Assessment of Duplicate Publication of Chinese-Sponsored Randomized Clinical Trials

Jia, Yuanxi; Huang, Doudou; Wen, Jiajun; Qureshı, Riaz; Wang, Yehua; Rosman, Lori; Chen, Qingkun; Robinson, Karen A.; Gagnier, Joel; Ehrhardt, Stephan; Celentano, David D.

doi:10.1001/jamanetworkopen.2020.27104

Cited by 5 publications

(11 citation statements)

References 33 publications

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“…Discrepancies were discussed and solved with a third author (WW). We compared similar studies with overlapping authors, facilities recruiting patients, sample size, or outcomes to identify possible duplicates [ 26 ].…”

Section: Methodsmentioning

confidence: 99%

Assessment of redundant randomized clinical trials among patients with ST segment elevation myocardial infarction

Jia

Liang

Wang

et al. 2023

BMC Med

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Background Redundant clinical trials waste resources and unnecessarily put patients at risk for harm. The objectives of the study were to assess redundant randomized clinical trials (RCTs) conducted in mainland China or the USA among patients with ST segment elevation myocardial infarction (STEMI) and estimate the harm to patients enrolled in redundant RCTs. Methods We searched bibliographic databases for eligible RCTs comparing a routine therapy with a placebo or no treatment among patients with STEMI in mainland China or the United States. The routine therapy for STEMI included reperfusion (percutaneous coronary intervention or fibrinolytic therapy), P2Y12 receptor inhibitors, statins, and anticoagulants. Redundant RCTs were defined as those initiated or continued recruiting new patients 1 year after the experimental intervention was established as routine therapy in clinical practice guidelines. Cumulative meta-analyses were conducted to confirm the efficacy of these routine therapies. The primary outcome was the number of extra major adverse cardiac events (MACEs) attributable to the deprivation of routine therapies among patients in the control groups of redundant RCTs—that is, the number of extra MACEs that could have been prevented had these patients received routine therapy. Results Nine hundred eighty-three eligible RCTs conducted in mainland China were identified, of which 775 (78.8%) were redundant. None of the five eligible RCTs conducted in the United States were redundant. All redundant RCTs have reiterated the benefits of routine therapies for patients with STEMI, while none were cited by the 2019 clinical practice guideline for the management of STEMI. The 18,819 patients in the control groups of redundant RCTs experienced 3305 (95% CI: 3169–3441) extra MACEs, including 1091 (1014–1165) deaths, 576 (519–633) recurrent myocardial infarctions, 31 (19–42) revascularizations, 39 (23–54) strokes, 744 (679–810) heart failures, and 823 (754–893) patients with recurrent or exacerbated angina pectoris. Cumulative meta-analyses confirmed the efficacy of the routine therapies among patients in mainland China and supported using practice guidelines to define redundant RCTs. Conclusions Redundant RCTs conducted in mainland China have resulted in unnecessary MACEs among patients with STEMI. While the reasons behind redundant RCTs need to be further investigated, these results suggest potential research waste and violation of research ethics.

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Section: Methodsmentioning

confidence: 99%

Assessment of redundant randomized clinical trials among patients with ST segment elevation myocardial infarction

Jia

Liang

Wang

et al. 2023

BMC Med

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“…There are some potential limitations to the study by Jia et al 1 First, the authors hypothesized that the main article with positive findings was more likely to have subsequent duplicates than those with negative findings; however, they focused on the results in a subgroup analysis (the main article of an RCT published in Chinese) rather than on the results of the primary analysis.…”

Section: + Related Articlementioning

confidence: 99%

“…The study by Jia and colleagues analyzed randomized clinical trials (RCTs) conducted in China to identify types of duplicate publication and estimate the extent to which duplicate publication bias was associated with the language of publications.…”

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confidence: 99%

Avoidance of Duplicate Publications From Randomized Clinical Trials

2020

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The study by Jia and colleagues 1 analyzed randomized clinical trials (RCTs) conducted in China to identify types of duplicate publication and estimate the extent to which duplicate publication bias was associated with the language of publications.From English-and Chinese-language clinical trial registries, Jia and colleagues 1 identified 891 eligible RCTs that evaluated the efficacy and/or safety of drugs and were conducted between January 1, 2008, and December 31, 2014. Among 470 trials published up to August 2019, 55 (11.7%) had 75 duplicate articles. Based on the progress of recruitment and follow-up of individual RCTs, 4 duplicate types were classified, including unreferenced republication, unreferenced subgroup analysis, unreferenced interim analysis, and partial duplicate. Duplicates were also classified as cross-language duplicates or same-language duplicates. Most duplicates were cross-language duplicates (53 of 75 [70.7%]) and unreferenced republications (33 of 75 [44.0%]). Regarding duplicate publication bias, there was no evidence that the language of the main article was an effect modifier of the association between the nature of findings (positive or negative) of the main articles and the possibility of having subsequent duplicates; however, the authors stratified the main articles into 2 subgroups based on their language and found that duplicate publication bias existed when the main article was published in Chinese.

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“…During the past 10 years, the biomedical research community is witnessing a proliferation of clinical research from China [ 13 , 14 ]. Evidence-based medicine worldwide needs clinical research evidence from China [ 15 , 16 ]. During the process of promoting Chinese study evidence to the world, the quality, and transparency of clinical research in China are crucial.…”

Section: Introductionmentioning

confidence: 99%

A cross-sectional study of the endorsement proportion of reporting guidelines in 1039 Chinese medical journals

Duan

Zhao

et al. 2023

BMC Med Res Methodol

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Background Reporting quality is a critical issue in health sciences. Adopting the reporting guidelines has been approved to be an effective way of enhancing the reporting quality and transparency of clinical research. In 2012, we found that only 7 (7/1221, 0.6%) journals adopted the Consolidated Standards of Reporting Trials (CONSORT) statement in China. The aim of the study was to know the implementation status of CONSORT and other reporting guidelines about clinical studies in China. Methods A cross-sectional bibliometric study was conducted. Eight medical databases were systematically searched, and 1039 medical journals published in mainland China, Hong Kong, Macau, and Taiwan were included. The basic characteristics, including subject, language, publication place, journal-indexed databases, and journal impact factors were extracted. The endorsement of reporting guidelines was assessed by a modified 5-level evaluation tool, namely i) positive active, ii) positive weak, iii) passive moderate, iv) passive weak and v) none. Results Among included journals, 24.1% endorsed CONSORT, and 0.8% endorsed CONSORT extensions. For STROBE (STrengthening the Reporting of Observational Studies in Epidemiology), PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), STARD (An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies), CARE (CAse REport guidelines), the endorsement proportion were 17.2, 16.6, 16.4, and 14.8% respectively. The endorsement proportion for SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials), TRIPOD (Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis), AGREE (Appraisal of Guidelines, Research, and Evaluation), and RIGHT (Reporting Items for Practice Guidelines in Healthcare) were below 0.7%. Conclusions Our results showed that the implementation of reporting guidelines was low. We suggest the following initiatives including i) enhancing the level of journal endorsement for reporting guidelines; ii) strengthening the collaboration among authors, reviewers, editors, and other stakeholders; iii) providing training courses for stakeholders; iv) establishing bases for reporting guidelines network in China; v) adopting the endorsement of reporting guidelines in the policies of the China Periodicals Association (CPA); vi) promoting Chinese medical journals into the international evaluation system and publish in English.

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Assessment of Duplicate Publication of Chinese-Sponsored Randomized Clinical Trials

Cited by 5 publications

References 33 publications

Assessment of redundant randomized clinical trials among patients with ST segment elevation myocardial infarction

Assessment of redundant randomized clinical trials among patients with ST segment elevation myocardial infarction

Avoidance of Duplicate Publications From Randomized Clinical Trials

A cross-sectional study of the endorsement proportion of reporting guidelines in 1039 Chinese medical journals

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