Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance

Hakoum, Maram B; Jouni, Nahla; Abou-Jaoude, Eliane; Hasbani, Divina Justina; Abou-Jaoude, Elias A.; Lopes, Luciane Cruz; Khaldieh, Mariam; Hammoud, Mira Z.; Al-Gibbawi, Mounir; Anouti, Sirine; Guyatt, Gordon; Akl, Elie A.

doi:10.1136/bmjopen-2017-015997

Cited by 51 publications

(40 citation statements)

References 55 publications

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“…HPSR papers do not compare favourably with clinical papers in terms of the reporting of funding. Recently, we found that 89% of clinical trial reports published in 2015 included funding statements [ 16 ], a percentage substantively higher than the 69% found for HPSR papers herein. In addition, we found that 50% of the clinical trials described as funded reported on the role of funders, a much higher percentage than the 11% found for HPSR papers herein [ 16 ].…”

Section: Discussioncontrasting

confidence: 60%

The reporting of funding in health policy and systems research: a cross-sectional study

Khamis

Bou-Karroum

Hakoum

et al. 2018

Health Res Policy Sys

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BackgroundMajor research-reporting statements, such as PRISMA and CONSORT, require authors to provide information about funding. The objectives of this study were (1) to assess the reporting of funding in health policy and systems research (HPSR) papers and (2) to assess the funding reporting policies of journals publishing on HPSR.MethodsWe conducted two cross-sectional surveys for papers published in 2016 addressing HPSR (both primary studies and systematic reviews) and for journals publishing on HPSR (both journals under the ‘Health Policy and Services’ (HPS) category in the Web of Science, and non-HPS journals that published on HPSR). Teams of two reviewers selected studies and abstracted data in duplicate and independently. We conducted descriptive analyses and a regression analysis to investigate the association between reporting of funding by papers and the journal’s characteristics.ResultsWe included 400 studies (200 systematic reviews and 200 primary studies) that were published in 198 journals. Approximately one-third (31%) of HPSR papers did not report on funding. Of those that did, only 11% reported on the role of funders (15% of systematic reviews and 7% of primary studies). Of the 198 journals publishing on HPSR, 89% required reporting of the source of funding. Of those that did, about one-third (34%) required reporting of the role of funders. Journals classified under the HPS category (n = 72) were less likely than non-HPS journals that published HPSR studies (n = 142) to require information on the role of funders (15% vs. 32%). We did not find any of the journals’ characteristics to be associated with the reporting of funding by papers.ConclusionsDespite the majority of journals publishing on HPSR requiring the reporting of funding, approximately one-third of HPSR papers did not report on the funding source. Moreover, few journals publishing on HPSR required the reporting of the role of funders, and few HPSR papers reported on that role.

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Section: Discussioncontrasting

confidence: 60%

The reporting of funding in health policy and systems research: a cross-sectional study

Khamis

Bou-Karroum

Hakoum

et al. 2018

Health Res Policy Sys

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“…However, it often remains unclear in published papers whether industry sponsors have exerted a catalytic, modest, or no influence on the paper. CONSORT requires reporting of funding sources and conflicts of interest [ 14 ], but reporting remains suboptimal [ 15 ]. There is even less transparency on industry-led ghostwriting of the published reports [ 16 ].…”

Section: Introductionmentioning

confidence: 99%

Industry-funded versus non-profit-funded critical care research: a meta-epidemiological overview

2018

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PurposeTo study the landscape of funding in intensive care research and assess whether the reported outcomes of industry-funded randomized controlled trials (RCTs) are more favorable.MethodsWe systematically assembled meta-analyses evaluating any type of intervention in the critical care setting and reporting the source of funding for each included RCT. Furthermore, when the intervention was a drug or biologic, we searched also the original RCT articles, when their funding information was unavailable in the meta-analysis. We then qualitatively summarized the sources of funding. For binary outcomes, separate summary odds ratios were calculated for trials with and without industry funding. We then calculated the ratio of odds ratios (RORs) and the summary ROR (sROR) across topics. ROR < 1 implies that the experimental intervention is relatively more favorable in trials with industry funding compared with trials without industry funding. For RCTs included in the ROR analysis, we also examined the conclusions of their abstract.ResultsAcross 67 topics with 568 RCTs, 88 were funded by industry and another 73 had both industry and non-profit funding. Across 33 topics with binary outcomes, the sROR was 1.10 [95% CI (0.96–1.26), I2 = 1%]. Conclusions were not significantly more commonly unfavorable for the experimental arm interventions in industry-funded trials (21.3%) compared with trials without industry funding (18.2%).ConclusionIndustry-funded RCTs are the minority in intensive care. We found no evidence that industry-funded trials in intensive care yield more favorable results or are less likely to reach unfavorable conclusions.Electronic supplementary materialThe online version of this article (10.1007/s00134-018-5325-3) contains supplementary material, which is available to authorized users.

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“…Sponsors are the only ones that have full access to the study information. Although papers are presented and authored by independent investigators, statistical analyses are performed by Pharma personnel and manuscripts are prepared by medical writers 26 .…”

Section: Lack Of Transparency In the Planning And Execution Of The Stmentioning

confidence: 99%

III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

Aguilar-Salinas

Pascual‐Ramos

Sierra‐Madero

et al. 2020

RIC

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Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects' first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies. (REV INVEST

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Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance

Cited by 51 publications

References 55 publications

The reporting of funding in health policy and systems research: a cross-sectional study

The reporting of funding in health policy and systems research: a cross-sectional study

Industry-funded versus non-profit-funded critical care research: a meta-epidemiological overview

III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

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