Conducting evaluations of evidence that are transparent, timely and can lead to health-protective actions.

BACKGROUND: In February 2021, over one hundred scientists and policy experts participated in a web-based Workshop to discuss the ways that divergent evaluations of evidence and scientific uncertainties are used to delay timely protection of human health and the environment from exposures to hazardous agents. The Workshop arose from a previous workshop organized by the European Environment Agency (EEA) in 2008 and which also drew on case studies from the EEA reports on 'Late Lessons from Early Warnings' (2001, 2013). These reports documented dozens of hazardous agents including many chemicals, for which risk reduction measures were delayed for decades after scientists and others had issued early and later warnings about the harm likely to be caused by those agents. RESULTS: Workshop participants used recent case studies including Perfluorooctanoic acid (PFOA), Extremely Low Frequency - Electrical Magnetic Fields (ELF-EMF fields), glyphosate, and Bisphenol A (BPA) to explore myriad reasons for divergent outcomes of evaluations, which has led to delayed and inadequate protection of the public's health. Strategies to overcome these barriers must, therefore, at a minimum include approaches that 1) Make better use of existing data and information, 2) Ensure timeliness, 3) Increase transparency, consistency and minimize bias in evidence evaluations, and 4) Minimize the influence of financial conflicts of interest. CONCLUSION: The recommendations should enhance the production of "actionable evidence," that is, reliable evaluations of the scientific evidence to support timely actions to protect health and environments from exposures to hazardous agents. The recommendations are applicable to policy and regulatory settings at the local, state, federal and international levels.

Conflicts of Interest Among Authors of Systematic Reviews Regarding the Management of Chronic Non-Cancer Pain with Opioids Analgesics.

OBJECTIVE: We sought to determine whether author conflict of interest (disclosed or undisclosed) or industry sponsorship influenced the favorability of reporting of systematic reviews and meta-analyses investigating the use of opioid analgesics for the management of chronic non-cancer pain. METHODS: Our search included the MEDLINE (Ovid) and Embase (Ovid) databases. Study sponsorship was determined using the funding statement provided in each systematic review. Author COI information was extracted from the COI disclosure statement. This information was cross-referenced with information available on the CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office (USPTO), and previously published COI disclosures. RESULTS: Eight systematic reviews authored by 83 authors were included. Of these authors, 19 (23.0%) were found to have a COI, of which the majority (17/19; 89.5%) had at least one undisclosed COI. Despite nearly one-quarter of authors having a COI, we found no association between the presence of a COI and the favorability of results (P = 0.64) or conclusions (P = 0.07). CONCLUSIONS: COI are common and frequently undisclosed among systematic review authors investigating opioid analgesics for the management of chronic non-cancer pain. Despite a high prevalence of COI, we did not find that these author-industry relationships had a significant influence on the favorability of results and conclusions; however, our findings should be considered a lower bound estimate of the true influence author COI have on outcomes of pain medicine systematic reviews secondary to the low sample size included in the present study.

Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on treatments for cannabis use disorder.

Background: Cannabis is the most commonly used illicit drug worldwide. In addition to potential adverse effects, an estimated 9% consistent cannabis users are likely to become dependent and may develop a cannabis use disorder (CUD). Methods: This cross-sectional study developed a search strategy using Ovid, MEDLINE, and Ovid Embase for systematic reviews and meta-analyses focused on CUD treatment in June 2020. These reviews were evaluated for conflicts of interest (COIs) per previously developed classification scheme. Our primary objectives were to (1) evaluate the presence of disclosed or undisclosed COI of systematic review authors, regarding treatment of CUD; and (2) determine whether overall summary effect estimates, narrative results and conclusions were influenced by the presence of disclosed or undisclosed COIs among systematic review authors. Results: Our systematic search returned 560 articles which 9 systematic reviews were eligible for data extraction. We found 77.8% (7/9) contained at least one author with a COI. From the 51 authors included, 29.4% (15/51) were found to have a COI. Forty-four percent (4/9) were funded, 22.2% (2/9) were not funded, and 33.3% (3/9) had no funding statements. Out of the 7 systematic reviews with one or more authors containing COI, 14.2% (1/7) included results favoring the treatment group and 28.6% (2/7) included conclusions favoring the treatment group. Our results showed no significance between funding source and results (p = 0.429) or conclusions. Additionally, we found no significance between the presence of COIs with the favorability of results (p = 0.56) or conclusions. Conclusion: Multiple studies favored the treatment of cannabis-containing products, even though COIs were found in the majority of the systematic reviews. COIs have the ability to sway results of a study, which can affect clinical decision-making. Stricter guidelines should be enforced among authors displaying COIs in systematic reviews studying CUD treatment.

Sponsorship bias in oncology cost effectiveness analysis.

OBJECTIVES: Cost effectiveness analysis (CEA) has been increasingly used to inform cancer treatment coverage policy making worldwide. The primary objective of this study was to assess the association between industry sponsorship and CEA results in oncology. STUDY DESIGN AND SETTING: All CEAs in oncology used incremental cost per quality-adjusted life year (QALY) as health effect identified from the Tufts CEA Registry since 1976 was analyzed. Descriptive analyses were performed to present and compare the characteristics of CEA funded by industry and non-industry. Robust logistic regression was performed to assess the relationship between the industry sponsorship and cost effective conclusion over a wide range of threshold values. RESULTS: A total of 1537 CEAs in oncology published from 1976 to 2021 were included. There were 387 (25.2%) with the industry sponsorship. CEAs sponsored by the industry were more likely to report ICERs below $50,000/QALY (adjusted odds ratio (OR), 1.91, 95% confidence interval (CI), 1.45-2.51, P < 0.001), $100,000/QALY (2.74, 1.98-3.79, P < 0.001), and $150,000/QALY (3.53, 2.37-5.27, P < 0.001) than studies without industry sponsorship. CONCLUSIONS: Our study suggests that there has been a significant sponsorship bias in CEAs in oncology. This bias could have a profound implication on drug pricing and coverage policy making.

Influence of Industry in Hydrocephalus and Vertebral Augmentation Literature.

OBJECTIVE: To investigate whether financial bias exists in hydrocephalus and vertebral augmentation literature. METHODS: A systematic literature search was performed in PubMed of studies concerning vertebral augmentation and cerebrospinal fluid valves. The relationship between reported conflicts of interest and the nature of the conclusion (positive vs. neutral and negative) was analyzed. RESULTS: Having a conflict of interest was significantly associated with reporting a positive conclusion in studies investigating valves for hydrocephalus (92.3% positive conclusion vs. 36.4%; P = 0.001), but not for cement augmentation studies (80.5% positive conclusion vs. 65.7%; P = 0.087). As studies concerning vertebral augmentation implants had only positive conclusions, no analysis could be performed. CONCLUSIONS: Our findings suggest a positive relationship between reported conflict of interest and positive outcome in neurosurgical literature concerning cerebrospinal fluid valves.

Association between industry sponsorship and author conflicts of interest with outcomes of systematic reviews and meta-analyses of interventions for opioid use disorder.

INTRODUCTION: Author conflicts of interest (COI) and industry sponsorship may lead to biased research results and conclusions. Considering the direct influence that systematic reviews have on patient care, including the management of patients being treated for opioid use disorders (OUD), these studies should be free of industry bias. Thus, we sought to determine whether a relationship exists between COI and the favorability of systematic review outcomes using a sample of systematic reviews regarding OUD interventions. METHODS: We searched MEDLINE and Embase for systematic reviews and meta-analysis related to OUD treatment. The study team performed all data extraction in a masked duplicate fashion. We searched for undisclosed COI for each systematic review author in 3 databases--the CMS Open Payments database, Dollars for Profs, and the United States Patent and Trademark Office (USPTO). The research team quantified results using descriptive statistics. We evaluated associations between review characteristics using Fisher's exact tests, when possible. RESULTS: This article includes seventeen systematic reviews and meta-analyses with 81 authors. We found that 25 authors (30.9%) had some form of COI, and 22 (of 25, 88.0%) authors had an undisclosed COI. However, no significant association existed between COI and favorability of results and conclusions. Notably, two systematic reviews (of 17; 11.76%) were industry-sponsored. Similarly, we found no association between the study sponsor source and the favorability of systematic review results and conclusions. CONCLUSIONS: Our results suggest the favorability of systematic review results and conclusions are not influenced by author COI or industry sponsorship. However, nearly one-fourth of authors had an undisclosed COI, further emphasizing the need for standardization and adherence to COI disclosure policies within addiction medicine literature.

Association between author conflicts of interest and industry-sponsorship with the favorability of outcomes of systematic reviews focusing on treatments of erectile dysfunction.

BACKGROUND: Authors' conflicts of interest and industry sponsorship have been shown to influence study outcomes. OBJECTIVE: We aimed to determine whether author conflicts of interest and industry sponsorship influenced the nature of results and conclusions of systematic reviews focusing on treatment interventions for erectile dysfunction. MATERIALS AND METHODS: We searched PubMed and Embase for systematic reviews and meta-analyses focusing on erectile dysfunction treatments published between September 1, 2016, and June 2, 2020. Authors' conflicts of interest were collected from the systematic reviews' disclosure statements. These disclosures were verified using the information provided by the Open Payments, Dollars for Profs, Google Patents, and US Patent and Trademark Office databases and from previously published disclosure statements. RESULTS: Our study included 24 systematic reviews authored by 138 authors. Nineteen authors (13.8%) were found to have conflicts of interest (disclosed, undisclosed, or both). No authors completely disclosed all conflicts. Nine reviews (37.5%) contained at least one author with conflicts of interest; of which eight reported narrative results favoring the treatment group, and seven reported conclusions favoring the treatment group. Of the 15 (62.5%) reviews without a conflicted author, 11 reported results favoring the treatment group, and 12 reported conclusions favoring the treatment group. DISCUSSION: The results and conclusions of systematic reviews for erectile dysfunction treatments did not appear to be influenced by authors who reported conflicts of interest. However, our search algorithm relied on the US-based Open Payments database and a large percentage of reviews in our study were produced by authors with international affiliations. Our study results underscore the difficulties in conducting such analyses. CONCLUSION: Although we found that undisclosed conflicts of interest (COI) were problematic among systematic reviews of erectile dysfunction treatment, only 14% of authors in our sample possessed them and these COI did not appear to influence the favorability of systematic review outcomes.

The influence of industry sponsorship and conflict of interest on results and conclusions of systematic reviews regarding treatment of knee osteoarthritis.

Objective: To assess the influence of industry sponsorship and authors' conflicts of interest on the favorability of results and conclusions of systematic reviews regarding osteoarthritis of the knee. Design: We searched MEDLINE, Embase, and the Cochrane Database of Systematic Reviews on June 26, 2020 for systematic reviews with or without meta-analyses focusing on treatment of osteoarthritis of the knee. Author COI were collected from the systematic review's COI disclosure statement, the CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office (USPTO), as well as previously published COI disclosure statements. Study sponsorship was determined using information provided in each systematic review's funding statement. Results: Our study included 53 systematic reviews conducted by a total of 279 authors. Thirty-one authors (of 279; 11.1%) had one or more COI. Fourteen systematic reviews (of 53; 26.4%) had one or more conflicted authors. Of these reviews, only two (of 14; 14.3%) reported narrative results favoring the treatment group, whereas five (of 14; 35.7%) reported conclusions favoring the treatment group. Our results showed no statistically significant association between the presence of COI and the favorability of results (P= 0.11) and conclusions (P= 0.73). Because our sample only included one industry-sponsored systematic review, we were unable to adequately assess for a relationship between industry-sponsorship and favorability of results and conclusions. Conclusion: We found no association between the favorability of systematic review results and conclusions with either the presence of author's conflicts of interest or industry-sponsorship.

Conflicts of Interest Among Authors of Systematic Reviews and Meta-analyses Investigating Interventions for Melanoma: Cross-sectional Literature Study.

BACKGROUND: Previous studies have highlighted the potential influence that industry relationships may have on the outcomes of medical research. OBJECTIVE: We aimed to determine the prevalence of author conflicts of interest (COIs) in systematic reviews focusing on melanoma interventions, as well as to determine whether the presence of these COIs were associated with an increased likelihood of reporting favorable results and conclusions. METHODS: This cross-sectional study included systematic reviews with or without meta-analyses focusing on interventions for melanoma. We searched MEDLINE and Embase for eligible systematic reviews published between September 1, 2016, and June 2, 2020. COI disclosures were cross-referenced with information from the CMS (Centers for Medicare & Medicaid Services) Open Payments database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office, and previously published COI disclosure statements. Results were quantified using descriptive statistics, and relationships were evaluated by Fisher exact tests. RESULTS: Of the 23 systematic reviews included in our sample, 12 (52%) had at least one author with a COI. Of these 12 reviews, 7 (58%) reported narrative results favoring the treatment group and 9 (75%) reported conclusions favoring the treatment group. Of the 11 systematic reviews without a conflicted author, 4 (36%) reported results favoring the treatment group and 5 (45%) reported conclusions favoring the treatment group. We found no significant association between the presence of author COIs and the favorability of results (P=.53) or conclusions (P=.15). CONCLUSIONS: Author COIs did not appear to influence the outcomes of systematic reviews regarding melanoma interventions. Clinicians and other readers of dermatology literature should be cognizant of the influence that industry may have on the nature of reported outcomes, including those from systematic reviews and meta-analyses.

Association of industry ties with outcomes of studies examining the effect of wholegrain foods on cardiovascular disease and mortality: systematic review and meta-analysis.

OBJECTIVE: To determine if observational studies examining the association of wholegrain foods with cardiovascular disease (CVD) with food industry sponsorship and/or authors with conflicts of interest (COI) with the food industry are more likely to have results and/or conclusions that are favourable to industry than those with no industry ties, and to determine whether studies with industry ties differ in their risk of bias compared with studies with no industry ties. DESIGN: Systematic review and meta-analysis of observational studies. DATA SOURCES: We searched eight databases from 1997 to 2017 and hand searched the reference lists of included studies. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Cohort and case-control studies that quantitatively examined the association of wholegrains or wholegrain foods with CVD outcomes in healthy adults or children. RESULTS: 21 of the 22 studies had a serious or critical risk of bias. Studies with industry ties more often had favourable results compared with those with no industry ties, but the Confidence Interval (CI) was wide, Risk Ratio (RR)=1.44 (95% CI 0.88 to 2.35). The same association was found for study conclusions. We did not find a difference in effect size (magnitude of RRs) between studies with industry ties, RR=0.77 (95% CI 0.58 to 1.01) and studies with no industry ties, RR=0.85 (95% CI 0.73 to 1.00) (p=0.50) I2 0%. These results were comparable for studies that measured the magnitude using Hazard Ratios (HR); industry ties HR=0.82 (95% CI 0.76 to 0.88) versus no industry ties HR=0.86 (95% CI 0.81 to 0.91) (p=0.34) I2 0%. CONCLUSIONS: We did not establish that the presence of food industry sponsorship or authors with a COI with the food industry was associated with results or conclusions that favour industry sponsors. The association of food industry sponsorship or authors with a COI with the food industry and favourable results or conclusions is uncertain. However, our analysis was hindered by the low level of COI disclosure in the included studies. Our findings support international reforms to improve the disclosure and management of COI in nutrition research. Without such disclosures, it will not be possible to determine if the results of nutrition research are free of food industry influences and potential biases. PROSPERO REGISTRATION NUMBER: CRD42017055841.

Industry sponsorship and research outcome: systematic review with meta-analysis.

PURPOSE: Clinical research is widely sponsored by drug and device companies. We investigated whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. This review is an update of a previous Cochrane review. METHODS: In this update we searched MEDLINE and Embase (2010 to February 2015), Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). We included empirical studies that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. Two assessors included papers, extracted data and assessed risk of bias. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether conclusions agreed with results. RESULTS: We included 27 additional papers in this update (review now includes 75 papers). Industry sponsored studies more often had favorable efficacy results, RR: 1.27 (95% CI 1.17-1.37), no difference in harms results RR: 1.37 (95% CI 0.64-2.93) and more often favorable conclusions RR: 1.34 (95% CI 1.19-1.51) compared with non-industry sponsored studies. Nineteen papers reported on sponsorship and efficacy effect size, but could not be pooled due to differences in reporting of data and heterogeneity of results. Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment, follow-up and selective outcome reporting. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.25 (95% CI 1.05-1.50), compared with non-industry sponsored studies. CONCLUSIONS: Drug and device studies sponsored by manufacturing companies have more favorable efficacy results and conclusions than studies sponsored by other sources.

Conflicts of interest in infection prevention and control research: no smoke without fire. A narrative review.

Conflicts of interest (COIs) do occur in healthcare research, yet their impact on research in the field of infection prevention and control (IPC) is unknown. We conducted a narrative review aiming to identify examples of COIs in IPC research. In addition to well-known instances, we conducted PubMed and Google searches to identify and report case studies of COIs in IPC and antimicrobial resistance (AMR), which were chosen arbitrarily following consensus meetings, to illustrate different types of COIs. We also searched the Retraction Watch database and blog to systematically identify retracted IPC and/or infectious disease-related papers. Our review highlights COIs in academic research linked to ties between industry and physicians, journal editors, peer-reviewed journals' choice for publication, and guideline committees participants and authors. It explores how COIs can affect research and could be managed. We also present several selected case studies that involve (1) the chlorhexidine industry and how it has used marketing trials and key opinion leaders to promote off-label use of its products; (2) the copper industry and how reporting of its trials in IPC have furthered their agenda; (3) the influence of a company developing "closed infusion systems" for catheters and how this affects networks in low- and middle-income countries and guideline development; (4) potential perverse incentives hospitals may have in reporting healthcare-associated infection or AMR rates and how government intervention may restrict AMR research for fear of bad publicity and subsequent negative economic consequences. Finally, the analysis of reasons for the retraction of previously published papers highlights the fact that misconduct in research may have other motivations than financial gain, the most visible form of COIs. COIs occur in the field of research in general, and IPC and AMR are no exceptions. Their effects pervade all aspects of the research and publication processes. We believe that, in addition to improvements in management strategies of COIs, increased public funding should be available to decrease researchers' dependency on industry ties. Further research is needed on COIs and their management.

The influence of industry sponsorship on the reporting of subgroup analyses within phase III randomised controlled trials in gastrointestinal oncology.

PURPOSE: Correct interpretation of subgroup analyses (SGA) is important as it influences selection of therapeutic interventions for patient subsets. The primary aim of our study was to compare reporting of SGA between industry and non-industry sponsored trials. METHODS: We performed a systematic literature review and extracted data from journal articles (JA) and conference abstracts (CA) published over a decade reporting SGA results of phase III randomised controlled gastrointestinal (GI) oncology trials with patient participants of ≥150. RESULTS: In JA, SGA was reported in 100/145 (69%) trials: 41/54 industry sponsored (76%; 95% confidence interval [CI]: 63-86%) and 59/91 non-industry sponsored (65%; 95% CI: 55-74%) trials (p = 0.16). In CA, SGA was reported in 86/204 (42%) trials: 43/83 industry sponsored (52%; 95% CI: 41-62%) and 43/121 non-industry sponsored (36%; 95% CI: 28-44%) trials (p = 0.02). Number of SGA performed per trial was significantly larger for industry compared to non-industry sponsored trials in both JA (median 6 versus 2, p = 0.003) and CA (median 1 versus 0, p = 0.023). Claims of subgroup effect were made in 52% of trials in JA and 50% in CA, with significant test of interaction evident in only 25% of JA and 16% of CA, with no difference between industry and non-industry trials. Industry sponsored trials with a significant primary end-point reported more SGA (p < 0.001 JA; p = 0.046 CA). CONCLUSIONS: Industry sponsored trials reported more SGA. Claimed subgroup effects were often not accompanied by significant interaction test; thus circumspection should be adopted when using SGA to deviate from standard therapeutic decision-making in GI oncology.

Spine device clinical trials: design and sponsorship.

BACKGROUND CONTEXT: Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. PURPOSE: To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. STUDY DESIGN: Analysis of data from a publicly available clinical trials database. METHODS: Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. RESULTS: One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. CONCLUSIONS: Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose.

Differences between information in registries and articles did not influence publication acceptance.

OBJECTIVES: To assess whether journals are more likely to reject manuscripts with differences between information in registries and articles. We compared differences by sponsorship and assessed whether selective reporting favored publication of significant outcomes. STUDY DESIGN AND SETTING: Drug trials submitted to eight journals (January 2010-April 2012) were included. Publication status, primary outcomes, enrollment, and sponsorship were extracted. Primary outcomes and enrollment in registries and registration timing were reviewed. Prospective registration included registration before study start. Consistency between registered and reported information was evaluated. RESULTS: For 226 submitted manuscripts, primary outcomes were specified in both article and registry. Sixty six of 226 (29.2%) had primary outcome differences; 14 of 66 manuscripts with differences (21.2%) and 46 of 160 without differences (28.8%) were accepted. Fifty manuscripts (22.4%) had sample size differences; 10 of 50 with differences (20.0%) and 49 of 173 without differences (28.3%) were accepted. Industry-sponsored trials had less differences and were more often prospectively registered. After adjustment for sponsorship, differences and/or retrospective registration were not associated with decreased chance of acceptance (odds ratio 0.56; 95% confidence interval: 0.27, 1.13). Primary outcome differences favored significant outcomes in 49% of manuscripts. CONCLUSION: Differences between registered and reported information are not decisive for rejection. Editors should assess consistency between registries and articles to address selective reporting.

Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor.

OBJECTIVES: To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results. STUDY DESIGN AND SETTING: From a 50% random sample of the randomized controlled trials (RCTs) published in journals indexed in PubMed during 2011, we selected the trials with ≥ 100 participants, evaluating the efficacy and safety of drugs, biologics, and medical devices through a head-to-head comparison. RESULTS: We analyzed 319 trials. Overall, 238,386 of the 289,718 randomized subjects (82.3%) were included in the 182 trials funded by companies. Of the 182 industry-sponsored trials, only 23 had two industry sponsors and only three involved truly antagonistic comparisons. Industry-sponsored trials were larger, more commonly registered, used more frequently noninferiority/equivalence designs, had higher citation impact, and were more likely to have "favorable" results (superiority or noninferiority/equivalence for the experimental treatment) than nonindustry-sponsored trials. Industry funding [odds ratio (OR) 2.8; 95% confidence interval (CI): 1.6, 4.7] and noninferiority/equivalence designs (OR 3.2; 95% CI: 1.5, 6.6), but not sample size, were strongly associated with "favorable" findings. Fifty-five of the 57 (96.5%) industry-funded noninferiority/equivalence trials got desirable "favorable" results. CONCLUSION: The literature of head-to-head RCTs is dominated by the industry. Industry-sponsored comparative assessments systematically yield favorable results for the sponsors, even more so when noninferiority designs are involved.