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Research methods
Research
Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance
  1. Maram B Hakoum1,
  2. Nahla Jouni2,
  3. Eliane A Abou-Jaoude3,
  4. Divina Justina Hasbani4,
  5. Elias A Abou-Jaoude5,
  6. Luciane Cruz Lopes6,
  7. Mariam Khaldieh7,
  8. Mira Zein Hammoud8,
  9. Mounir Al-Gibbawi4,
  10. Sirine Anouti9,
  11. Gordon Guyatt10,
  12. Elie A Akl1,10,11
  1. 1 Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon
  2. 2 Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut, Lebanon
  3. 3 Department of Internal Medicine, University at Buffalo - The State University of New York, Buffalo, New York, USA
  4. 4 Faculty of Medicine, American University of Beirut, Beirut, Lebanon
  5. 5 The State University of New York, Buffalo, New York, USA
  6. 6 Graduate Program in Pharmaceutical Sciences, University of Sorocaba, Brazil, Sorocaba, São Paulo, Brazil
  7. 7 Faculty of Sciences, American University of Beirut, Beirut, Lebanon
  8. 8 Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA
  9. 9 Department of Epidemiology and Population Health, American University of Beirut, Beirut, Lebanon
  10. 10 Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  11. 11 Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
  1. Correspondence to Dr Elie A Akl; ea32{at}aub.edu.lb

Abstract

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.

  • funding
  • role of funder
  • randomised controlled trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-015997

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    Footnotes

    • Contributors MBH, GG and EAA conceived and designed the study. MBH coordinated the study throughout. EAA had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. MBH, NJ and MK screened papers for inclusion. MBH, NJ, EAA-J, DJH, EAA-J, LCL, MZH, MA-G and SA extracted the data. MBH and EAA analysed and interpreted the data. MBH wrote the first draft of the manuscript with EAA. MBH and EAA developed the first draft of the fillable PDF document. All authors critically revised the manuscript and approved the final version.

    • Funding This project was funded by the American University of Beirut Faculty of Medicine’s Medical Practice Plan (MPP) funds. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication. The authors and their contributions to the manuscript are independent from the funder.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Data available upon request.