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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.

SUBMITTER: Ostengaard L

PROVIDER: S-EPMC7590918 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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

Østengaard Lasse L Lundh Andreas A Tjørnhøj-Thomsen Tine T Abdi Suhayb S Gelle Mustafe H A MHA Stewart Lesley A LA Boutron Isabelle I Hróbjartsson Asbjørn A

BMJ (Clinical research ed.) 20201027

<h4>Objective</h4>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.<h4>Design</h4>Qualitative interview study.<h4>Participants</h4>Trial researchers who had participated in at least 10 clinical trials with methodological or statistical expe ...[more]

PMID: 33109515

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Project description:ObjectiveThis study aimed to systematically review the effects of declared and undeclared conflicts of interest on randomised controlled trials (RCTs) of patient blood management (PBM) interventions.DesignWe performed a secondary analysis of a recently published meta-analysis of RCTs evaluating five common PBM interventions in patients undergoing major surgery.Data sourcesThe databases searched by the original systematic reviews were searched using subject headings and Medical Subject Headings terms according to search strategies from the final search time-points until 1 June 2019.Eligibility criteriaRCTs on PBM irrespective of blinding, language, date of publication and sample size were included. Abstracts and unpublished trials were excluded. Conflicts of interest were defined as sponsorship, funding or authorship by industry, professional PBM advocacy groups or blood services.Data extraction and synthesisThree independent reviewers extracted the data and assessed the risk of bias. Pooled treatment effect estimates were reported as risk ratios (RRs) or standardised mean difference with 95% CIs. Heterogeneity was quantified using the I2 statistic.ResultsThree hundred and eighty-nine RCTs totalling 53 635 participants were included. Thirty-two trials (8%) were considered free from important sources of bias. There was reporting bias favouring PBM interventions on transfusion across all analyses. In trials with no declared author conflicts of interest, the treatment effect on mortality was RR 1.12 (0.86 to 1.45). In trials where author conflicts of interest were declared, the treatment effect on mortality was RR 0.84 (0.69 to 1.03), with significant reporting bias favouring PBM interventions. Trials with declared conflicts linked to professional PBM advocacy groups (five studies, n=977 patients) reported statistically significant reductions in mortality RR 0.40 (0.17 to 0.92), unlike other groups.ConclusionsLow certainty of the evidence that guides PBM implementation is confounded by evidence of reporting bias, and the effects of declared and undeclared conflicts of interest, favouring PBM on important trial outcomes.

Project description:BackgroundAudit and feedback entails systematic documentation of clinical performance based on explicit criteria or standards which is then fed back to professionals in a structured manner. There are potential significant returns on investment from partnerships between existing clinical audit programmes in coordinated programmes of research to test ways of improving the effect of their feedback to drive greater improvements in health care delivery and population outcomes. We explored barriers to and enablers of embedding audit and feedback trials within clinical audit programmes.MethodsWe purposively recruited participants with varied experience in embedded trials in audit programmes. We conducted qualitative semi-structured interviews, guided by behavioural theory, with researchers, clinical audit programme staff and health care professionals. Recorded interviews were transcribed, and data coded and thematically analysed.ResultsWe interviewed 31 participants (9 feedback researchers, 14 audit staff and 8 healthcare professionals, many having dual roles). We identified barriers and enablers for all 14 theoretical domains but no relationship between domains and participant role. We identified four optimal conditions for sustainable collaboration from the perspectives of stakeholders: resources, that is, recognition that audit programmes need to create capacity to participate in research, and research must be adapted to fit within each programme's constraints; logistics, namely, that partnerships need to address data sharing and audit quality, while securing research funding to ensure operational success; leadership, that is, enthusiastic and engaged audit programme leaders must motivate their team and engage local stakeholders; and relationships, meaning that trust between researchers and audit programmes must be established over time by identifying shared priorities and meeting each partner's needs.ConclusionSuccessfully embedding research within clinical audit programmes is likely to require compromise, logistical expertise, leadership and trusting relationships to overcome perceived risks and fully realise benefits.

Project description:BackgroundPeer review is the most widely used method for evaluating grant applications in clinical research. Criticisms of peer review include lack of equity, suspicion of biases, and conflicts of interest (CoI). CoIs raise questions of fairness, transparency, and trust in grant allocation. Few observational studies have assessed these issues. We report the results of a qualitative study on reviewers' and applicants' perceptions and experiences of CoIs in reviews of French academic grant applications.Methodology and principal findingsWe designed a qualitative study using semi-structured interviews and direct observation. We asked members of assessment panels, external reviewers, and applicants to participate in semi-structured interviews. Two independent researchers conducted in-depth reviews and line-by-line coding of all transcribed interviews, which were also subjected to Tropes® software text analysis, to detect and qualify themes associated with CoIs. Most participants (73/98) spontaneously reported that non-financial CoIs predominated over financial CoIs. Non-financial CoIs mainly involved rivalry among disciplines, cronyism, and geographic and academic biases. However, none of the participants challenged the validity of peer review. Reviewers who felt they might be affected by CoIs said they reacted in a variety of ways: routine refusal to review, routine attempt to conduct an impartial review, or decision on a case-by-case basis. Multiple means of managing non-financial CoIs were suggested, including increased transparency throughout the review process, with public disclosure of non-financial CoIs, and careful selection of independent reviewers, including foreign experts and methodologists.ConclusionsOur study underscores the importance of considering non-financial CoIs when reviewing research grant applications, in addition to financial CoIs. Specific measures are needed to prevent a negative impact of non-financial CoIs on the fairness of resource allocation. Whether and how public disclosure of non-financial CoIs should be accomplished remains debatable.

Project description:From April 2015, NHS England (NHSE) started to devolve responsibility for commissioning primary care services to clinical commissioning groups (CCGs). The aim of this paper is to explore how CCGs are managing potential conflicts of interest associated with groups of GPs commissioning themselves or their practices to provide services.We carried out two telephone surveys using a sample of CCGs. We also used a qualitative case study approach and collected data using interviews and meeting observations in four sites (CCGs).We conducted 57 telephone interviews and 42 face-to-face interviews with general practitioners (GPs) and CCG staff involved in primary care co-commissioning and observed 74 meetings of CCG committees responsible for primary care co-commissioning.Conflicts of interest were seen as an inevitable consequence of CCGs commissioning primary care. Particular problems arose with obtaining unbiased clinical input for new incentive schemes and providing support to GP provider federations. Participants in meetings concerning primary care co-commissioning declared conflicts of interest at the outset of meetings. Different approaches were pursued regarding GPs involvement in subsequent discussions and decisions with inconsistency in the exclusion of GPs from meetings. CCG senior management felt confident that the new governance structures and policies dealt adequately with conflicts of interest, but we found these arrangements face limitations. While the revised NHSE statutory guidance on managing conflicts of interest (2016) was seen as an improvement on the original (2014), there still remained some confusion over various terms and concepts contained therein.Devolving responsibility for primary care co-commissioning to CCGs created a structural conflict of interest. The NHSE statutory guidance should be refined and clarified so that CCGs can properly manage conflicts of interest. Non-clinician members of committees involved in commissioning primary care require training in order to make decisions requiring clinical input in the absence of GPs.

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

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

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