Peer review before trial conduct could increase research value and reduce waste

Siebert, Maximilian; Naudet, Florian; Ioannidis, John P. A.

doi:10.1016/j.jclinepi.2023.05.024

Cited by 2 publications

(2 citation statements)

References 24 publications

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“…6 Moreover, empirical studies have shown the increasing use of full protocols and of statistical analysis plans. 20 Among publications in the most influential medical journals, mean availability of these items has surpassed 80% for protocols and 50% for analysis plans. 3 However, it is uncommon to find a priori registered versions of these documents, 3 and unexplained discrepancies in the statistical methods are common.…”

Section: Discussionmentioning

confidence: 99%

“…Data sharing statements have become highly popular and are routinely used, especially by journals that are likely to publish influential clinical research . Moreover, empirical studies have shown the increasing use of full protocols and of statistical analysis plans . Among publications in the most influential medical journals, mean availability of these items has surpassed 80% for protocols and 50% for analysis plans .…”

Section: Discussionmentioning

confidence: 99%

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Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

Siena,

Papamanolis,

Siebert

et al. 2023

JAMA Netw Open

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ImportanceIndustry involvement is prominent in influential clinical trials, and commitments to transparency of trials are highly variable.ObjectiveTo evaluate the modes of industry involvement and the transparency features of the most cited recent clinical trials across medicine.Design, Setting, and ParticipantsThis cross-sectional study was a meta-research assessment including randomized and nonrandomized clinical trials published in 2019 or later. The 600 trials of any type of disease or setting that attracted highest number of citations in Scopus as of December 2022 were selected for analysis. Data were analyzed from March to September 2023.Main Outcomes and MeasuresOutcomes of interest were industry involvement (sponsor, author, and analyst) and transparency (protocols, statistical analysis plans, and data and code availability).ResultsAmong 600 trials with a median (IQR) sample size of 415 (124-1046) participants assessed, 409 (68.2%) had industry funding and 303 (50.5%) were exclusively industry-funded. A total of 354 trials (59.0%) had industry authors, with 280 trials (46.6%) involving industry analysts and 125 trials (20.8%) analyzed exclusively by industry analysts. Among industry-funded trials, 364 (89.0%) reached conclusions favoring the sponsor. Most trials (478 trials [79.7%]) provided a data availability statement, and most indicated intention to share the data, but only 16 trials (2.7%) had data already readily available to others. More than three-quarters of trials had full protocols (482 trials [82.0%]) or statistical analysis plans (446 trials [74.3%]) available, but only 27 trials (4.5%) explicitly mentioned sharing analysis code (8 readily available; 19 on request). Randomized trials were more likely than nonrandomized studies to involve only industry analysts (107 trials [22.9%] vs 18 trials [13.6%]; P = .02) and to have full protocols (405 studies [86.5%] vs 87 studies [65.9%]; P &lt; .001) and statistical analysis plans (373 studies [79.7%] vs 73 studies [55.3%]; P &lt; .001) available. Almost all nonrandomized industry-funded studies (90 of 92 studies [97.8%]) favored the sponsor. Among industry-funded trials, exclusive industry funding (odds ratio, 2.9; 95% CI, 1.5-5.4) and industry-affiliated authors (odds ratio, 2.9; 95% CI, 1.5-5.6) were associated with favorable conclusions for the sponsor.Conclusions and RelevanceThis cross-sectional study illustrates how industry involvement in the most influential clinical trials was prominent not only for funding, but also authorship and provision of analysts and was associated with conclusions favoring the sponsor. While most influential trials reported that they planned to share data and make both protocols and statistical analysis plans available, raw data and code were rarely readily available.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

Siena,

Papamanolis,

Siebert

et al. 2023

JAMA Netw Open

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Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

Baba,

Smith,

Potter

et al. 2024

Trials

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Background Despite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C). Methods The development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to “lock” the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12–24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations. Discussion SPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste. Trial Registration The development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35) and CONSORT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD).

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Peer review before trial conduct could increase research value and reduce waste

Cited by 2 publications

References 24 publications

Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

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