Research integrity in clinical trials: innocent errors and spin versus scientific misconduct

Núñez-Núñez, María; Andrews, Jeffrey C; Fawzy, Mohamed; Bueno‐Cavanillas, Aurora; Khan, Khalid S.

doi:10.1097/gco.0000000000000807

Cited by 14 publications

(11 citation statements)

References 57 publications

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“…Our statement provides the agreed set of values and concepts concerning integrity of RCT. For guiding behaviour, each stakeholder organisation would need to prepare manuals with specifications of the conduct that must be adhered to when participating in and carrying out RCTs 45 . Hence, the principles summarised in our work serve as a basis for creating implementation plans, manuals, standards and policies at stakeholder institutions and organisations to help inculcate integrity in RCTs.…”

Section: Discussionmentioning

confidence: 99%

“…In this regard it is important to factually examine the retraction landscape. The current distribution of numbers of retracted clinical studies in the Retraction Watch Database 44 shows that the USA, Japan and China rank at the top, not Egypt (Figure 4). The consensus statement is useable by any interested party as it gives general guidance applicable in the RCT research discipline.…”

Section: Limitations and Strengthsmentioning

confidence: 99%

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International multi‐stakeholder consensus statement on clinical trial integrity

Khan

Fawzy²,

Chien³

et al. 2023

BJOG

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Objective To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi‐stakeholder consensus. Methods The consensus was developed via: multi‐country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two‐round modified Delphi survey with consensus threshold based on the average percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer‐reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder‐provided, 46 systematic review‐generated, 8 supported by both) in the initial long list, with eight additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder‐provided, 41 systematic review‐generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n = 6), design and approval (n = 11), conduct and monitoring (n = 19), reporting of protocols and findings (n = 20), post‐publication concerns (n = 12), and future research and development (n = 13). Conclusion Implementation of this multi‐stakeholder consensus statement is expected to enhance RCT integrity.

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Section: Discussionmentioning

confidence: 99%

Section: Limitations and Strengthsmentioning

confidence: 99%

International multi‐stakeholder consensus statement on clinical trial integrity

Khan

Fawzy²,

Chien³

et al. 2023

BJOG

Self Cite

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“…36 This requires a shift in focus from the ‘publish or perish’ mindset, where publication pressure is associated with a higher prevalence of questionable research practices, 37 to prioritising and institutionalising responsible research methodology and practice. 7,38 Further, journal editors and publishers have a responsibility to uphold integrity by ensuring that they only publish research that has been conducted in accordance with internationally accepted guidelines. 39 To achieve this, they should routinely screen manuscripts for integrity issues, 40 and we support arguments to require sharing of raw data prior to publication.…”

Section: Discussionmentioning

confidence: 99%

Development of the Individual Participant Data (IPD) Integrity Tool for assessing the integrity of randomised trials using individual participant data

Hunter,

Aberoumand,

Libesman

et al. 2023

Preprint

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IntroductionIncreasing concerns about integrity in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools focus on evaluating aggregate or published data, though some trustworthiness issues may only be detected upon scrutiny of individual participant data (IPD). To address this, we developed the IPD Integrity Tool for detecting integrity issues in randomised controlled trials with IPD available. This manuscript describes the development of this tool.MethodsWe conducted a literature review to collate and map existing integrity items. These were discussed with an expert advisory group, and agreed items were included in a standardised tool and automated where possible. We piloted this tool in two IPD meta-analyses, and conducted preliminary validation checks on 13 datasets with and without known integrity issues in a blinded manner.ResultsThe literature review identified 120 integrity items: 54 could be conducted at the publication or aggregate data (AD) level, 48 required IPD, and 18 were possible with aggregate data, but more comprehensive with IPD. Based on these items, an initial reduced tool was developed in a consensus process involving 13 advisors with different backgrounds (countries, profession, education). This initial tool included 11 items across four domains for AD, and 12 items across 8 domains requiring IPD. The tool was iteratively refined throughout piloting on two IPD meta-analyses including a total of 116 trials (73 with IPD, and 43 with only AD available), and preliminary validation using an additional 13 datasets. All five studies with known integrity issues were accurately identified during validation. The final version of the tool included seven domains with 13 items for AD and eight domains with 18 items requiring IPD.ConclusionsThe quality of evidence informing health care relies on trustworthy data. This manuscript describes the development of a tool to enable researchers, editors, and other stakeholders to detect integrity issues in randomised trials using IPD. Detailed instructions on the application of this tool will be published subsequently.

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“… 6 , 9 Such registration is also encouraged to allow verification that the original systematic review protocol has been followed and any subsequent deviation from this protocol are fully reported with justifications in the published manuscript for the purpose of transparency. 10 Hence, details of the registration should also be provided in the manuscript. There are many registration platforms e.g.…”

Section: Introductionmentioning

confidence: 99%

Systematic Review Reporting - Writing concisely and precisely

Chien

Khan²

2023

Pak J Med Sci

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Systematic reviews rank at the top of the evidence hierarchy. Concise writing implies drafting the systematic review article succinctly, i.e. using as few words to express as full an extent of the research effort as possible. Precise writing means drafting the text with accuracy especially with respect to the methodological and statistical aspects. The Abstract ought to be succinct and structured to allow for editors, peer reviewers and readers to get the gist of the key aspects of the systematic review with a quick read. The readership needs to be able to critically appraisal systematic reviews for their internal and external validity rapidly. The Abstract also needs to be standalone, representing an independent summary that can be fully understood without the need for reading the full paper. The standard structure of the main text of a scientific article called IMRaD (Introduction, Methods, Results and Discussion) applies equally to systematic reviews in the same way as it does to any other kinds of research manuscripts whether related to laboratory experiments or clinical trials. Restricting the word count limits to those imposed by journals may at first seem difficult, even unfair, to systematic reviewers. However, with the availability of online appendices to transparently and fully report the details of the methods, results and other aspects of the work undertaken allows for a succinct print or PDF article. Writing a shorter manuscript is more effortful than writing a longer report. This commentary is aimed at novice systematic reviewers to help them learn the written and unwritten writing rules in order to assist them in producing impactful publications to support evidence-based medicine. doi: https://doi.org/10.12669/pjms.39.2.7428 How to cite this: Chien PFW, Khan KS. Systematic Review Reporting - Writing concisely and precisely. Pak J Med Sci. 2023;39(2):---------. doi: https://doi.org/10.12669/pjms.39.2.7428 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Research integrity in clinical trials: innocent errors and spin versus scientific misconduct

Cited by 14 publications

References 57 publications

International multi‐stakeholder consensus statement on clinical trial integrity

International multi‐stakeholder consensus statement on clinical trial integrity

Development of the Individual Participant Data (IPD) Integrity Tool for assessing the integrity of randomised trials using individual participant data

Systematic Review Reporting - Writing concisely and precisely

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