-quality studies.

Review Registration: Not registerated in PROSPERO.

Citing Articles

The Role and Challenges of Investigator-Initiated Trials in the Cell and Gene Therapy Products Boom in Mainland China.

Yang Y, Bian L, Cheng Y, Xu Y, Shao H, Rao J Clin Transl Sci. 2025; 18(2):e70148.

PMID: 39936621 PMC: 11815567. DOI: 10.1111/cts.70148.

Evening dosing versus morning dosing of antihypertensive medications for nocturnal hypertension: a systematic review and meta-analysis of 107 randomized controlled trials.

Lee E, Wang S, Ng W, Ramdzan S, Tse E, Chan L J Hypertens. 2024; 42(10):1653-1664.

PMID: 39196688 PMC: 11356681. DOI: 10.1097/HJH.0000000000003783.

Effects of Trazodone on Sleep: A Systematic Review and Meta-analysis.

Kokkali M, Pinioti E, Lappas A, Christodoulou N, Samara M CNS Drugs. 2024; 38(10):753-769.

PMID: 39123094 DOI: 10.1007/s40263-024-01110-2.

FAST (fast analytical simulator of tracer)-PET: an accurate and efficient PET analytical simulation tool.

Li S, Hamdi M, Dutta K, Fraum T, Luo J, Laforest R Phys Med Biol. 2024; 69(16).

PMID: 39047765 PMC: 11301696. DOI: 10.1088/1361-6560/ad6743.

The advancement of artificial intelligence in biomedical research and health innovation: challenges and opportunities in emerging economies.

da Silva R Global Health. 2024; 20(1):44.

PMID: 38773458 PMC: 11107016. DOI: 10.1186/s12992-024-01049-5.

References

Altman D, Bland J . Statistics notes. Treatment allocation in controlled trials: why randomise?. BMJ. 1999; 318(7192):1209. PMC: 1115595. DOI: 10.1136/bmj.318.7192.1209. View

Li T, Wang G, Wang L . [Problems and strategies in clinical trials of traditional Chinese medicine]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2006; 26(4):298-302. View

Tharyan P, Ghersi D . Registering clinical trials in India: a scientific and ethical imperative. Natl Med J India. 2008; 21(1):31-4. View

Taichman D, Backus J, Baethge C, Bauchner H, de Leeuw P, Drazen J . Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors. JAMA. 2016; 315(5):467-8. DOI: 10.1001/jama.2015.18164. View

Moher D, Schulz K, Altman D . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001; 357(9263):1191-4. View

Pildal J, Hrobjartsson A, Jorgensen K, Hilden J, Altman D, Gotzsche P . Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol. 2007; 36(4):847-57. DOI: 10.1093/ije/dym087. View

Yu D, Xie Y, Liao X, Zhi Y, Jiang J, Chen W . [Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica]. Zhongguo Zhong Yao Za Zhi. 2018; 43(4):833-839. DOI: 10.19540/j.cnki.cjcmm.20171107.003. View

Juni P, Altman D, Egger M . Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001; 323(7303):42-6. PMC: 1120670. DOI: 10.1136/bmj.323.7303.42. View

Wang Q, Li N, Li J, He Y, Li Y, Zhong D . A Protocol of a Guideline to Establish the Evidence Ecosystem of Acupuncture. Front Med (Lausanne). 2022; 8:711197. PMC: 8896352. DOI: 10.3389/fmed.2021.711197. View

10.

von Elm E, Altman D, Egger M, Pocock S, Gotzsche P, Vandenbroucke J . The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007; 147(8):573-7. DOI: 10.7326/0003-4819-147-8-200710160-00010. View

11.

Moher D, Hopewell S, Schulz K, Montori V, Gotzsche P, Devereaux P . CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c869. PMC: 2844943. DOI: 10.1136/bmj.c869. View

12.

Page M, Moher D, Bossuyt P, Boutron I, Hoffmann T, Mulrow C . PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ. 2021; 372:n160. PMC: 8005925. DOI: 10.1136/bmj.n160. View

13.

He Y, Li J, Li Y, Jin R, Wen Q, Li N . Strengthening the quality of clinical trials of acupuncture: a guideline protocol. BMJ Open. 2022; 12(1):e053312. PMC: 8756270. DOI: 10.1136/bmjopen-2021-053312. View

14.

Alvarez F, Meyer N, Gourraud P, Paul C . CONSORT adoption and quality of reporting of randomized controlled trials: a systematic analysis in two dermatology journals. Br J Dermatol. 2009; 161(5):1159-65. DOI: 10.1111/j.1365-2133.2009.09382.x. View

15.

Yao C . Clinical trial in China: The status and challenge of data management and statistical analysis. J Evid Based Med. 2018; 11(1):3-6. DOI: 10.1111/jebm.12295. View

16.

Lu P, Liao X, Xie Y, Wang Z . [The necessity and feasibility of establishing technical specifications for registry of Chinese medicine clinical study]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2015; 35(1):14-8. View

17.

Zhong D, Li J, Yang H, Li Y, Huang Y, Xiao Q . Tai Chi for Essential Hypertension: a Systematic Review of Randomized Controlled Trials. Curr Hypertens Rep. 2020; 22(3):25. DOI: 10.1007/s11906-020-1031-y. View

18.

Chan A, Tetzlaff J, Altman D, Laupacis A, Gotzsche P, Krleza-Jeric K . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158(3):200-7. PMC: 5114123. DOI: 10.7326/0003-4819-158-3-201302050-00583. View