80% of China’s clinical trial data are fraudulent, investigation finds

Woodhead, Michael

doi:10.1136/bmj.i5396

Cited by 72Pharmaceutical industry and healthcareAcademic integrity and plagiarismBiomedical Ethics and Regulation

80% of China’s clinical trial data are fraudulent, investigation finds

Woodhead, Michael·2016·BMJ

DOI 10.1136/bmj.i5396

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Abstract

Just over 80% of clinical trial data submitted to support new drug registrations in China have been revealed as fraudulent or substandard by the country’s drug regulator. An investigation of data for 1622 new drugs submitted to China’s State Food and Drug Administration (CFDA) for registration said that 1308 of the applications should be withdrawn because they contained fabricated, flawed, or inadequate data from clinical trials.1 In a damning report released on 9 September the CFDA described the findings of widespread fraud as shocking and vowed to crack down on what it described as a “chaotic” situation in the country’s clinical trials industry. Much of the blame was attributed to the country’s loosely regulated clinical research organisations, which industry insiders claimed operate in …

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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].”
From Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study (2018) · cites this paper as [13]
News in the past few years has implicated an alarmingly high proportion of plagiarism, falsification or fabrication in the scientific and clinical literature from China.
“Moreover, news in the past few years has implicated an alarmingly high proportion of plagiarism, falsification or fabrication in the scientific and clinical literature from China [13–15].”
From Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study (2018) · cites this paper as [13]
The investigators' experiences indicate that identifying RCTs at low risk of bias among those from the CNKI can be onerous: simple inquiry with study authors may not be sufficient, and ascertaining the pre-published protocol and source data may be required.
“However, our experiences in the course of the present study indicate that identifying RCTs at low risk of bias among those from the CNKI can be an onerous task: simple inquiry with the study authors may not be sufficient; ascertaining the pre-published protocol and the source data may be required [13].”
From Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study (2018) · cites this paper as [13]
Some individuals suggest clinical trial fraud is "an open secret" in China.
“Some individuals suggest clinical trial fraud is “an open secret” in China [13].”
From Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study (2018) · cites this paper as [13]

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Authors: Woodhead, M.
Corresponding author: Woodhead, Michael
Venue: BMJ
Publisher: BMJ
Published: 2016-10-05
Volume: 355
Pages: i5396
ISSN: 1756-1833 (ISSN-L)
DOI: 10.1136/bmj.i5396
OpenAlex: W2528692259
Cited by: 72
References: 0
Citations by year: 2026: 3 · 2025: 7 · 2024: 4 · 2023: 9 · 2022: 9 · 2021: 15 · 2020: 4 · 2019: 5 · 2018: 8 · 2017: 6 · 2016: 2
Type: other
Language: en
Open access: closed
Licence: www.bmj.org/licenses/tdm/1.0/terms-and-conditions.html (tdm)
Locations: BMJ (publishedVersion)
PubMed (publishedVersion)
HighWire Press Open Archive (submittedVersion)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Social Sciences › Safety Research › Academic integrity and plagiarism
Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
Keywords: data fabrication, drug registration, State Food and Drug Administration, regulatory oversight, clinical research regulation, pharmaceutical industry, China
MeSH terms: China, Clinical Trials as Topic, Drug Industry, Government Agencies, Humans, Scientific Misconduct, Drug Approval, Federal Government

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80% of China’s clinical trial data are fraudulent, investigation finds

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