Search

Abstract Background Data-sharing policies in randomized clinical trials (RCTs) should have an evaluation component. The main objective of this case–control study was to assess the impact of published re-uses of RCT data in terms of media attention (Altmetric) and citation rates. Methods Re-uses of RCT data published up to December 2019 (cases) were searched for by two reviewers on 3 repositories (CSDR, YODA project, and Vivli) and matched to control papers published in the same journal. The Altmetric Attention Score (primary outcome), components of this score (e.g. mention of policy sources, media attention) and the total number of citations were compared between these two groups. Results 89 re-uses were identified: 48 (53.9%) secondary analyses, 34 (38.2%) meta-analyses, 4 (4.5%) methodological analyses and 3 (3.4%) re-analyses. The median (interquartile range) Altmetric Attention Scores were 5.9 (1.3—22.2) for re-use and 2.8 (0.3—12.3) for controls (p = 0.14). No statistical difference was found on any of the components of in the Altmetric Attention Score. The median (interquartile range) numbers of citations were 3 (1—8) for reuses and 4 (1 – 11.5) for controls (p = 0.30). Only 6/89 re-uses (6.7%) were cited in a policy source. Conclusions Using all available re-uses of RCT data to date from major data repositories, we were not able to demonstrate that re-uses attracted more attention than a matched sample of studies published in the same journals. Small average differences are still possible, as the sample size was limited. However matching choices have some limitations so results should be interpreted very cautiously. Also, citations by policy sources for re-uses were rare. Trial registration Registration: osf.io/fp62e

Abstract Objective To describe surgical journals’ position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion. Methods Only “SURGICAL” journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors (OIA) or if they had published randomised controlled trial (RCT) between 1 January 2016 and 31 December 2018. The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data-sharing policies were grouped into 3 categories, inclusion of data-sharing policy mandatory, optional, or not available. Details on research transparency promotion were also collected, namely the existence of a “prospective registration of clinical trials requirement policy”, a conflict of interests (COIs) disclosure requirement, and a specific reference to reporting guidelines, such as CONSORT for RCT. Results Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR = 2.48–3.77], and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR = 5–20.75]. The OIA of four journals (5%) stated that the inclusion of a data-sharing statement was mandatory, optional in 45% (n = 37), and not included in 50% (n = 41). No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A “prospective registration of clinical trials requirement” was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors. Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines. Conclusion Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.

Background: Research culture is strongly influenced by academic incentives and pressures such as the imperative to publish in academic journals, and can influence the nature and quality of the evidence we produce., Objective: The purpose of this rapid scoping review is to capture the breadth of differential pressures and contributors to current research culture, drawing together content from empirical research specific to the health and biomedical sciences., Study Design and Setting: PubMed and Web of Science were searched for empirical studies of influences and impacts on health and biomedical research culture, published between January 2012 and April 2024. Data charting extracted the key findings and relationships in research culture from included papers such as workforce composition; equitable access to research; academic journal trends, incentives, and reproducibility; erroneous research; questionable research practices; biases vested interests; and misconduct. A diverse author network was consulted to ensure content validity of the proposed framework of i) inclusivity, ii) transparency, iii) rigor, and iv) objectivity., Results: A growing field of studies examining research culture exists ranging from the inclusivity of the scientific workforce, the transparency of the data generated, the rigor of the methods used and the objectivity of the researchers involved. Figurative diagrams are presented to storyboard the links between research culture content and findings., Conclusion: The wide range of research culture influences in the recent literature indicates the need for coordinated and sustained research culture conversations. Core principles in effective research environments should include inclusive collaboration and diverse research workforces, rigorous methodological approaches, transparency, data sharing, and reflection on scientific objectivity., Competing Interests: Declaration of competing interest L.U. is an Editorial Board Member for the Journal of Clinical Epidemiology but was not involved in the editorial handling or peer review of this article. J.B. receives funding from the National Health and Medical Research Council (Ideas grant APP1184263 and APP2029249). M.M. is chair of the UK Reproducibility Network Supervisory Board. C.L. is funded by the ERC Synergy Grant NanoBubbles and has no conflicts of interest to declare. T.S. and L.M. have no conflicts of interest to declare. A.T. is funded by a Tier 1 Canada Research Chair in knowledge synthesis for knowledge users and is also coeditor of The Journal of Clinical Epidemiology but had no involvement with the processing of this paper or any decisions related to this paper. D.M. is on the editorial board of JCE and one of the guest editors on the ‘Methodological aspects of research integrity and culture’ series in JCE but had no involvement with the process or decision to publish. F.N. received funding from the French National Research Agency (ANR-17-CE36-0010), the French ministry of health, and the French ministry of research. He is a work-package leader in the OSIRIS project (Open Science to Increase Reproducibility in Science). The OSIRIS project has received funding from the European Union's Horizon Europe research and innovation program under grant agreement No. 101094725. He is a work-package leader for the doctoral network MSCA-DN SHARE-CTD (HORIZON-MSCA-2022-DN-01 101,120,360), funded by the EU. He is part of the Lown List of Industry-Independent Health Experts. There are no competing interests for any other author., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

This paper reviews the scientific evidence on new anti-amyloid monoclonal antibodies for treating Alzheimer's disease as a case study for improving scientific evidence communication. We introduce five guidelines condensed from the biomedical evidence literature but adapted to the short format of science communication in e.g., journal opinion pieces and newspaper articles. Given the major importance and recent confusion regarding the discussed drugs, with certain disagreements seen e.g., between FDA and EMA, the suggested guidelines may be useful to clinicians discussing with their patients and to scientists communicating the evidence in balance. More generally, we hope that the guidelines may help us to improve communication of scientific evidence on complex topics in opinion pieces in the scientific literature, in advocacy, and in media appearances.

Competing Interests: Competing interests: CV is a PhD student in the OSIRIS (Open Science to Increase Reproducibility in Science) project. The OSIRIS project has received funding from the European Union’s Horizon Europe research and innovation programme under the grant agreement number 101094725. SH has received funding from the European Union’s Horizon Europe programme, the German Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (BMUV) and the LMUExcellent. CP received funding from NIH (NIEHS R01ES0324702 and NIA RF1AG074372). NJD has received funding from the European Union’s Horizon Europe programme, also via the OSIRIS project, the Naji Foundation, the German Federal Ministry of Education and Research (BMBF) and the Fetzer Franklin Memorial Fund, and has been employed on grants from the Mohn-Westlake Foundation, Laura and John Arnold Foundation, Elsevier and the Good Thinking Society in the last 5 years. BT is compensated for consulting with Seed Health and Enzymetrics Biosciences on microbiome study design. FN received funding from the French National Research Agency (ANR-17-CE36-0010), the French Ministry of Health and the French Ministry of Research. He is a work package leader in the OSIRIS project. He is a work package leader for the doctoral network MSCA-DN SHARE-CTD (HORIZON-MSCA-2022-DN-01 101120360), funded by the EU. The work of JPAI has been supported by an unrestricted gift from Sue and Bob O’Donnell to Stanford University.

Guided by the FAIR principles (Findable, Accessible, Interoperable, Reusable), responsible data sharing requires well-organized, high-quality datasets. However, researchers often struggle with implementing Data Management and Sharing Plans (DMSPs) due to lack of knowledge on how to do this, time constraints, legal, technical and financial challenges, particularly concerning data ownership and privacy. While patients support data sharing, researchers and funders may hesitate, fearing the loss of intellectual property or competitive advantage. Although some journals and institutions encourage or mandate data sharing, further progress is needed. Additionally, global solutions are vital to ensure equitable participation from low- and middle-income countries. Ultimately, responsible data sharing requires strategic planning, cultural shifts in research, and coordinated efforts from all stakeholders to become standard practice in biomedical research., (Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: Relying on published data alone might be insufficient for meta-analyses to be reliable and trustworthy since selective outcome reporting is common, especially for adverse events. We investigated the existence of selective reporting and its potential for bias in a case study exploring adverse events of duloxetine in adults., Study Design and Setting: We systematically searched all previous meta-analyses/pooled analyses on duloxetine published on PubMed for 7 indications approved by the American and European health authorities. We included all randomized controlled trials (RCT) versus placebo. For each RCT, we extracted the number of serious adverse events (SAE), adverse events (AE), drop-outs (DO) and drop-outs for safety reasons (DOSR) using 4 information sources: published articles, clinical study registries, clinical study reports and data available in meta-analyses/pooled analyses. To assess the range of differences resulting from these 4 extraction strategies, we performed 4 meta-analyses using random effect models as well as a complete meta-analysis combining all sources., Results: 70 RCTs (including 24,330 patients) were included. Of those, SAEs were identified for 42 studies (61%) in published articles, 58 (84%) in study reports (8 study reports were not retrieved), 24 (34.7%) in registries, and 21 (30.4%) in meta-analyses/pooled analyses.For 2 (2.9%), 2 (2.9%), 2 (2.9%) and 1 (1.4%) studies, we found respectively no data on SAEs, AEs, DOs and DOSRs in any sources. Discrepant results across sources were found in 24 (34.5%), 20 (28.5%), 13 (18.6%) and 9 (12.8%) studies, respectively for SAEs, AEs, DOs and DOSRs. Despite variations in point estimates and their 95% confidence intervals, we did not find different results in the conclusions of meta-analyses depending on the different information sources used, except for DOs, for which no effect was found using results published in registries, in contrast to other information sources., Conclusion: None of the four information sources provided complete retrieval of safety results for duloxetine in adults across various indications. However, we did not find strong evidence that this under-reporting leads to different conclusions in meta-analyses. Nonetheless, this finding remains uncertain, as we were unable to obtain complete information for all studies despite extensive searches., (Copyright © 2025. Published by Elsevier Inc.)

Pain is a non-motor symptom that impairs quality of life in patients with Parkinson's disease. Pathological nociceptive hypersensitivity in patients could be due to changes in the processing of somatosensory information at the level of the basal ganglia, including the subthalamic nucleus (STN), but the underlying mechanisms are not yet defined. Here, we investigated the interaction between the STN and the dorsal horn of the spinal cord (DHSC), by first examining the nature of STN neurons that respond to peripheral nociceptive stimulation and the nature of their responses under normal and pathological conditions. Next, we studied the consequences of deep brain stimulation (DBS) of the STN on the electrical activity of DHSC neurons. Then, we investigated whether the therapeutic effect of STN-DBS would be mediated by the brainstem descending pathway involving the rostral ventromedial medulla. Finally, to better understand how the STN modulates allodynia, we used Designer Receptors Exclusively Activated by Designer Drugs (DREADDs) expressed in the STN. The study was carried out on the 6-OHDA rodent model of Parkinson's disease, obtained by stereotactic injection of the neurotoxin into the medial forebrain bundle of rats and mice. In these animals, we used motor and nociceptive behavioural tests, in vivo electrophysiology of STN and wide dynamic range (WDR) DHSC neurons in response to peripheral stimulation, deep brain stimulation of the STN and the selective DREADD approach. Vglut2-ires-cre mice were used to specifically target and inhibit STN glutamatergic neurons. STN neurons are able to detect nociceptive stimuli, encode their intensity and generate windup-like plasticity, like WDR neurons in the DHSC. These phenomena are impaired in dopamine-depleted animals, as the intensity response is altered in both spinal and subthalamic neurons. Furthermore, as with L-DOPA, STN-DBS in rats ameliorated 6-OHDA-induced allodynia, and this effect is mediated by descending brainstem projections leading to normalization of nociceptive integration in DHSC neurons. Furthermore, this therapeutic effect was reproduced by selective inhibition of STN glutamatergic neurons in Vglut2-ires-cre mice. Our study highlights the centrality of the STN in nociceptive circuits, its interaction with the DHSC and its key involvement in pain sensation in Parkinson's disease. Furthermore, our results provide for the first-time evidence that subthalamic DBS produces analgesia by normalizing the responses of spinal WDR neurons via descending brainstem pathways. These effects are due to direct inhibition, rather than activation of glutamatergic neurons in the STN or passage fibres, as shown in the DREADDs experiment., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Parkinson's disease arises from the degeneration of dopaminergic neurons in the substantia nigra pars compacta, leading to motor symptoms such as akinesia, rigidity, and tremor at rest. The non-motor component of Parkinson's disease includes increased neuropathic pain, the prevalence of which is 4 to 5 times higher than the general rate. By studying a mouse model of Parkinson's disease induced by 6-hydroxydopamine, we assessed the impact of dopamine depletion on pain modulation. Mice exhibited mechanical hypersensitivity associated with hyperexcitability of neurons in the dorsal horn of the spinal cord (DHSC). Serotonin (5-HT) levels increased in the spinal cord, correlating with reduced tyrosine hydroxylase (TH) immunoreactivity in the nucleus raphe magnus (NRM) and increased excitability of 5-HT neurons. Selective optogenetic inhibition of 5-HT neurons attenuated mechanical hypersensitivity and reduced DHSC hyperexcitability. In addition, the blockade of 5-HT 2A and 5-HT 3 receptors reduced mechanical hypersensitivity. These results reveal, for the first time, that PD-like dopamine depletion triggers spinal-mediated mechanical hypersensitivity, associated with serotonergic hyperactivity in the NRM, opening up new therapeutic avenues for Parkinson's disease-associated pain targeting the serotonergic systems., Competing Interests: Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

Studies with negative results are less likely to be published than others, potentially leading to publication bias. Introduced in 2000, trial registration could have participated in decreasing the proportion of unpublished studies. We assessed the proportion of negative randomized controlled trials (RCT) over the last 20 years. We searched Medline for RCT published in 2000, 2005, 2010, 2015, and 2020 in the British Medical Journal, the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine. The primary endpoint was the proportion of negative (final comparison on the primary study-endpoint without statistical significance or favoring the control arm) studies published in 2000 and 2020. Factors independently associated with the publication of negative studies were identified using multivariable analysis. A total of 1,542 studies were included. The proportion of negative RCT significantly increased between 2000 and 2020 (from 27.6% to 37.4%; P = 0.01), however, the trend over time was not significant (P = 0.203). In multivariable analysis, the following factors were associated with a higher proportion of published negative studies: superiority (P < 0.001), two-group trials (P < 0.001), number of patients ≥510 (P < 0.001), cardiology trials (P = 0.003), emergency/critical care trials (P < 0.001), obstetrics trials (P = 0.032), surgery trials (P = 0.006), pneumology trials (P = 0.029). Exclusive industry funding was associated with a lower proportion of published negative studies (P < 0.001). The proportion of published negative studies in 2020 was higher only when compared to 2000. During the two decades, no trend was noticeable. There is no clear relationship between trial registration and the publication of negative results over time., (© 2025 The Author(s). Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Public engagement with reproducibility is crucial for fostering trust in science. This Community Page outlines, through the example of baking Christmas tree meringues, how scientists can effectively engage and educate the public about the importance of reproducibility in research., Competing Interests: FN received funding from the French National Research Agency, the French ministry of health and the French ministry of research. He is a work package leader in the OSIRIS project (Open Science to Increase Reproducibility in Science), as are IS, VE and HR. CV and MK are also PhD student in this project. FN is also work package leader for the doctoral network MSCA-DN SHARE-CTD (HORIZON-MSCA-2022-DN-01 101120360), funded by the EU. LC has no conflict of interests to disclose., (Copyright: © 2024 Vinatier et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The issue of assessing the effectiveness of health technologies (drugs, devices, etc.) through observational studies is becoming increasingly important as registration and market access agencies consider them in their evaluation process. In this context, observational studies must be able to provide real demonstrations of a level of reliability comparable to those produced by the conventional randomized controlled trial (RCT) approach. The objective of the roundtable was to establish the acceptability criteria for an observational study (non-randomized, non-interventional study) to be able to provide these demonstrations, and possibly serve as a confirmatory study for registration and market access authorities, the construction of therapeutic strategies or the development of recommendations. In order to do this, the study must be a real confirmatory study respecting the hypothetical-deductive approach and guaranteeing the absence of HARKing and p-hacking by attesting to the establishment of a protocol and a statistical analysis plan, recorded before any inferential analysis. It must also be part of a formalized approach to causal inference and demonstrate that it correctly identifies the causal estimand sought. The study should ensure that there is no residual confusion bias by taking into account all confounding factors affecting the comparison, which should be determined by a formal approach (such as a graphical causality approach, DAGs). Residual confusion bias diagnoses by forgery and nullification analysis should be non-existent. The study shall be at low risk of bias, in particular selection bias, among others by using a target test emulation design. Overall type I error risk should be strictly controlled. The absence of selective publication of results and selection bias should be ensured., (Copyright © 2024 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declarations of interests and have the following interests to declare: FN received funding from the French National Research Agency (ANR-17-CE36-0010), the French ministry of health and the French ministry of research. He is a work package leader in the OSIRIS project (Open Science to Increase Reproducibility in Science), which has received funding from the EU’s Horizon Europe research and innovation programme. He is a work-package leader for the doctoral network MSCA DN SHARE-CTD (HORIZON-MSCA-2022-DN-01 101120360), funded by the EU.

Objectives: To evaluate whether there is evidence of efficacy of the most commonly used medications in their primary indications., Study Design and Setting: This scoping review was executed using the Cochrane Library and MEDLINE databases up to May 2023. The 10 most prescribed medications in England, France, and the United States were identified using country-specific public databases. Up to 3 common indications in primary care were defined for each medication, based on a survey of general practitioners. The outcomes were determined by the authors to be patient-important outcomes, with placebo as the comparator. Two investigators independently conducted searches, following a predefined algorithm, to identify randomized controlled trials or meta-analyses of randomized controlled trials assessing the efficacy of these medications for each indication. The risk of bias was assessed using the ROBIS or ROB 2.0 tools., Results: We identified 21 drugs, covering 56 indications and 114 outcomes. Sixty-seven percent of the evaluated medications demonstrated efficacy for at least one outcome in at least one of the sought indications. Overall, evidence of efficacy was found for 48% of the indications. There was no study evaluating the efficacy of amoxicillin and salbutamol. For other drugs such as phloroglucinol or cholecalciferol, available studies suggested an absence of efficacy in the most common indications., Conclusion: This study underscores the lack of data regarding the level of evidence for the most prescribed medications. Limitations include the choice of outcomes, and the understanding that the absence of evidence is not synonymous with the absence of efficacy., Competing Interests: Declaration of competing interest All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/and declare: no support from any organization for the submitted work, no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Methodological limitations affect a significant number of oncology and haematology trials, raising concerns about the applicability of their results. For example, a suboptimal control arm or limited access to best care upon progression may skew the trial results toward a benefit in the experimental arm. Beyond the fact that such limitations do not prevent drugs reaching the market, other assessment tools, such as those developed by professional societies-ESMO-MCBS and ASCO Value Framework-do not integrate these important shortcomings., Methods: We propose creating a novel framework with the scope of assessing registration cancer clinical trials in haematology and oncology (randomized or single arm)-that is trials leading to a marketing authorization. The main steps of the methods are (1) assembling a scientific board; (2) defining the scope, goal and methods through pre-specified, pre-registered and protocolized methodology; (3) preregistration of the protocol; (4) conducting a scoping review of limitations and biases affecting oncology trials and assessing existing scores or methods; (5) developing a list of features to be included and assessed within the framework; (6) assessing each feature through a questionnaire sent to highly cited haematologists and oncologists involved in clinical trials; and (7) finalizing the first version of framework., Results: Not applicable., Conclusions: Our proposal emerged in response to the lack of consideration for key limitations in current trial assessments. The goal is to create a framework specifically designed to assess single trials leading to marketing authorization in the field of oncology and haematogy., (© 2024 The Author(s). European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.)

Objective: It is frequent to find overlapping network meta-analyses (NMAs) on the same topic with differences in terms of both treatments included and effect estimates. We aimed to evaluate the impact on effect estimates of selecting different treatment combinations (ie, network geometries) for inclusion in NMAs., Design: Multiverse analysis, covering all possible NMAs on different combinations of treatments., Setting: Data from a previously published NMA exploring the comparative effectiveness of 22 treatments (21 antidepressants and a placebo) for the treatment of acute major depressive disorder., Participants: Cipriani et al explored a dataset of 116 477 patients included in 522 randomised controlled trials., Main Outcome Measures: For each possible treatment selection, we performed an NMA to estimate comparative effectiveness on treatment response and treatment discontinuation for the treatments included (231 between-treatment comparisons). The distribution of effect estimates of between-treatment comparisons across NMAs was computed, and the direction, magnitude and statistical significance of the 1st and 99th percentiles were compared., Results: 4 116 254 different NMAs concerned treatment response. Among possible network geometries, 172/231 (74%) pairwise comparisons exhibited opposite effects between the 1st and 99th percentiles, 57/231 (25%) comparisons exhibited statistically significant results in opposite directions, 118 of 231 (51%) comparisons derived results that were both significant and non-significant at 5% risk and 56/231 (24%) treatment pairs obtained consistent results with only significant differences (or only non-significant differences) at 5% risk. Comparisons based on indirect evidence only were associated with greater variability in effect estimates. Comparisons with small absolute values observed in the complete NMA more frequently obtained statistically significant results in opposite directions. Similar results were observed for treatment discontinuation., Conclusion: In this multiverse analysis, we observed that the selection of treatments to be included in an NMA could have considerable consequences on treatment effect estimations., Trial Registration: https://osf.io/mb5dy., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare that FN received funding from the French National Research Agency (ANR-17-CE36-0010), the French ministry of health, and the French ministry of research. He is a work package leader in the OSIRIS project (Open Science to Increase Reproducibility in Science). The OSIRIS project has received funding from the European Union’s Horizon Europe research and innovation program under the grant agreement No. 101094725. He is a work package leader for the doctoral network MSCA-DN SHARE-CTD funded by the EU. Provenance and peer review: Not commissioned; externally peer reviewed.

Objectives: To explore the association between industry funding and network meta-analyses' (NMAs) conclusion, and the use in Clinical Practice Guidelines (CPGs) of NMAs., Study Design and Setting: This was an overview of NMAs and CPGs. We searched PubMed/MEDLINE, Epistemonikos, and several guideline databases up to February 18th 2023. We included CPGs from the last 5 years and NMAs of randomized controlled trials that evaluated targeted therapies in immune-mediated inflammatory diseases. Data extraction and outcome assessments were done in duplicate by independent authors., Results: We included 216 NMAs and 99 CPGs. 31% (67/216) were industry-funded. The proportion of industry-funded NMAs that cited one treatment as being best was 44% (25/57) compared to 26% (30/116) for nonindustry-funded (OR = 2.24 [1.15-4.39]; aOR = 1.76 [0.81-3.81]). The abstract's conclusion of 39/67 (58%) industry-funded and 69/149 (46%) nonindustry-funded NMAs were considered unsupported by the results (OR = 1.61 [0.90-2.89]; aOR = 1.40 [0.71-2.78]). All industry-funded NMAs that cited one treatment as best cited their own sponsored drug. 59/99 (60%) CPGs included at least one NMA, with 23/59 (39%) of them citing industry-funded NMAs., Conclusions: We did not find evidence that industry-funded NMAs were more likely to have unsupported conclusions or to cite only one treatment as being best in their conclusions compared to non-industry-funded NMAs. However, almost all industry-funded NMAs favored their own treatments. Even though 40% of the CPGs did not rely on NMA, over a third of those who did used industry-funded NMAs. Limitations include the possible misclassification due to undisclosed funding and potential confounders that have not been accounted for., Competing Interests: Declaration of competing interest Robin Guelimi reports financial support was provided by Public Assistance Hospitals Paris. and the Association for Interdisciplinary Meta-Research and Open Science. LLC, ES, and SA are co-authors of this work and authors of several studies that are included in the submitted overview. L.L.C., E.S., and S.A. are authors of several studies that are included in this overview. L.L.C. took part in the selection process, but none of them were involved in the extraction of data or in the assessment of the quality of a work they took a part in. L.L.C. and E.S. received a grant from the French Ministry of Health (PHRC-N AOM22145). L.L.C. is the co-ordinating editor of the Cochrane Skin. F.N. received funding from the French National Research Agency (ANR-17-CE36-0010), the French ministry of health and the French ministry of research. He is a work package leader in the OSIRIS project (Open Science to Increase Reproducibility in Science). The OSIRIS project has received funding from the European Union's Horizon Europe research and innovation programme under the grant agreement No. 101094725. He is a work package leader for the doctoral network MSCA-DN SHARE-CTD (HORIZON-MSCA-2022-DN-01 101120360) funded by the EU. YZZN received a grant from the NIHR Manchester Biomedical Research Centre (NIHR203308). R.G., A.M., T.B., and G.P. had no conflict of interest to declare. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Many interventions, especially those linked to open science, have been proposed to improve reproducibility in science. To what extent these propositions are based on scientific evidence from empirical evaluations is not clear., Aims: The primary objective is to identify Open Science interventions that have been formally investigated regarding their influence on reproducibility and replicability. A secondary objective is to list any facilitators or barriers reported and to identify gaps in the evidence., Methods: We will search broadly by using electronic bibliographic databases, broad internet search, and contacting experts in the field of reproducibility, replicability, and open science. Any study investigating interventions for their influence on the reproducibility and replicability of research will be selected, including those studies additionally investigating drivers and barriers to the implementation and effectiveness of interventions. Studies will first be selected by title and abstract (if available) and then by reading the full text by at least two independent reviewers. We will analyze existing scientific evidence using scoping review and evidence gap mapping methodologies., Results: The results will be presented in interactive evidence maps, summarized in a narrative synthesis, and serve as input for subsequent research., Review Registration: This protocol has been pre-registered on OSF under doi https://doi.org/10.17605/OSF.IO/D65YS., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Dudda LA et al.)

Background: The dissemination of clinical trial results is an important scientific and ethical endeavour. This survey of completed interventional studies in a French academic center describes their reporting status., Methods: We explored all interventional studies sponsored by Rennes University Hospital identified on the French Open Science Monitor which tracks trials registered on EUCTR or clinicaltrials.gov, and provides an automatic assessment of the reporting of results. For each study, we ascertained the actual reporting of results using systematic searches on the hospital internal database, bibliographic databases (Google Scholar, PubMed), and by contacting all principal investigators (PIs). We describe several features (including total budget and numbers of trial participants) of the studies that did not report any results., Results: The French Open Science Monitor identified 93 interventional studies, among which 10 (11%) reported results. In contrast, our survey identified 36 studies (39%) reporting primary analysis results and an additional 18 (19%) reporting results for secondary analyses (without results for their primary analysis). The overall budget for studies that did not report any results was estimated to be €5,051,253 for a total of 6,735 trial participants. The most frequent reasons for the absence of results reported by PIs were lack of time for 18 (42%), and logistic difficulties (e.g. delay in obtaining results or another blocking factor) for 12 (28%). An association was found between non-publication and negative results (adjusted Odds Ratio = 4.70, 95% Confidence Interval [1.67;14.11])., Conclusions: Even allowing for the fact that automatic searches underestimate the number of studies with published results, the level of reporting was disappointingly low. This amounts to a waste of trial participants' implication and money. Corrective actions are needed., Trial Registration: https://osf.io/q5hcs., (© 2024. The Author(s).)

Competing Interests: Competing interests: DC reports an HIV grant from Janssen (2019-2020), personal fees from Gilead (2020) and Pfizer (2022) for lectures outside the submitted work. RT has been the coordinator of the IMI2 EBOVAC2 project in collaboration with Janssen (2014-2021). Other authors have no competing interests to disclose.

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and have the following interests to declare: FN received funding from the French National Research Agency (ANR-17-CE36-0010), the French Ministry of Health and the French Ministry of Research. He is a work package leader in the OSIRIS project (Open Science to Increase Reproducibility in Science), which has received funding from the European Union’s Horizon Europe research and innovation programme under the grant agreement No. 101094725. He is a work package leader for the doctoral network MSCA-DN SHARE-CTD (HORIZON-MSCA-2022-DN-01 101120360), funded by the EU. CJP received funding from National Institutes for Health (NIEHS R01ES0324702 and NIA RF1AG074372). NJD has received funding from the Horizon Europe programme, the OSIRIS project, the Naji Foundation, the German Federal Ministry of Education and Research, and the Fetzer Franklin Memorial Fund and has been employed on grants from the Mohn-Westlake Foundation, Laura and John Arnold Foundation, Elsevier, and the Good Thinking Society in the past five years. SH has received funding from Horizon Europe, the German Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection, and from LMUExcellent.

Objective: To explore differences between published reviews and their respective protocols in a sample of 97 non-Cochrane Systematic Reviews (non-CSRs) and 97 Cochrane Systematic Reviews (CSRs) in terms of PICOS (Patients/Population, Intervention, Comparison/Control, Outcome, Study type) elements and the extent to which they were reported., Study Design and Setting: We searched PubMed and Cochrane databases to identify non-CSRs and CSRs that were published in 2018. We then searched for their corresponding Cochrane or PROSPERO protocols. The published reviews were compared to their protocols. The primary outcome was changes from protocol to review in terms of PICOS elements., Results: We identified a total of 227 changes from protocol to review in PICOS elements, 1.11 (Standard Deviation (SD), 1.22) changes per review for CSRs and 1.23 (SD, 1.12) for non-CSRs per review. More than half of each sub-sample (54.6% of CSRs and 67.0% of non-CSRs) (Absolute Risk Reduction (ARR) 12.4% [-1.3%; 26.0%]) had changes in PICOS elements. For both subsamples, approximately a third of all changes corresponded to changes related to primary outcomes. Marked differences were found between the sub-samples for the reporting of changes. 95.8% of the changes in PICOS items were not reported in the non-CSRs compared to 42.6% in the CSRs (ARR 53.2% [43.2%; 63.2%])., Conclusion: CSRs showed better results than non-CSRs in terms of the reporting of changes. Reporting of changes from protocol needs to be promoted and requires general improvement. The limitations of this study lie in its observational design. Registration: https://osf.io/6j8gd/., Competing Interests: Marta Roqué, Roberto Acosta-Dighero & Meisser Madera are members of Cochrane. Maximilian Siebert did a 2-month internship at the Iberoamerican Cochrane Center in 2019., (©2023 Siebert et al.)

Competing Interests: Declaration of competing interest None declared. The Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) is supported by the Foundation Clinical Neuroimmunology and Neuroscience Basel (Switzerland).

Objectives: This descriptive study of registered trials aimed to identify large clinical trials on antidepressants for mental disorders: (1) to assess what proportion could be labelled as 'seeding trials' (trials for marketing purposes) and (2) to describe their methodological characteristics and outcomes., Design: A search was conducted across all trials registered on ClinicalTrials.gov by drug name in March 2017., Setting: All trials registered in the database of ClinicalTrials.gov were screened. Large registered studies were received and studies focusing prospectively on the effects of antidepressants in mental health disorders. Specific data items were extracted automatically, and subsequently inspected, corrected and completed by hand., Participants: Prospective studies were selected focusing on the effects of antidepressants in any mental health disorder with 800 participants or more planned for inclusion., Main Outcome Measures: Three members from the study team independently assessed the following 'seeding trial' characteristics in each registered study: a high level of involvement of the product manufacturer in the study design, in the data analysis and reporting of the study, an abnormally low ratio of patient numbers to study site, spin and/or omissions of clinically relevant findings in the abstracts, and conclusions that focused on secondary endpoints and surrogate markers. Secondary outcomes were the exploration of a functional outcome and suicidality., Results: 31 trials were identified from clinical trials database. 18/31 were published (58%). 8 of these 18 (44%) studies were identified as possible seeding trials. 13/31 (42%) large trials planned to explore functioning and 5/31 (16%) suicidality., Conclusions: Large trials are rare in the field of antidepressant research. Some could be 'seeding trials'. Few explored suicidality. Identifying seeding trials from incomplete data entries in registries, especially when almost half of the studies were still unpublished, posed considerable challenges. The delay between our research and publication limits the strength of our conclusions., Prospero Registration Number: CRD42017065591., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Declaration of competing interest The authors declare that they have no competing interests.

Objective: Registered reports (RR) are a publication format implying a peer-review of the protocol before the start of the study, followed by an in-principle acceptance (IPA) by the journal before the study starts. We aimed to describe randomized controlled trials (RCTs) in the clinical field published as RR., Study Design and Setting: This cross-sectional study included RR results for RCTs, identified on PubMed/Medline and on a list compiled by the Center for Open Science. It explored the proportion of reports that received IPA (and/or published a protocol before inclusion of the first patient) and changes in the primary outcome., Results: A total of 93 RCTs publications identified as RR were included. All but one were published in the same journal group. The date of the IPA was never documented. For most of these reports (79/93, 84.9%), a protocol was published after the date of inclusion of the first patient. A change in the primary outcome was noted in 40/93 (44%) of them. Thirteen of the 40 (33%) mentioned this change., Conclusions: RCTs in the clinical field identified as RR were rare, originated from a single journal group, and did not comply with the basic features of this format., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2023. Published by Elsevier Inc.)

Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Clinical trials and randomised clinical trials (RCTs) are the best method to evaluate drug efficacy and side effects. In a shared medical decision-making approach, general practitioners need drug assessment based on patient-important outcomes. The aim of project rebuild the evidence base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome: 1) a meta-analysis based on RCTs with a low risk of bias overall; 2) an evaluation of results of confirmatory RCTs; 3) a statistical analysis of heterrogeneity between RCTs and 4) an analysis of publication bias. Depending on the results of these analyses, the evidence will be categorized in 4 different levels: firm evidence, evidence (to be confirmed), signal or absence of evidence. Project REB proposes a method for reading and interpreting RCTs and their meta-analysis to produce quality data for general practitioners to focus on risk-benefit assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim., (Copyright © 2022 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirementsRule 2: Anticipate the possibility of clinical trial data-sharing before obtaining fundingRule 3: Declare your intent to share data in the registration stepRule 4: Involve research participantsRule 5: Determine the method of data accessRule 6: Remember there are several other elements to shareRule 7: Do not proceed aloneRule 8: Deploy optimal data management to ensure that the data shared is usefulRule 9: Minimize risksRule 10: Strive for excellence., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Pellen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)