Objective 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.Design Cross sectional study of randomized controlled trials (RCTs).Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013.Participants Random sample of RCTs focused on drug efficacy.Main outcome measure Association between financial ties of principal investigators and study outcome.Results 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).Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

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Background Widespread restructuring of health delivery systems is underway in the US to reduce costs and improve the quality of healthcare. Objective To describe studies evaluating the impact of system-level interventions (incentives and delivery structures) on the value of US healthcare, defined as the balance between quality and cost. Research Design We identified articles in PubMed (2003 to July 2014) using keywords identified through an iterative process, with reference and author tracking. We searched tables of contents of relevant journals from August 2014 through 11 August 2015 to update our sample. Subjects We included prospective or retrospective studies of system-level changes, with a control, reporting both quality and either cost or utilization of resources. Measures Data about study design, study quality, and outcomes was extracted by one reviewer and checked by a second. Results Thirty reports of 28 interventions were included. Interventions included patient-centered medical home (PCMH) implementations (n=12), pay-for-performance programs (n=10), and mixed interventions (n=6); no other intervention types were identified. Most reports (n=19) described both cost and utilization outcomes. Quality, cost, and utilization outcomes varied widely; many improvements were small and process outcomes predominated. Improved value (improved quality with stable or lower cost/utilization or stable quality with lower cost/utilization) was seen in 23 reports; 1 showed decreased value, and 6 showed unchanged, unclear or mixed results. Study limitations included variability among specific endpoints reported, inconsistent methodologies, and lack of full adjustment in some observational trials. Lack of standardized MeSH terms was also a challenge in the search. Conclusions On balance the literature suggests that health system reforms can improve value. However, this finding is tempered by the varying outcomes evaluated across studies with little documented improvement in outcome quality measures. Standardized measures of value would facilitate assessment of the impact of interventions across studies and better estimates of the broad impact of system change.