Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study

Abstract

Objective To characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had used to minimise any potential influence, and their experiences and views on conflicts of interest more generally. Design Qualitative interview study. Participants Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expertise. Researchers differed by geographical location, educational background, and experience with different types of funders. Interviewees were identified by searches on Web of Science and snowball sampling. 52 trial researchers were approached by email; 20 agreed to be interviewed. Setting Interviews conducted by telephone, recorded, transcribed verbatim, imported to NVivo 12, and analysed by systematic text condensation. Semistructured interviews focused on financial and non-financial conflicts of interest. Results The interviewees had participated in a median of 37.5 trials and were mainly male physicians who had experience with commercial and non-commercial trial funders. Two predefined themes (influence of conflicts of interest and management strategies) and two additional themes (definition and reporting of conflicts of interest) emerged. Examples of perceived influence of conflicts of interest were: choice of inferior comparator, manipulation of the randomisation process, prematurely stopping the trials, fabrication of data, blocking access to data, and spin (eg, overly favourable interpretation of the results). Examples of strategies to manage conflicts of interest were: disclosure procedures, exclusion of the funder from design and analysis, independent committees, contracts ensuring complete access to the data, and no restriction by the funder on analysis and reporting. Interviewees used different definitions or thresholds for what they considered to be conflicts of interest, and they described different criteria for when to report them. Some interviewees considered non-commercial financial conflicts of interest (eg, funding of trials by governmental health agencies with a political agenda) to be equally or more important than commercial financial conflicts of interest (eg, funding by drug and device companies), but more challenging to report and manage. Conclusion This study described how trial researchers perceive conflicts of interest unduly influencing clinical trials they had worked on, and the management strategies they used to prevent these influences. The results indicated considerable variability in researchers’ understanding of what conflicts of interest are and when they should be reported.

Conflicted and confused? Health harming industries and research funding in leading UK universities

“…The resulting Dowling review acknowledged that universities need policies on conflicts of interest, but its primary concern was for such policies to “help protect individual researchers who receive funding from industry against personal criticisms based on misconceptions about the role of industry in this research.”12 Universities UK, the umbrella organisation for the sector, developed a concordat to support research integrity, which highlights disclosure of conflicts as part of the “proper conduct” of individual researchers 13. Yet, research exploring how researchers actually manage such conflicts finds huge variation, even down to understanding what constitutes a conflict of interest 14…”

“…13 Yet, research exploring how researchers actually manage such conflicts finds huge variation, even down to understanding what constitutes a conflict of interest. 14 …”

Promoting integrity in scholarly research and its publication: International Endodontic Journal policy on reporting conflicts of interest, funding and acknowledgements within manuscripts submitted for publication

“…This could include using an independent consultant for data collection and an independent statistician for data analysis. Some clinical trials use a patient safety monitoring board to help protect the interests of human subjects from any undue influence of a commercial research sponsor (Østengaard et al, 2020).…”

Beyond simple disclosure: addressing concerns about industry influence on public health

“…However, such simple disclosure is insufficient (given the complexities involved in relations with industry), and many researchers are uncertain as to when conflicts of interest need to be declared. 4 Furthermore, conflicts of interest have focused on individuals and not institutions, as identified in at least one case study of how the opioid epidemic was propagated in the USA. 5 In this editorial, we, as members of the International Network for Epidemiology in Policy (https:// epidemiologyinpolicy.…”

“…In situations of ‘appeasement’ such as partnerships between industry and public health professionals (including researchers), declaration of conflicts of interest have been used, often pre-emptively, as a method to deal with potential concerns. However, such simple disclosure is insufficient (given the complexities involved in relations with industry), and many researchers are uncertain as to when conflicts of interest need to be declared 4. Furthermore, conflicts of interest have focused on individuals and not institutions, as identified in at least one case study of how the opioid epidemic was propagated in the USA 5…”