Are randomized trials conducted in China or India biased? A comparative empirical analysis
Abstract
Context China and India are two emerging forces in undertaking randomized clinical trials. The quality of trials from these countries may affect not just their substantial populations but also their contribution to health policy throughout the world.Objective The objectives of this study were to describe and contrast the quality and biases in reports of trials conducted in China and India with a set of "gold standard" trials reported in leading European and North American journals.Method A systematic review and comparative empirical analysis of randomized controlled trial reports published in selected Chinese, Indian, and European or North American medical journals were performed. Quality was assessed against a subset of criteria from the CONSORT statement. We compared the rate of reporting of positive outcomes in clinical trials to describe potential bias.Result In total, 307 Chinese papers, 117 Indian papers, and 304 Western papers were included. Reports of Indian trials were slightly better than Chinese papers on the trial reporting quality indicators and much better than Chinese papers on reporting patients' ethical issues. However, the gold standard Western trial reports scored considerably higher on all quality criteria. Chinese papers were substantially more likely to report statistically significant results (odds ratio [OR]=2.96, 95% confidence interval [CI]=2.23-3.94; P<0.0001). Indian trials reported a similar rate of positive results to Western papers (OR=0.92, 95% CI=0.69-1.24; P=0.59).Conclusion Reporting of trials in major Chinese and Indian journals falls short of that achieved in the gold standard Western journals we appraised and may reflect underlying inadequacies in the design and conduct of these trials. Chinese trials appear biased and may selectively report positive outcomes while ignoring neutral or negative outcomes. Trialists and journal editors in China and India should adopt the CONSORT reporting guidelines, should ensure that a primary outcome is prespecified and reported, and should ensure that analysis is conducted according to the intention-to-treat principle. Ethical questions in the conduct of trials in China must be addressed.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The integrity of Chinese clinical studies has been under serious scrutiny because of insufficient ethical considerations.
“Second, the integrity of Chinese clinical studies has been under serious scrutiny because of a high proportion of studies that have reported ‘statistically significant’ results [10], no to extremely low drop-out rates [11, 12] and insufficient ethical considerations [10, 13].”
The integrity of Chinese clinical studies has been under serious scrutiny because of a high proportion of studies that have reported statistically significant results.
“Second, the integrity of Chinese clinical studies has been under serious scrutiny because of a high proportion of studies that have reported ‘statistically significant’ results [10], no to extremely low drop-out rates [11, 12] and insufficient ethical considerations [10, 13].”
Cites
Schulz (1995) · doi:10.1001/jama.1995.03520290060030 · Cited by 5,634 · see citing works
Moher, D., Pham, B., Jones, A., Cook, D. J., Jadad, A. R., Moher, M., Tugwell, P., & Klassen, T. P. (1998) · The Lancet · doi:10.1016/s0140-6736(98)01085-x · Cited by 3,560 · see citing works
Assessing the quality of controlled clinical trials
Jüni, P., Altman, D. G., & Egger, M. (2001) · BMJ · doi:10.1136/bmj.323.7303.42 · Cited by 3,309 · cited 1× · see citing works
“Our study focused on the reporting of randomized trials, which may not exactly follow the conduct of trials [11].”
MethodCollett, D. (1991) · Springer eBooks · doi:10.1007/978-1-4899-4475-7 · Cited by 1,952 · see citing works
Chan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004) · JAMA · doi:10.1001/jama.291.20.2457 · Cited by 1,845 · see citing works
Do Certain Countries Produce Only Positive Results? A Systematic Review of Controlled Trials
Vickers, A. J., Goyal, N., Harland, R., & Rees, R. W. (1998) · Controlled Clinical Trials · doi:10.1016/s0197-2456(97)00150-5 · Cited by 684 · see citing works
Soares, H. P., Daniels, S., Kumar, A., Clarke, M. J., Scott, C., Swann, S., & Djulbegović, B. (2004) · BMJ · doi:10.1136/bmj.328.7430.22 · Cited by 310 · see citing works
Freemantle, N. (2001) · BMJ · doi:10.1136/bmj.322.7292.989 · Cited by 168 · see citing works
Self-citationAn assessment of the quality of randomised controlled trials conducted in China
Zhang, D., Yin, P., Freemantle, N., Jordan, R., Zhong, N., & Cheng, K. (2008) · Trials · doi:10.1186/1745-6215-9-22 · Cited by 75 · see citing works
Self-citationLg, L., Zeng, M.-D., Ma, H., Wan Zhong, M. B., Cz, L., Cw, C., Qc, F., Wang, J.-Y., Wm, S., Cai, X., et al. (2004) · PubMed · Cited by 15 · see citing works
Clinical study of somatostatin on intestinal obstruction
Gang, P., 梁力建, 胡文杰, 王捷, 黄敏菁, 郑凯, 张卓军, & Wei, L. W. L. (2004) · Zhonghua wei-chang waike zazhi · doi:10.3760/cma.j.issn.1671-0274.2004.06.016 · Cited by 3 · see citing works
Clinical study of somatostatin on intestinal obstruction
Bao, P. (2004) · Zhonghua wei-chang waike zazhi · Cited by 2 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
The methodological and reporting quality of systematic reviews from China and the USA are similar
Tian, J., Zhang, J., Ge, L., Yang, K., & Song, F. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.12.004 · Cited by 248 · see citing works
Rasmussen, L. N., & Montgomery, P. (2018) · Systematic Reviews · doi:10.1186/s13643-018-0786-6 · Cited by 204 · see citing works
The quality of evidence in Chinese meta-analyses needs to be improved
Yao, L., Sun, R., Chen, Y., Wang, Q., Wei, D., Wang, X., & Yang, K. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.01.003 · Cited by 181 · see citing works
Oliveri, R. S., Bello, S., & Biering‐Sørensen, F. (2013) · Neurobiology of Disease · doi:10.1016/j.nbd.2013.10.014 · Cited by 150 · see citing works
Panagiotou, O. A., Contopoulos-Ioannidis, D. G., & Ioannidis, J. P. A. (2013) · BMJ · doi:10.1136/bmj.f707 · Cited by 89 · see citing works
Hundreds of thousands of zombie randomised trials circulate among us
Ioannidis, J. P. A. (2021) · Anaesthesia · doi:10.1111/anae.15297 · Cited by 76 · see citing works
The Geometric Increase in Meta-Analyses from China in the Genomic Era
Ioannidis, J. P. A., Chang, C. Q., Lam, T. K., Schully, S. D., & Khoury, M. J. (2013) · PLoS ONE · doi:10.1371/journal.pone.0065602 · Cited by 62 · see citing works
Tong, Z., Li, F., Ogawa, Y., Watanabe, N., & Furukawa, T. A. (2018) · BMC Medical Research Methodology · doi:10.1186/s12874-018-0554-2 · Cited by 61 · see citing works
Lu, Z., Cao, S., Chai, Y., Liang, Y., Bachmann, M. O., Suhrcke, M., & Song, F. (2012) · BMC Health Services Research · doi:10.1186/1472-6963-12-216 · Cited by 43 · see citing works
Is acupuncture efficacious therapy in Parkinson's disease?
Kim, H. J., & Jeon, B. S. (2014) · Journal of the Neurological Sciences · doi:10.1016/j.jns.2014.04.016 · Cited by 39 · see citing works
Ethics in Psychiatric Research: Issues and Recommendations
Jain, S., Kuppili, P. P., Deep, R., & Sagar, R. (2017) · Indian Journal of Psychological Medicine · doi:10.4103/ijpsym.ijpsym_131_17 · Cited by 34 · see citing works
Tharyan, P., George, A. T., Kirubakaran, R., & Barnabas, J. P. (2012) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.11.011 · Cited by 30 · see citing works
Reveiz, L., Villanueva, E., Iko, C., & Simera, I. (2013) · Cadernos de Saúde Pública · doi:10.1590/s0102-311x2013000600006 · Cited by 28 · see citing works
Murthy, S., Mandl, K. D., & Bourgeois, F. T. (2015) · Health Research Policy and Systems · doi:10.1186/s12961-015-0019-6 · Cited by 27 · see citing works
Kandala, N., Connock, M. J., Grove, A., Sutcliffe, P. A., Mohiuddin, S., Hartley, L., Court, R. A., Cummins, E., Gordon, C., & Clarke, A. (2013) · BMJ Open · doi:10.1136/bmjopen-2013-002852 · Cited by 25 · see citing works
Fan, H., & Song, F. (2015) · Scientific Reports · doi:10.1038/srep13221 · Cited by 24 · see citing works
Sheng, C., Chen, Z., Cui, H., Yang, A., Wang, C., Wang, Z., Su, N.-X., & Tang, T. (2015) · Chinese Journal of Integrative Medicine · doi:10.1007/s11655-015-2287-y · Cited by 19 · see citing works
About the issue of including or excluding studies from China in systematic reviews
Leucht, S., Li, C., Davis, J. M., Bighelli, I., Zhu, Y., & Furukawa, T. A. (2022) · Schizophrenia Research · doi:10.1016/j.schres.2022.01.001 · Cited by 16 · see citing works
Schneider‐Thoma, J., Zhu, Y., Qin, M., Dong, Y., Guan, S., Wang, J., Tian, J., Lin, X., Rodolico, A., Siafis, S., et al. (2026) · The Lancet · doi:10.1016/s0140-6736(25)02365-7 · Cited by 16 · see citing works
Research Misconduct Policy in Biomedicine: Beyond the Bad-Apple Approach
Redman, B. K. (2013) · Project Muse (Johns Hopkins University) · Cited by 15 · see citing works
Zou, C., Lu, F., Mao, W., & Liu, X. (2012) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2011.0041 · Cited by 13 · see citing works
Contopoulos‐Ioannidis, D. G., Tseretopoulou, X., Ancker, M., Walterspiel, J. N., Panagiotou, O. A., Maldonado, Y., & Ioannidis, J. P. A. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.02.032 · Cited by 10 · see citing works
Selective noradrenaline reuptake inhibitors for schizophrenia
Matthews, P., Horder, J., & Pearce, M. J. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010219.pub2 · Cited by 9 · see citing works
Randomized Trials Published in Chinese or Western Journals
Purgato, M., Cipriani, A., & Barbui, C. (2012) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e3182546ef6 · Cited by 9 · see citing works
Evidence-based medicine: can the evidence be trusted?
Tharyan, P. (2011) · Indian Journal of Medical Ethics · doi:10.20529/ijme.2011.081 · Cited by 8 · see citing works
Wei, Y., Lorenz, C., Siafis, S., Schneider‐Thoma, J., Kim, D. D., Wu, H., Nomura, N., Dong, S., Furukawa, Y., Zhu, Y., et al. (2025) · EClinicalMedicine · doi:10.1016/j.eclinm.2025.103583 · Cited by 7 · see citing works
Tedesco, D., Farid‐Kapadia, M., Offringa, M., Bhutta, Z. A., Maldonado, Y., Ioannidis, J. P. A., & Contopoulos‐Ioannidis, D. G. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.11.016 · Cited by 7 · see citing works
Vassou, C., D'Cunha, N. M., Naumovski, N., & Panagiotakos, D. B. (2020) · Journal of Diabetes & Metabolic Disorders · doi:10.1007/s40200-020-00551-y · Cited by 6 · see citing works
Predatory publishing in India: has the system failed us?
Hegde, A., & Patil, N. (2020) · Acta Neurochirurgica · doi:10.1007/s00701-020-04644-8 · Cited by 6 · see citing works
Social robots: a meta-analysis of learning outcomes
de Winter, J. D., Dodou, D., Moorlag, F., & Broekens, J. (2026) · Frontiers Robotics AI · doi:10.3389/frobt.2025.1735198 · Cited by 4 · see citing works
Editorial policies aimed at improving the transparency and validity of published research
Rao, T. S., & Tharyan, P. (2011) · Indian Journal of Psychiatry · doi:10.4103/0019-5545.86793 · Cited by 5 · see citing works
Ethics in Psychiatric Research: Issues and Recommendations
Malla, A. A., & Bhat, N. M. (2016) · International Journal of Indian Psychology · doi:10.25215/0304.218 · Cited by 4 · see citing works
Bowater, R. J., Hartley, L., & Lilford, R. J. (2014) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2014.03.005 · Cited by 4 · see citing works
When conducting a systematic review, can one trade search efficiency for potential publication bias?
Kim, T., Kang, J. W., & Lee, M. S. (2022) · Research Synthesis Methods · doi:10.1002/jrsm.1596 · Cited by 3 · see citing works
Primary tobacco prevention in China--a systematic review.
Schröer-Günther, M., Zhou, M., Gerber, A., & Passon, A. M. (2011) · PubMed · Cited by 3 · see citing works
Acupuncture for low back pain: ritual healing or medicine?
Kavoussi, B. (2015) · Focus on Alternative and Complementary Therapies · doi:10.1111/fct.12161 · Cited by 2 · see citing works
Leucht, S., Siafis, S., Schneider‐Thoma, J., Tajika, A., Priller, J., Davis, J. M., & Furukawa, T. A. (2024) · Schizophrenia · doi:10.1038/s41537-024-00442-8 · Cited by 2 · see citing works
Additional considerations for increasing placebo response
vanderVaart, S., & Hogan, M. (2016) · Pain · doi:10.1097/j.pain.0000000000000672 · Cited by 2 · see citing works
Acupuncture for chronic neck pain
Lee, M. S., Nielsen, A., Kim, T., Ha, I., Harbin, S., & Wieland, L. S. (2019) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013477 · Cited by 1 · see citing works
Effectiveness of Primary Care-Based Interventions Promoting Physical Activity: A Meta-Analysis Study
Sarısaltık, A., Lüleci, N. E., & Hıdıroğlu, S. (2023) · OSMANGAZİ JOURNAL OF MEDICINE · doi:10.20515/otd.1312615 · Cited by 1 · see citing works
Dong, Y., Wang, J., Guan, S., Zhu, Y., Qin, M., Rodolico, A., Siafis, S., Bighelli, I., Davis, J. M., Priller, J., et al. (2026) · Schizophrenia Research · doi:10.1016/j.schres.2026.06.022 · Cited by 1 · see citing works
Forty-five years of schizophrenia trials in Italy: a survey
Purgato, M., Adams, C. E., & Barbui, C. (2012) · Trials · doi:10.1186/1745-6215-13-35 · Cited by 1 · see citing works
Controversies with Clinical Trial Regulations in Low- and Middle-Income Countries
Rake, B. (2022) · Springer eBooks · doi:10.1007/978-3-030-99680-2_23 · Cited by 1 · see citing works
Boffa, A., Previtali, D., Frattura, G. D. L., Vannini, F., Candrian, C., & Filardo, G. (2021) · International Orthopaedics · doi:10.1007/s00264-021-05040-2 · Cited by 1 · see citing works
Clinical trials in India: issues with adherence to CONSORT statements
Sarangi, S. C., & Medhi, B. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.03.002 · Cited by 1 · see citing works
Hartley, L. (2012) · University of Birmingham Institutional Research Archive (University of Birmingham)
Author's response to Hopper Koppelman's letter: ‘questions on rationale’
Kavoussi, B. (2015) · Focus on Alternative and Complementary Therapies · doi:10.1111/fct.12180
Hartley, L., Girling, A. J., Bowater, R. J., & Lilford, R. J. (2014) · Journal of Epidemiology & Community Health · doi:10.1136/jech-2013-203646
Bowater, R. J., Hartley, L., & Lilford, R. J. (2015)
Pharmacological treatments for generalised anxiety disorder – Authors' reply
Freemantle, N., Slee, A. E., & Nazareth, I. (2019) · The Lancet · doi:10.1016/s0140-6736(19)31415-1
Self-citationHabilidades Motoras de Crianças em Berçários:
Guedes, S., Caetano, V., Avelino, P. R., & de Menezes, K. K. P. (2020) · Revista Neurociências · doi:10.34024/rnc.2020.v28.10165
- Authors
- Zhang, D., Freemantle, N., & Cheng, K. K.
- Affiliations
- University of Birmingham (GB)
- Corresponding author
- Freemantle, Nick
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2011-01
- Volume
- 64
- Issue
- 1
- Pages
- 90-95
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2079967028
- Cited by
- 51
- References
- 12
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 1 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 4 · 2019: 2 · 2018: 3 · 2017: 3 · 2016: 4 · 2015: 6 · 2014: 3 · 2013: 6 · 2012: 6
- FWCI
- 5.29
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- randomized controlled trials, trial reporting quality, reporting bias, selective outcome reporting, CONSORT statement, China, India, intention-to-treat analysis
- MeSH terms
- China, Europe, Humans, India, Periodicals as Topic, Reference Standards, Randomized Controlled Trials as Topic, Publication Bias
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
