'Somebody Might Actually Make Up Data': An Empirical Qualitative Study on How to Screen for Fake Research

Parker, Lisa; Boughton, Stephanie; Lawrence, Rosa; Bero, Lisa

doi:10.2139/ssrn.4071671

Cited by 2 publications

(2 citation statements)

References 15 publications

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“…A group of researchers recently reported results from a qualitative international interview study with the aim to better understand the views of research integrity experts about what might make a study problematic or untrustworthy and what warning signs could be used in a practical screening tool to identify potentially problematic studies. 16 Cochrane defines a "problematic study" as "any published or unpublished study where there are serious questions about the trustworthiness of the data or findings, regardless of whether the study has been formally retracted. Scientific misconduct will not be the only reason that a study might be problematic; problems may result from poor research practices or honest errors."…”

Section: Introductionmentioning

confidence: 99%

“…Mechanisms for identifying studies with fabricated or false data, or where problems with research conduct amounting to failure of research integrity, is an active area of research. A group of researchers recently reported results from a qualitative international interview study with the aim to better understand the views of research integrity experts about what might make a study problematic or untrustworthy and what warning signs could be used in a practical screening tool to identify potentially problematic studies 16 . Cochrane defines a “problematic study” as “any published or unpublished study where there are serious questions about the trustworthiness of the data or findings, regardless of whether the study has been formally retracted.…”

Section: Introductionmentioning

confidence: 99%

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Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis

Weibel

Popp

Reis

et al. 2022

Research Synthesis Methods

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Evidence synthesis findings depend on the assumption that the included studies follow good clinical practice and results are not fabricated or false.Studies which are problematic due to scientific misconduct, poor research practice, or honest error may distort evidence synthesis findings. Authors of evidence synthesis need transparent mechanisms to identify and manage problematic studies to avoid misleading findings. As evidence synthesis authors of the Cochrane COVID-19 review on ivermectin, we identified many problematic studies in terms of research integrity and regulatory compliance. Through iterative discussion, we developed a research integrity assessment (RIA) tool for randomized controlled trials for the update of this Cochrane review. In this paper, we explain the rationale and application of the RIA tool in this case study. RIA assesses six study criteria: study retraction, prospective trial registration, adequate ethics approval, author group, plausibility of methods (e.g., randomization), and plausibility of study results. RIA was used in the Cochrane review as part of the eligibility check during screening of potentially eligible studies. Problematic studies were excluded and studies with open questions were held in awaiting classification until clarified. RIA decisions were made independently by two authors and reported transparently. Using the RIA tool resulted in the exclusion of >40% of studies in the first update of the review. RIA is a complementary tool prior to assessing "Risk of Bias" aiming to establish the integrity and authenticity of studies. RIA provides a platform for urgent development of a standard approach to identifying and managing problematic studies.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis

Weibel

Popp

Reis

et al. 2022

Research Synthesis Methods

View full text Add to dashboard Cite

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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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'Somebody Might Actually Make Up Data': An Empirical Qualitative Study on How to Screen for Fake Research

Cited by 2 publications

References 15 publications

Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis

Identifying and managing problematic trials: A research integrity assessment tool for randomized controlled trials in evidence synthesis

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

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