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Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

ABSTRACT: To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding. Cross sectional study of randomized controlled trials (RCTs). Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013. Random sample of RCTs focused on drug efficacy. Association between financial ties of principal investigators and study outcome. A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9). Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

SUBMITTER: Ahn R

PROVIDER: S-EPMC5241252 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

Ahn Rosa R Woodbridge Alexandra A Abraham Ann A Saba Susan S Korenstein Deborah D Madden Erin E Boscardin W John WJ Keyhani Salomeh S

BMJ (Clinical research ed.) 20170117

<h4>Objective</h4> To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.<h4>Design</h4> Cross sectional study of randomized controlled trials (RCTs).<h4>Setting</h4> Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.<h4>Participants</h4> Random sample of RCTs focused on dr ...[more]

PMID: 28096109

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Project description:OBJECTIVES:To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes. DESIGN:Cross-sectional study. SETTING:Human subjects drug trials published in 'core clinical' MEDLINE journals in 2013. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials. RESULTS:Of 192 included trials, 134 (70%) were positive and 58 (30%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68%), of which 78% were positive, versus 53% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78%vs48%, P<0.001) and were more likely to have prospectively registered a clearly defined primary outcome(62%vs35%, P<0.001). CONCLUSIONS:Less than half of the trials in this cohort were prospectively registered with a clear primary outcome that was consistent with the primary outcome reported in the published manuscript. The presence of investigator financial ties was associated with higher quality registration practices, though this association diminished after adjusting for factors that impact registration quality.

Project description:OBJECTIVE:To investigate the nature and extent of financial relationships between leaders of influential professional medical associations in the United States and pharmaceutical and device companies. DESIGN:Cross sectional study. SETTING:Professional associations for the 10 costliest disease areas in the US according to the US Agency for Healthcare Research and Quality. Financial data for association leadership, 2017-19, were obtained from the Open Payments database. POPULATION:328 leaders, such as board members, of 10 professional medical associations: American College of Cardiology, Orthopaedic Trauma Association, American Psychiatric Association, Endocrine Society, American College of Rheumatology, American Society of Clinical Oncology, American Thoracic Society, North American Spine Society, Infectious Diseases Society of America, and American College of Physicians. MAIN OUTCOME MEASURES:Proportion of leaders with financial ties to industry in the year of leadership, the four years before and the year after board membership, and the nature and extent of these financial relationships. RESULTS:235 of 328 leaders (72%) had financial ties to industry. Among 293 leaders who were medical doctors or doctors of osteopathy, 235 (80%) had ties. Total payments for 2017-19 leadership were almost $130m (£103m; €119m), with a median amount for each leader of $31?805 (interquartile range $1157 to $254?272). General payments, including those for consultancy and hospitality, were $24.8m and research payments were $104.6m-predominantly payments to academic institutions with association leaders named as principle investigators. Variation was great among the associations: median amounts varied from $212 for the American Psychiatric Association leaders to $518?000 for the American Society of Clinical Oncology. CONCLUSIONS:Financial relationships between the leaders of influential US professional medical associations and industry are extensive, although with variation among the associations. The quantum of payments raises questions about independence and integrity, adding weight to calls for policy reform.

Project description:OBJECTIVES:To investigate the proportion of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies. DESIGN:Cross-sectional study of a stratified random sample of Australian guidelines and writers. SETTING:Guidelines available from Australia's National Health and Medical Research Council guideline database, 2012-2014, stratified across 10 health priority areas. POPULATION:402 authors of 33 guidelines, including up to four from each area, dependent on availability: arthritis/musculoskeletal (3); asthma (4); cancer (4); cardiovascular (4); diabetes (4); injury (3); kidney/urogenital (4); mental health (4); neurological (1); obesity (1). For guideline writers with no disclosures, or who disclosed no ties, a search of disclosures in the medical literature in the 5 years prior to guideline publication identified potentially relevant ties, undisclosed in guidelines. Guidelines were included if they contained recommendations of medicines, and writers included if developing or writing guidelines. MAIN OUTCOME MEASURES:Proportions of guideline writers with potentially relevant undisclosed financial ties to pharmaceutical companies active in the therapeutic area; proportion of guidelines including at least one writer with a potentially relevant undisclosed tie. RESULTS:344 of 402 writers (86%; 95%?CI 82% to 89%) either had no published disclosures (228) or disclosed they had no ties (116). Of the 344 with no disclosed ties, 83 (24%; 95%?CI 20% to 29%) had potentially relevant undisclosed ties. Of 33 guidelines, 23 (70%; 95%?CI 51% to 84%) included at least one writer with a potentially relevant undisclosed tie. Writers of guidelines developed and funded by governments were less likely to have undisclosed financial ties (8.1%vs30.6%; risk ratio 0.26; 95%?CI 0.13 to 0.53; p<0.001). CONCLUSIONS:Almost one in four guideline writers with no disclosed ties may have potentially relevant undisclosed ties to pharmaceutical companies. These data confirm the need for strategies to ensure greater transparency and more independence in relationships between guidelines and industry.

Dataset Information

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

Publications

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

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