Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance.
Maram B Hakoum, Nahla Jouni, Eliane A Abou-Jaoude, Divina Justina Hasbani, Elias A Abou-Jaoude, Luciane Cruz Lopes, Mariam Khaldieh, Mira Zein Hammoud, Mounir Al-Gibbawi, Sirine Anouti, Gordon Guyatt, Elie A Akl
Author Information
Maram B Hakoum: Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon. ORCID
Nahla Jouni: Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut, Lebanon.
Eliane A Abou-Jaoude: Department of Internal Medicine, University at Buffalo - The State University of New York, Buffalo, New York, USA.
Divina Justina Hasbani: Faculty of Medicine, American University of Beirut, Beirut, Lebanon.
Elias A Abou-Jaoude: The State University of New York, Buffalo, New York, USA.
Luciane Cruz Lopes: Graduate Program in Pharmaceutical Sciences, University of Sorocaba, Brazil, Sorocaba, São Paulo, Brazil. ORCID
Mariam Khaldieh: Faculty of Sciences, American University of Beirut, Beirut, Lebanon.
Mira Zein Hammoud: Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.
Mounir Al-Gibbawi: Faculty of Medicine, American University of Beirut, Beirut, Lebanon.
Sirine Anouti: Department of Epidemiology and Population Health, American University of Beirut, Beirut, Lebanon.
Gordon Guyatt: Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Elie A Akl: Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon.
OBJECTIVES: To provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information. METHODS: We addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information. RESULTS: Of 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information. CONCLUSION: Although the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for-profit organisations.
