What to write
Sources of funding and other support (eg, supply of drugs), and role of funders in the design, conduct, analysis, and reporting of the trial
Examples
“Grant support was received for the intervention from Plan International and for the research from the Wellcome Trust and Joint United Nations Programme on HIV/AIDS (UNAIDS). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”1
“Funding: Merck Sharp and Dohme . . . The study funder had a role in the study design, data collection, data analysis, data interpretation, and writing of the report.”2
The article also states that “Merck employees LY, SB, and PB were involved in the conceptualisation of the study, formal analysis, the investigation process, development of the methodology, project administration, drafting the manuscript, and had critically reviewed and edited the manuscript.”2
Explanation
Reporting the funding source(s), and the exact roles of the trial funders, provides important context for readers of a trial report when ascertaining overall methodological rigor (eg, relevance of the type of comparator intervention and eligibility criteria for patients) and risk of bias (eg, selective reporting of favourable results). The trial report should therefore describe details of all funders and the types of funding, as well as the role of the funder in trial design (ie, protocol development), conduct, data analysis, and reporting (ie, interpretation, manuscript writing, and dissemination of results). This should include whether the funder controlled the final decision regarding any of these aspects of the trial, and any mechanisms introduced to minimise funder influence. If the funder had no direct involvement in the trial, that should be stated.
A randomised trial requires considerable funding, typically from pharmaceutical or device companies (industry funding); or from research councils or other scientific or private foundations, or governmental or non-governmental organisations (non-industry funding).3 One study of trials conducted between 2010 and 2015 estimated the median cost per phase 3 drug company trial at $21.4m (£17.21m; €20.7m),4 with substantial variation. The mean cost of clinical trials funded by the NIHR in the UK, reflecting differences in the research and care infrastructure already funded, was lower, but still sizeable—approximately £1.3m—with considerable variation.5 The various types of funders differ in their overall agenda, their reasons for funding a trial, and their propensity to influence the trial.
Funding of a trial typically involves direct monetary support, but financial support may also be provided indirectly in the form of free trial drugs, equipment, or services (eg, statistical analysis or use of medical writers).6 Among the most highly cited clinical trials published in 2019 to 2022, two thirds were funded by industry sponsors, many of whom also provided industry analysts and coauthors.7
Industry funding of trials is associated with conclusions that favour the experimental intervention. A systematic review of 75 methodological studies, comparing industry funded studies with non-industry funded studies (mostly randomised trials), reported that industry funded studies had favourable conclusions more often than non‐industry funded studies (risk ratio 1.34; 95% confidence interval (CI) 1.19 to 1.51).8 Industry funded trials may also report more favourable results (ie, larger estimates of intervention effects) than comparable trials that are funded by non-industry sources. One review of eight published meta-epidemiological studies reported that intervention effects (odds ratios) from industry funded trials were, on average, exaggerated by 5% (95% CI −6% to 15%), although the result was imprecise and consistent with chance findings. However, trials with a high risk of industry funder influence (eg, on trial design, conduct, analysis, and reporting) exaggerated effect estimates by 12% (95% CI 3% to 19%).9 Undue influence on trials from non-industry funders with a strong interest in a specific trial result has been described,10 but has been studied much less.
A review of 200 trials published in 201511 found that 178 (89%) publications included a funding statement. However, in half of the publications, the role of funder was not reported; in the other half, the reporting was often unclear or incomplete; and undisclosed funding from a for-profit organisation was found in 26 of 54 trials reporting only not-for-profit funding. Another study surveyed authors of 200 trials fully funded by industry and found that funders had been involved in the design of 173 trials (87%), in the data analysis of 146 trials (73%), and in the reporting of 173 trials (87%).6 No clear consensus exists on a monetary threshold for when funding from a source with conflict of interest becomes problematic. It is also unclear whether commercial funding is less important than the degree and type of funder influence on trial design, conduct, analysis, and reporting.
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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