Reporting of financial and non-financial conflicts of interest by authors of 200 randomized controlled trials: a methodological survey




Poster session 2


Monday 24 October 2016 - 15:30 to 16:00


All authors in correct order:

Hakoum MB1, Jouni N2, Abou-Jaoude EA3, Hasbani DJ4, Abou-Jaoude EA5, Lopes LC6, Khaldieh M2, Hammoud MZ7, Al-Gibbawi M4, Anouti S8, Guyatt G9, Akl EA1
1 Clinical Research Institute, American University of Beirut Medical Center, Lebanon
2 American University of Beirut, Lebanon
3 School of Medicine and Biomedical Sciences, State University of New York at Buffalo, USA
4 Faculty of Medicine, American University of Beirut, Lebanon
5 State University of New York at Buffalo, USA
6 Pharmaceutical Science Master Course, University of Sorocaba, Brazil
7 Faculty of Medicine, University of Balamand, Lebanon
8 Department of Epidemiology and Population Health, American University of Beirut, Lebanon
9 Department of Clinical Epidemiology and Biostatistics, McMaster University, Canada
Presenting author and contact person

Presenting author:

Maram Hakoum

Contact person:

Abstract text
Background: There is evidence that financial conflicts of interest (COI) may influence authors' conclusions in randomized controlled trials (RCTs).

Objectives: The objective of this study was to assess whether, and what, COI authors of RCTs report.

Methods: We conducted a survey using standard systematic review methodology. We searched MEDLINE's 119 Core Clinical Journals for RCTs published in 2015. We defined a COI disclosure as the reporting of whether a COI exists or not, and based our classification of COI on a comprehensive framework of the types of COI that exist in healthcare research, including individual COIs (financial, professional, scholarly, advocatory, personal) and institutional COIs (financial, professional, scholarly, and advocatory). We conducted descriptive and regression analyses.

Results: Of the 200 RCTs identified, 188 (94%) reported authors’ COI disclosures, mostly in the main document and several in online ICMJE (International Committee of Medical Journal Editors) forms. Of these 188 RCTs, 57% had at least one author reporting at least one type of COI in addition to at least one author reporting individual financial COI. In contrast, only 3% of RCTs reported non-financial COIs. Institutional COIs were less commonly reported than individual COIs. Trials that reported a contribution by a medical writer did not report the medical writers’ COI disclosures. Regression analyses showed a positive association between reporting individual financial COI and a higher journal impact factor, a larger number of authors, being an author affiliated with an institution from a high income country, and for trials on a pharmacological intervention.

Conclusions: More than half of published RCTs report that authors have COI, particularly financial types. Authors report individual and financial COI more frequently than institutional and non-financial conflicts.