Search

Purpose The aims of the current study were 1) to compare the total number and dollar amount of industry funding and National Institutes of Health (NIH) funding to academic orthopedic sports medicine surgeons and 2) to examine the impact of academic influence on industry funding and NIH funding to academic orthopedic sports medicine surgeons. Methods Academic orthopedic sports medicine surgeons were identified using faculty webpages. Academic influence was approximated by a physician's h-index and number of publications and obtained from the Scopus database. Total industry payments were acquired through the Open Payments Database and NIH funding was determined from the NIH website. Statistical analysis was performed using Mann-Whitney U testing and Spearman correlations with significance set at p Results Physicians who received industry research payments and NIH funding had a significantly higher mean h-index and mean total publications than physicians that did not receive industry research payments and NIH funding. There were no significant differences in h-index (p= 0.374) or number of publications (p=0.126) between surgeons receiving industry non-research funding and those who did not. H-index and number of publications were both weakly correlated with the amount of industry research and non-research funding. Conclusion While academic influence is associated with industry research funding and NIH funding, there is no association between measures of academic influence and total industry and industry non-research payments. Combined with the weak associations between academic influence and the amount of industry payments, academic influence does not appear to be a major determinant of industry funding to academic orthopedic sports medicine surgeons. Clinical relevance While surgeons should be cognizant of potential conflicts with industry, the relationship between academic sports medicine surgeons and industry may be less subject to bias than previously believed.

Is industry-funded scientific research likely to be biased towards finding positive results? Is industry more likely to work on topics with likely positive outcomes? Using publication-level data and focusing on food groups that are typically considered healthy, I evaluate each article’s abstract using crowdsourcing tools. I find little evidence to support selection on topics with positive outcomes, but industry is less likely to work on topics classified as unrelated to health. Conditional on a topic, I find that industry-funded research is 3.2% more positive compared to non-industry funded research with grains that receive heavier funding responsible for most of the effect. Industry-funded research is also more likely to receive a mention in certain industry newsletters. Coupled with firm incentives to use science to further their marketing efforts, such increased trade press coverage might play a role in shaping consumers’ opinions on what is healthy.

Most randomised controlled trials (RCTs) in oncology are now funded by the pharmaceutical industry. We explore the extent to which RCT design, results and interpretation differ between industry-funded and non-industry-funded RCTs.In this cross-sectional analysis, a structured literature search was used to identify all oncology RCTs published globally during 2014-2017. Industry funding was identified based on explicit statements in the publication. Descriptive statistics were used to compare elements of trial methodology and output between industry- and non-industry-funded RCTs.The study sample included 694 RCTs; 71% were funded by industry. Industry-funded trials were more likely to test systemic therapy (97% versus 62%; P0.001), palliative-intent therapy (71% versus 41%; P0.001) and study breast cancer (20% versus 12%; P0.001). Industry-funded trials were larger (median sample size 474 versus 375; P0.001) and more likely to meet their primary end point (49% versus 41%; P0.001). Among positive trials, there were no differences in the magnitude of benefit between industry- and non-industry-funded RCTs. Trials funded by industry were published in journals that had a significantly higher median impact factor (21, interquartile range 7, 28) than non-industry-funded trials (impact factor 12, interquartile range 5, 24; P = 0.005); this persisted when adjusted for whether a trial was positive or negative.The vast majority of oncology RCTs are now funded by industry. Industry-funded trials are larger, more likely to be positive, predominantly test systemic therapies in the palliative setting and are published in higher impact journals than trials without industry support.

In recent time, there has been an increased push toward transparency in industry funding toward physicians. The Physician Payments Sunshine Act called for the creation of the Open Payments Database managed by the Centers for MedicareMedicaid Services. To our knowledge, there have been no studies evaluating the trends in payments among adult reconstruction fellowship-trained orthopedic surgeons. The purpose of this study is to investigate trends in all payments to adult reconstruction-trained orthopedic surgeons from 2014 to 2019. Secondary outcomes included evaluating trends in yearly subpayment categories, regional variations, as well as characterizing the top 5 industry companies.A review of the Centers for MedicareMedicaid Services Open Payments Database was performed to identify all payments to adult reconstruction-trained orthopedic surgeons. A total of 94,265 payments were made to 4911 surgeons accounting for a total of $258,865,231.20 during the study period. Our primary outcome was to assess the trend in median payment per year to individual surgeons. Secondary outcomes included evaluating payment trends with respect to subtype, location as defined by United States Census regions, as well as specifics concerning the top 5 companies.Over the study period, there was a nonsignificant increasing trend in median payment per surgeon (r = 0.49, P = .096). However, there was also a significantly increasing trend in the number of payments per year (r = 0.83, P = .014), as well as the number of surgeons receiving payments (r = 0.88, P = .019). With respect to subcategory payments, there were significantly increasing trends in the median payment per surgeon for education (1054%, r = 0.942, P.001) and entertainment/food and beverage expenses (20.2%, r = 0.49, P = .020), as well as a significantly decreasing trend for median honoraria payments per surgeon (20.2%, r = -0.04, P = .005). No significant regional trends were identified. Of the top 5 companies, one demonstrated a significantly decreasing trend in median payment per surgeon (21.6%, r = -0.109, P.001), whereas the others remained unchanged.In this study, we found a nonsignificant increasing trend in payments to adult reconstruction-trained surgeons as well as an increasing number of surgeons receiving payments. There were increasing trends in median payment per surgeon for education and entertainment expenses, but a decreasing trend for honoraria payments. No significant regional trends were identified. The majority of the top 5 companies had nonsignificant trends in their payments. Further studies are needed to characterize the disclosure of payments and the impact of industry payments on clinical outcomes.IV.

Two-thirds of US adults report hearing news stories about diet and health relationships daily or a few times a week. These stories have often been labeled as conflicting. While public opinion suggests conflicting nutrition messages are widespread, there has been limited empirical research to support this belief. This study examined the prevalence of conflicting information in online New York Times' news articles discussing published nutrition research between 1996-2016. It also examined the contextual differences that existed between conflicting studies. The final sample included 375 news articles discussing 416 diet and health relationships (228 distinct relationships). The most popular dietary items discussed were alcoholic beverages (n = 51), vitamin D (n = 26), and B vitamins (n = 23). Over the 20-year study period, 12.7% of the 228 diet and health relationships had conflicting reports. Just under three-fourths of the conflicting reports involved changes in study design, 79% involved changes in study population, and 31% involved changes in industry funding. Conflicting nutrition messages can have negative cognitive and behavioral consequences for individuals. To help effectively address conflicting nutrition news coverage, a multi-pronged approach involving journalists, researchers, and news audiences is needed.

OBJECTIVE To assess the prevalence, magnitude, and disclosure status of industry funding in editorial boards of surgery journals. SUMMARY OF BACKGROUND DATA Financial conflicts of interest (COI) can bias research. While authors seeking to publish in peer-reviewed surgery journals are required to provide COI disclosures, editorial board members' COI disclosures are generally not disclosed to readers. METHODS We present a cross-sectional analysis of industry funding to editorial board members of high-impact surgery journals. We reviewed top US-based surgery journals by impact factor to determine the presence of financial COI in members of each journal's editorial board. The prevalence and magnitude of COI was determined using 2018 industry reported payments found in the CMS Open Payments database. Journal websites were also reviewed looking for the presence of editorial board disclosure statements. RESULTS A total of 1,002 names of editorial board members from the top 10 high-impact American surgery journals were identified. Of 688 individual physicians based in the USA, 452 (65.7%) were found to have received industry payments in 2018, totaling $21,916,503 with a median funding amount per physician of $1,253 (IQR $156 - $10,769). Funding levels varied by surgical specialty and journal. Editorial board disclosure information was found in only 3.3% of physicians. CONCLUSIONS Industry funding to editorial board members of high impact surgery journals is prevalent and underreported. Mechanisms of disclosure for COI are needed at the editorial board level to provide readers full transparency. This would acknowledge this COI of editorial board members, and thereby attempt to potentially further reduce the risk of bias in editorial decisions.

BACKGROUND Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalise efficacy data. OBJECTIVES We aimed to systematically review race and ethnicity reporting and representation, as well as, treatment outcomes in onychomycosis clinical trials. METHODS A PubMed search for onychomycosis clinical trials was performed in August 2020. Primary clinical trial data were included and post hoc analyses were excluded. Categorical variables were compared using chi-squared and Fisher's exact tests. Statistical significance was set at p

Background Low-level light therapy (LLLT) is a recent addition to the pantheon of light-based therapeutic interventions. The absorption of red/near-infrared light energy, a process termed “photobiomodulation,” enhances mitochondrial ATP production, cell signaling, and growth factor synthesis, and attenuates oxidative stress. Photobiomodulation is now highly commercialized with devices marketed directly to the consumer. In the gray area between the commercial and therapeutic sectors, harnessing the clinical potential in reproducible and scientifically measurable ways remains challenging. Objectives The aim of this article was to summarize the clinical evidence for photobiomodulation and discuss the regulatory framework for this therapy Methods A review of the clinical literature pertaining to the use of LLLT for skin rejuvenation (facial rhytids and dyschromias), acne vulgaris, wound healing, body contouring, and androgenic alopecia was performed. Results A reasonable body of clinical trial evidence exists to support the role of low-energy red/near-infrared light as a safe and effective method of skin rejuvenation, treatment of acne vulgaris and alopecia, and, especially, body contouring. Methodologic flaws, small patient cohorts, and industry funding mean there is ample scope to improve the quality of evidence. It remains unclear if light-emitting diode sources induce physiologic effects of compararable nature and magnitude to those of the laser-based systems used in most of the higher-quality studies. Conclusions LLLT is here to stay. However, its ubiquity and commercial success have outpaced empirical approaches on which solid clinical evidence is established. Thus, the challenge is to prove its therapeutic utility in retrospect. Well-designed, adequately powered, independent clinical trials will help us answer some of the unresolved questions and enable the potential of this therapy to be realized.

AIM: To systematically review the literature to compare the efficacy of air polishing to hand or ultrasonic instrumentation to reduce periodontal inflammation during treatment of residual pockets or supportive periodontal care.METHODS: Electronic searches were performed in five different databases, and two databases were used to capture the "grey literature partially." Clinical trials that compared the use of an air-polishing device to either conventional scaling and root planing (hand and/or ultrasonic instrumentation) or no treatment during periodontal therapy were included without restriction of year and publication status. The Joanna Briggs Institute instrument for clinical trials was used to appraise the studies critically. The results were submitted to qualitative descriptive analysis. The systematic review protocol was registered in PROSPERO (CRD420220156176).RESULTS: Electronic searches found 1100 hits published between 2008 and 2019. Thirteen studies were included in the review, out of which four had a follow-up longer than 180 days. Results indicated no differences between the efficacy of air polishing and hand or ultrasonic instruments to reduce periodontal inflammation.CONCLUSIONS: Our findings suggest that there is no difference in the efficacy of air polishing and hand or ultrasonic instrumentation to control biofilm and reduce periodontal inflammation. However, these findings must be carefully interpreted owing to methodological issues, including a short follow-up, and a potential conflict of interest related to industry funding.CLINICAL RELEVANCE: Air polishing for biofilm control may be used as an alternative to hand and ultrasonic instrumentation to reduce periodontal inflammation during treatment of residual pockets or supportive periodontal care.

A prior systematic review on the efficacy of halofuginone (HFG) treatment to prevent or treat cryptosporidiosis in bovine calves was inconclusive. We undertook an updated synthesis and meta-analyses on key outcomes for the treatment of calves with HFG. Evaluated outcomes were oocyst shedding, diarrhoea, mortality and weight gain. Experiments had to describe results for same age animals in contemporary arms. Most doses were 100–150 mcg kg−1 day−1. Results were subgrouped by study design, experiments with the lowest risk of bias and lack of industry funding. Eighteen articles were found that described 25 experiments. Most evidence came from randomized controlled trials in Europe. Significantly lower incidence of oocyst shedding, diarrhoea burden and mortality was reported when treatment started before calves were 5 days old. Most studies reported on outcomes for animals up to at least 28 days old. Publication bias was possible in all outcomes and seemed especially likely for diarrhoea outcomes. Beneficial results when HFG treatment was initiated in calves older than 5 days were also found. Prophylactic treatment to prevent cryptosporidiosis is effective in preventing multiple negative outcomes and is beneficial to calf health and will result in a reduction of environmental contamination by Cryptosporidium oocysts.

Over the past two decades, significant policy shifts within Canada have urged corporations from all sectors, including the extractives industry, to fund and support sport for development (SFD) programming in Indigenous communities, often through corporate social responsibility strategies. The idea that sport is an appropriate tool of development for Indigenous communities in Canada and that the extractives industry is a suitable partner to implement development programs highlight profound tensions regarding ongoing histories of resource extraction and settler colonialism. To explore these tensions, in this paper, the authors drew on interviews conducted with extractives industry representatives of four companies that fund and implement such SFD programs. From these interviews, three overarching discourses emerged in relation to the extractives industry’s role in promoting development through sport: SFD is a catalyst to positive relationships between industry and community, SFD is a contributor to “social good” in Indigenous communities, and extractives industry funding of SFD is “socially responsible.”

Previous studies have identified significant gender discrepancies in grant funding, leadership positions, and publication impact in surgical subspecialties. We investigated whether these discrepancies were also present in academic vascular surgery.Academic websites from institutions with vascular surgery training programs were queried to identify academic faculty, and leadership positions were noted. H-index, number of citations, and total number of publications were obtained from Scopus and PubMed. Grant funding amounts and awards data were obtained from the National Institutes of Health (NIH) and Society for Vascular Surgery websites. Industry funding amount was obtained from the Centers for Medicare and Medicaid Services website. Nonsurgical physicians and support staff were excluded from this analysis.We identified 177 female faculty (18.6%) and 774 male faculty (81.4%). A total of 41 (23.2%) female surgeons held leadership positions within their institutions compared with 254 (32.9%) male surgeons (P = .009). Female surgeons held the rank of assistant professor 50.3% of the time in contrast to 33.9% of men (P .001). The rank of associate professor was held at similar rates, 25.4% vs 20.7% (P = .187), respectively. Fewer women than men held the full professor rank, 10.7% compared with 26.2% (P .001). Similarly, women held leadership positions less often than men, including division chief (6.8% vs 13.7%; P .012) and vice chair of surgery (0% vs 2.2%; P .047), but held more positions as vice dean of surgery (0.6% vs 0%; P .037) and chief executive officer (0.6% vs 0%; P .037). Scientific contributions based on the number of each surgeon's publications were found to be statistically different between men and women. Women had an average of 42.3 publications compared with 64.8 for men (P .001). Female vascular surgeons were cited an average of 655.2 times, less than half the average citations of their male counterparts with 1387 citations (P .001). The average H-index was 9.5 for female vascular surgeons compared with 13.7 for male vascular surgeons (P .001). Correcting for years since initial board certification, women had a higher H-index per year in practice (1.32 vs 1.02; P = .005). Female vascular surgeons were more likely to have received NIH grants than their male colleagues (9.6% vs 4.0%; P = .017). Although substantial, the average value of NIH grants awarded was not statistically significant between men and women, with men on average receiving $915,590.74 ($199,119.00-$2,910,600.00) and women receiving $707,205.35 ($61,612.00-$4,857,220.00; P = .416). There was no difference in the distribution of Society for Vascular Surgery seed grants to women and men since 2007. Industry payments made publicly available according to the Sunshine Act for the year 2018 were also compared, and female vascular surgeons received an average of $2155.28 compared with their male counterparts, who received almost four times as much at $8452.43 (P .001).Although there is certainly improved representation of women in vascular surgery compared with several decades ago, a discrepancy still persists. Women tend to have more grants than men and receive less in industry payments, but they hold fewer leadership positions, do not publish as frequently, and are cited less than their male counterparts. Further investigation should be aimed at identifying the causes of gender disparity and systemic barriers to gender equity in academic vascular surgery.

In the USA, the federal government is still the chief source of external funding for R&D across all industries and academia. Industry funding for universities continues to remain low. There have been many attempts to increase the interactions between industry and academia and, while there is a great deal of interest in building public–private partnerships, the results have not been promising. In this article, the author analyzes data from a number of government sources and other organizations to provide a full picture of the funding landscape in the USA. Some thought is given to why such interactions have not been successful and how we may be able to realign university activities and policies to embrace partnerships with industry.

OBJECTIVE Current data on fellowship choice and completion by neurosurgical residents are limited, especially in relation to gender, scholarly productivity, and career progression. The objective of this study was to determine gender differences in the selection of fellowship training and subsequent scholarly productivity and career progression. METHODS The authors conducted a quantitative analysis of the fellowship training information of practicing US academic neurosurgeons. Information was extracted from publicly available websites, the Scopus database, and the Centers for Medicare and Medicaid Services Open Payments website. RESULTS Of 1641 total academic neurosurgeons, 1403 (85.5%) were fellowship trained. There were disproportionately more men (89.9%) compared to women (10.1%). A higher proportion of women completed fellowships than men (p = 0.004). Proportionally, significantly more women completed fellowships in pediatrics (p < 0.0001), neurooncology (p = 0.012), and critical care/trauma (p = 0.001), while significantly more men completed a spine fellowship (p = 0.012). Within those who were fellowship trained, the academic rank of professor was significantly more commonly held by men (p = 0.001), but assistant professor was held significantly more often by women (p = 0.017). The fellowships with the largest mean h-indices were functional/stereotactic, pediatrics, and critical care/trauma. Despite more women completing neurooncology and pediatric fellowships, men had significantly greater h-indices in these subspecialties compared to women. Women had more industry funding awards than men in pediatrics (p < 0.0001), while men had more in spine (p = 0.023). CONCLUSIONS Women were found to have higher rates for fellowship completion compared with their male counterparts, yet had lower scholarly productivity in every subspecialty. Fellowship choice remains unequally distributed between genders, and scholarly productivity and career progression varies between fellowship choice.

Diverse funding sources, including the government, nonprofit, and industry sectors support academic research, generally, and gambling research, specifically. This funding allows academic researcher...

There is a wage gap among men and women practicing cardiology. Differences in industry funding can be both a consequence of and a contributor to gender differences in salaries. We sought to determine whether gender differences exist in the distribution, types, and amounts of industry payments among men and women in cardiology.In this cross-sectional analysis, we used the Centers for MedicareMedicaid Services Open Payment program database to obtain 2016 industry payment data for US cardiologists. We also used UK Disclosure data to obtain 2016 industry payments to UK cardiologists. Outcomes included the proportions of male and female cardiologists receiving industry funding and the mean industry payment amounts received by male and female cardiologists. Where possible, we also assessed 2014 and 2015 data in both locations.Of the 22,848 practicing Centers for MedicareMedicaid Services US cardiologists in 2016, 20,037 (88%) were men and 2,811 (12%) were women. Proportionally more men than women received industry payments in 2016 (78.0% vs 68.5%, respectively; P .001). Men received higher overall mean industry payments than women ($6,193.25 vs. $2,501.55, P .001). Results were similar in 2014 and 2015. Among UK cardiologists, more men (24.4%) than women (13.5%) received industry payments in 2016 (P .001). However, although the difference in overall industry payments was numerically larger among men compared to women, this did not achieve statistical significance (£2,348.31 vs £1,501.37, respectively, P = .35).Industry payments to cardiologists are common, and there are gender differences in these payments on both sides of the Atlantic.

Objectives To provide recommendations to facilitate the management of severe thermal burns during the acute phase in adults and children. Design A committee of 20 experts was asked to produce recommendations in six fields of burn management, namely, (1) assessment, admission to specialised burns centres, and telemedicine; (2) haemodynamic management; (3) airway management and smoke inhalation; (4) anaesthesia and analgesia; (5) burn wound treatments; and (6) other treatments. At the start of the recommendation-formulation process, a formal conflict-of-interest policy was developed and enforced throughout the process. The entire process was conducted independently of any industry funding. The experts drew up a list of questions that were formulated according to the PICO model (Population, Intervention, Comparison, and Outcomes). Two bibliography experts per field analysed the literature published from January 2000 onwards using predefined keywords according to PRISMA recommendations. The quality of data from the selected literature was assessed using GRADE® methodology. Due to the current paucity of sufficiently powered studies regarding hard outcomes (i.e. mortality), the recommendations are based on expert opinion. Results The SFAR guidelines panel generated 24 statements regarding the management of acute burn injuries in adults and children. After two scoring rounds and one amendment, strong agreement was reached for all recommendations. Conclusion Substantial agreement was reached among a large cohort of experts regarding numerous strong recommendations to optimise the management of acute burn injuries in adults and children.

Universities are an important actor for innovation. Their contributions to technological and scientific knowledge development have been supported by various types of funding. The current study investigates the impacts of two academic research funding sources—industry and competitive—on academic patents. We measure the effects with two indicators—creation of progenitor inventions and the degree of diffusion. Using a patent database, this paper identifies a progenitor invention if a patent is granted without any backward citations and measures the degree of diffusion with patent citations. Focusing on Japanese university patents, the main finding of this paper is that competitive funding tends to produce progenitor inventions whereas industry funding is not likely to do so. By contrast, inventions produced from competitive funding are not likely to diffuse, whereas those produced from industry funding are likely to diffuse. Based on our findings, we argue that the competitive funding may work better when diffusion mechanism is introduced. An example is to increase academic researchers’ proximity to the industry. Additionally, our findings also imply that when setting new funding or changing academic funding system such as replacing block funding with other types, it is important to understand what kind of outcomes are expected from the funding method.

Study objective We aim to investigate spin in emergency medicine abstracts, using a sample of randomized controlled trials from high-impact-factor journals with statistically nonsignificant primary endpoints. Methods This study investigated spin in abstracts of emergency medicine randomized controlled trials from emergency medicine literature, with studies from 2013 to 2017 from the top 5 emergency medicine journals and general medical journals. Investigators screened records for inclusion and extracted data for spin. We considered evidence of spin if trial authors focused on statistically significant results, interpreted statistically nonsignificant results as equivalent or noninferior, used favorable rhetoric in the interpretation of nonsignificant results, or claimed benefit of an intervention despite statistically nonsignificant results. Results Of 772 abstracts screened, 114 randomized controlled trials reported statistically nonsignificant primary endpoints. Spin was found in 50 of 114 abstracts (44.3%). Industry-funded trials were more likely to have evidence of spin in the abstract (unadjusted odds ratio 3.4; 95% confidence interval 1.1 to 11.9). In the abstracts' results, evidence of spin was most often due to authors' emphasizing a statistically significant subgroup analysis (n=9). In the abstracts' conclusions, spin was most often due to authors' claiming they accomplished an objective that was not a prespecified endpoint (n=14). Conclusion Spin was prevalent in the selected randomized controlled trial, emergency medicine abstracts. Authors most commonly incorporated spin into their reports by focusing on statistically significant results for secondary outcomes or subgroup analyses when the primary outcome was statistically nonsignificant. Spin was more common in studies that had some component of industry funding.

BACKGROUND: The goal of this study was to analyze the trends in authorship and study characteristics in Spine using two overlapping ten-year time periods: 2004–2014 and 2007–2017. To our knowledge, no other literature reports study characteristics and authorship in the same time period for spine that would allow for the assessment of confounding factors of trends. METHODS: Authorship and study characteristic data was collected from all scientific manuscripts published in Spine during the years of 2004, 2007, 2014, and 2017. Basic statistics and Kruskal-Wallis test were used to analyze the data. RESULTS: We found a significant increase in total number of authors (P

BACKGROUND Large, randomized controlled trials (RCTs) are essential in answering pivotal questions in child health. METHODS We created a bird’s eye view of all large, noncluster, nonvaccine pediatric RCTs with ≥1000 participants registered in ClinicalTrials.gov (last search January 9, 2020). We analyzed the funding sources, countries, outcomes, publication status, and correlation with the pediatric global burden of disease (GBD) for eligible trials. RESULTS We identified 247 large, nonvaccine, noncluster pediatric RCTs. Only 17 mega-trials with ≥5000 participants existed. Industry funding was involved in only 52 (21%) and exclusively funded 47 (19%) trials. Participants were from high-income countries (HICs) in 100 (40%) trials, from lower-middle-income countries (LMICs) in 122 (49%) trials, and from both HICs and LMICs in 19 (8%) trials; 6 trials did not report participants’ country location. Of trials conducted in LMIC, 43% of investigators were from HICs. Of non-LMIC participants trials (HIC or HIC and LMIC), 39% were multicountry trials versus 11% of exclusively LMIC participants trials. Few trials (18%; 44 of 247) targeted mortality as an outcome. 35% (58 of 164) of the trials completed ≥12 months were unpublished at the time of our assessment. The number of trials per disease category correlated well with pediatric GBD overall (ρ = 0.76) and in LMICs (ρ = 0.69), but not in HICs (ρ = 0.29). CONCLUSIONS Incentivization of investigator collaborations across diverse country settings, timely publication of results of large pediatric RCTs, and alignment with the pediatric GBD are of pivotal importance to ultimately improve child health globally.

ObjectivesThe objective of this study was to assess the uptake of the rheumatoid arthritis core outcome set (RA-COS) using data from multiple data providers, and to investigate factors that may influence this uptake. Study Design and SettingAn observational review was carried out on all clinical trials of rheumatoid arthritis that were indexed on the World Health Organisation-International Clinical Trials Registry Platform (WHO-ICTRP). Various measures of COS uptake were calculated from information presented in the trial registries and trial publications. Logistic regression was conducted to investigate factors thought to be associated with planned COS uptake. ResultsA total of 341 trials were eligible for the evaluation of RA-COS uptake. In the decade leading up to 2019, the assessment of uptake based on published results was maintained at just over 80%. Trials that were not commercially funded were much less likely to plan to measure the RA-COS than those with industry funding (60% versus 80%; adjusted OR 0.18, 95% CI 0.11 to 0.32; pConclusion This study has demonstrated that the use of the WHO-ICTRP can identify a large and geographically diverse range of trials to include in the evaluation of COS uptake.

Background There has been limited progress in the development of novel therapeutics for the treatment of sarcomas. A review of phase I and II clinical trials for sarcomas may give insight into factors influencing sarcoma drug development. Methods An exhaustive analysis of phase I and II clinical trials testing drugs for human sarcoma patients between 1 January 2000 and 1 June 2018 was performed using the PubMed search engine, the Thomson Web of Science, and the National Clinical Trials registry. Recorded outcomes included tested drugs, tested histological subtypes, whether the drug was initially developed for sarcoma, reported funding sources, and whether studies led to phase III trials. Results Out of 238 studies meeting inclusion criteria, 87% (207 studies) reported funding sources. Of these, 59.9% (124/207) reported industry funding, 52.7% (109/207) reported government funding, and 27.5% (57/207) reported private funding. Only 5% (12/238) of phase I and II trials resulted in phase III trials, with 11 of 12 studies funded by industry. Approximately 90% (214/238) of studies tested drugs that were not initially tested in sarcoma, and 60.1% (143/238) of studies grouped different sarcoma histological subtypes together in the same study. Conclusion Industry has funded the majority of phase I and II sarcoma clinical trials that have led to phase III trials. There was a high rate of drugs approved for other cancers and then secondarily tested in sarcoma. Most trials tended to group different sarcoma subtypes rather than studying each subtype separately.

Expanded access is a treatment use of investigational drugs, biologicals or medical devices outside of clinical trials. The purpose of our study was to assess self-reported conflicts of interest (COIs) in oncology expanded access studies. One hundred fifty-eight oncology expanded access studies published from 2013 through 2020 were included. The pharmaceutical industry funded either completely or in part 94 studies (59.49%). The authors disclosed mostly financial COIs, while the number of the reported nonfinancial conflicts was relatively small (3528 and 57 COIs, respectively). The number of articles in which at least one author had a financial COI was 118 (74.68%). The most common financial COI types included advisory board membership/consulting (1471 COIs; 41.7%), followed by honoraria (570 COIs; 16.16%) and research funding (441 COIs; 12.5%). Logistic regression was performed to identify predictors of disclosing financial COIs and positive study's conclusions. On univariate analysis, financial COIs were more likely to occur in studies with at least one center located in the United States (odds ratio [OR], 5.62; 95% confidence interval [CI], 1.57-35.98; P = .02). We also found that positive conclusions about the studied treatments were less likely in studies without industry funding (OR, 0.26; CI, 0.08-0.77; P = .01). Most of the research on COIs in oncology performed to date focused on other types of studies, especially clinical trials. To our knowledge, our study is the first to evaluate COIs in oncology expanded access studies.

Funding Acknowledgements Type of funding sources: None. Background A significant gender bias has been identified in cardiology. Industry funding may be important developing electrophysiology (EP) and devices research. Such funding leads to potential conflicts of interest (COI) which must be disclosed on research presentations. There is limited evidence whether the gender bias in cardiology extends to industry funding of research. Purpose To assess whether COI disclosures in EP and devices presentations at the ESC Annual Congress differ between men and women. Methods Recorded presentations from the Arrhythmia & Devices section of ESC Annual Congresses 2016-2020 were assessed. Presentations were excluded if the original presentation contained no slides, it was a panel discussion, it was a non-scientific presentation, or part of the presentation was missing. Presentations with multiple speakers were also excluded. Chi-squared and Mann-Whitney U tests were used to assess differences between groups for dichotomous and continuous data respectively. Results Of 1,153 presentations assessed, 999 were suitable for inclusion. Women made up 22% (n = 221) of presenters. There was no difference in whether COI declaration slides were missing between women (5.9%, n = 13) and men (7.6%, n = 56), p = 0.38. In those with COI disclosure slides (n = 927), women declared significantly lower median number of COIs (0, IQR 0-3) compared with men (2, IQR 0-8), p Conclusions Women made up a minority of presenters in EP/devices talks at the ESC annual congress. Women were less likely to have COIs which may suggest that they are less likely to receive industry funding. Despite this, women spent a greater amount of time-per-word on their COI slides. The lower number of declared COIs in women highlights another potential area of gender bias in cardiology that needs further investigation so that it can be addressed.

The effect of diet on blood cholesterol concentrations has become controversial. We assessed whether industry-funded studies were more likely than non–industry-funded studies to report conclusions that were not supported by their objective findings. PubMed and Cochrane Central Register of Controlled Trials searches through March 8, 2019, yielded 211 relevant articles. The percentage of industry-funded studies increased from 0% in the 1950s to 60% for 2010 tp 2019 ( P < .001). Of 94 non–industry-funded intervention studies for which the effect of egg ingestion on cholesterol concentrations could be determined, net cholesterol increases were reported in 88 (93%) studies (51% statistically significant, 21% not significant, 21% significance not reported). Among 59 industry-funded intervention studies, net cholesterol increases were reported in 51 (86%) studies (34% statistically significant, 39% not significant, and 14% significance not reported). No studies reported significant cholesterol decreases. Nonsignificant net cholesterol decreases were reported by 6 (6%) non–industry-funded and 8 (14%) industry-funded studies. However, 49% of industry-funded intervention studies reported conclusions that were discordant with study results (ie, net cholesterol increases were described as favorable in the articles’ stated conclusions), compared with 13% of non–industry-funded studies. Readers, editors, and the public should remain alert to funding sources in interpreting study findings and conclusions.

Background: Pre-exposure prophylaxis (PrEP) is integral to the US End of AIDS strategy. However, low adherence, high costs, frequent testing and monitoring side effects make delivery of PrEP complicated. Gilead has sponsored PrEP-related research and access as part of its marketing efforts. We review conflict of interests (COI) in the scientific literature for the US PrEP-related articles to understand the impact of Gilead’s corporate sponsorship. Methods: We searched PubMed for US PrEP articles published in 2018 in the top 10 medical journals and top 10 HIV/AIDS journals and abstracted information on author/institutional COI, type of COI, and favorability of results and conclusions. We identified first three and senior authors from the articles and the leading institutions, defined as institution of three or more authors or participating institutions in a trial. We conducted on searches Google, PubMed, ClinicalTrials.gov, OpenPaymentsData.cms.gov, others to identify potential Gilead support to authors and institutions. Findings: Our search identified 93 articles. Of the 289 first three and senior authors in these articles, 34 (11%) declared a Gilead COI and 28 (10%) had undeclared Gilead COI. There were 51 leading institutions, of which, 12 (24%) declared Gilead COI and 22 (45%) had undeclared COI. Overall, 30 (32%) of the 93 articles had declared Gilead COI. Combining declared and undeclared COIs for authors and institutions provided an overall 83 (89%) articles with a potential Gilead COI. Declared Gilead support was significantly associated with favorable conclusions (p

The relationship between industry payments and academic influence, as measured by the Hirsch index (h-index) and number of publications, among adult reconstruction surgeons is not well characterized. The aims of the present study are to determine the relationship between an adult reconstruction surgeons' academic influence and their relevant industry payments and National Institutes of Health (NIH) funding.Adult reconstruction surgeons were identified through the websites for the orthopedic surgery residency programs in the United States during the 2019-2020 academic year. Academic influence was approximated by each physician's h-index and total number of publications. Industry payment data were obtained through the Open Payments Database, and NIH funding was determined through the NIH website. Mann-Whitney U testing and Spearman correlations were performed to examine relevant associations.Surgeons who received industry research payments had a higher mean h-index (16.1 vs 10.2, P.001) and mean number of publications (79.1 vs 35.9, P.001) than physicians who received no industry research payments. Surgeons receiving NIH funding had a higher mean h-index (48.1 vs 10.4, P.001) and mean number of publications (294.5 vs 36.8, P.001) than surgeons who did not receive NIH funding. There was no association between the average h-index (P = .668) and number of publications (P = .387) among adult reconstruction surgeons receiving industry nonresearch funding.h-index and total publications do not seem to be associated with industry nonresearch payments in the field of total joint arthroplasty. Altogether, these data suggest that industry bias may not play a strong role in total joint arthroplasty.

U.S. universities, which are important producers of new knowledge, have experienced a shift in research funding away from federal and towards private industry sources. This paper compares the effects of federal and private university research funding, using data from 22 universities that include individual-level payments for everyone employed on all grants for each university year and that are linked to patent and Census data, including IRS W-2 records. We instrument for an individual’s source of funding with government-wide R&D expenditure shocks within a narrow field of study. We find that a higher share of federal funding causes fewer but more general patents, more high-tech entrepreneurship, a higher likelihood of remaining employed in academia, and a lower likelihood of joining an incumbent firm. Increasing the private share of funding has opposite effects for most outcomes. It appears that private funding leads to greater appropriation of intellectual property by incumbent firms.

In their recent book Merchants of Doubt [New York:Bloomsbury 2010], Naomi Oreskes and Erik Conway describe the "tobacco strategy" , which was used by the tobacco industry to influence policy makers regarding the health risks of tobacco products. The strategy involved two parts, consisting of (1) promoting and sharing independent research supporting the industry's preferred position and (2) funding additional research, but selectively publishing the results. We introduce a model of the Tobacco Strategy, and use it to argue that both prongs of the strategy can be extremely effective—even when policy makers rationally update on all evidence available to them. As we elaborate, this model helps illustrate the conditions under which the Tobacco Strategy is particularly successful. In addition, we show how journalists engaged in "fair" reporting can inadvertently mimic the effects of industry on public belief.

OBJECTIVEAdult glioblastoma (GBM) has proven refractory to decades of innovation. Oncolytic viral therapy represents a novel therapy that uses viral vectors as both a delivery and therapeutic mechanism to target GBM cells. Despite the growing body of basic science data supporting the feasibility of viral therapy to treat GBM, the reporting of clinical trial results is heterogeneous. Correspondingly, the aim of this study was to present a contemporary summary of the progress all clinical trials have made to date.METHODSThe ClinicalTrials.gov database was reviewed in August 2020 for all possible interventional clinical trials involving viral vector–based therapy to treat adult GBM. These were then screened against selection criteria to identify pertinent clinical trials.RESULTSA total of 29 oncolytic viral therapy trials treating adult GBM were identified. The median start and expected completion years were 2014 and 2020, respectively. At the time of this writing, 10 (35%) trials were reported to have completed recruitment, whereas 7 (24%) were actively recruiting. The median target enrollment number was 36 (range 13–108), with the majority of trials being phase I (n = 18, 62%), and involving secondary GBM among other malignant glioma (n = 19, 66%). A total of 10 unique viral vectors were used across all trials, with the most common being adenovirus (n = 16, 55%). Only 2 (7%) phase I trials to date have reported outcomes on the ClinicalTrials.gov portal. Results of 12 additional clinical trials were found in academic publications, with median progression-free and overall survival times of 3 and 15 months, respectively, after the first viral dose at recurrence. The coordination of the large majority of trials originated from the US (n = 21, 72%), and the median number of testing sites per trial was 1 (range 1–15), via industry funding (n = 18 trials, 62%).CONCLUSIONSThere are multiple early-stage oncolytic viral therapy clinical trials for adult GBM currently active. To date, limited results and outcomes are promising but scarce. The authors expect this to change in the near future because many trials are scheduled to have either nearly or actually reached their expected recruitment completion time. How exactly oncolytic viral therapy will fit into the current treatment paradigms for primary and secondary GBM remains to be seen, and will not be known until safety and toxicity profiles are established by these clinical trials.

Importance Conference proceedings are platforms for early communication and dissemination of relevant and timely topics of interest. More than half of abstracts presented at biomedical conferences fail to be published in full, resulting in wasted time and resources. Objective To systematically review reports evaluating the proportion of abstracts presented at eye and vision conferences that are subsequently published in full and investigate factors associated with publication. Data Sources MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, and reference lists of included reports were systematically searched from inception to January 11, 2019. Study Selection Reports that examined the proportion of abstracts presented at eye and vision conferences and subsequently published in peer-reviewed journals 24 or more months later. Data Extraction and Synthesis Two reviewers independently assessed study eligibility, abstracted data, and evaluated the risk of bias. A meta-analysis was conducted to determine the proportion of abstracts published in full and assess factors associated with subsequent full publication. Main Outcomes and Measures Proportion of abstracts presented at eye and vision conferences subsequently published in full. Results There were 19 reports covering 12 261 abstracts presented at 11 unique eye and vision conferences. The overall risk of bias of the reports was low. The weighted proportion of abstracts published in full was 38.0% (95% CI, 31.7%-44.3%) and 54.9% (95% CI, 34.6%-73.7%) among reports restricted to abstracts describing randomized clinical trials. Nine reports (47.4%) investigated the proportion of abstracts subsequently published by ophthalmic subspecialties, ranging from 28.3% (oculoplastics: 95% CI, 17.2%-42.9%) to 42.7% (glaucoma: 95% CI, 34.7%-51.0%). Oral presentation (risk ratio, 1.45; 95% CI, 1.20-1.76) and basic science (risk ratio, 1.25; 95% CI, 1.05-1.47) were significantly associated with higher full publication; factors not significantly associated with full publication included positive results, randomized clinical trial vs other study design, multicenter study, and industry funding. Conclusion and Relevance More than 60% of abstracts presented at eye and vision conferences were not published in full within 2 years of conference presentation. Failure to disseminate research studies in peer-reviewed journals is not desired, especially when involving human participants.

Objective.Well-designed randomized controlled trials (RCT) mitigate bias and confounding, but previous evaluations of rheumatology trials found high rates of methodological flaws. Outside of rheumatoid arthritis, no studies in the modern era have assessed the quality of rheumatology RCT over time or regarding industry funding.Methods.We identified all RCT published in 3 high-impact rheumatology journals from 1998, 2008, and 2018. Quality metrics derived from a modified Jadad scale were analyzed by year of publication and by funding source.Results.Ninety-six publications met inclusion criteria; 82 of these described the primary analysis of an RCT. Over time (1998–2008–2018), trials were less likely to adequately report dropouts and withdrawals (100% vs 82% vs 60%; p < 0.01) or include an active comparator (44% vs 12% vs 13%; p = 0.01). Later trials were more likely to evaluate biologic therapy (11% vs 38% vs 83%; p < 0.01) and report adequate randomization procedures (39% vs 29% vs 60%; p = 0.04). Seventy-nine percent of trials received industry funding. Industry-funded trials were more likely to report double-blinding (86% vs 53%; p < 0.01), patient-reported outcome measures (77% vs 41%; p < 0.01), and intention-to-treat analyses (86% vs 65%; p = 0.04).Conclusion.Industry-funded trials comprise the majority of RCT published in high-impact rheumatology journals and more frequently report metrics associated with RCT quality. RCT assessing active comparators and nonbiologic therapies have become less common in high-impact rheumatology journals.

ObjectiveTo assess whether an association exists between financial links to the indoor tanning industry and conclusions of indoor tanning literature.DesignSystematic review.Data sourcesPubMed, Embase, and Web of Science, up to 15 February 2019.Study selection criteriaArticles discussing indoor tanning and health were eligible for inclusion, with no article type restrictions (original research, systematic reviews, review articles, case reports, editorials, commentaries, and letters were all eligible). Basic science studies, articles describing only indoor tanning prevalence, non-English articles, and articles without full text available were excluded.Results691 articles were included in analysis, including empiric articles (eg, original articles or systematic reviews) (357/691; 51.7%) and non-empiric articles letters (eg, commentaries, letters, or editorials) (334/691; 48.3%). Overall, 7.2% (50/691) of articles had financial links to the indoor tanning industry; 10.7% (74/691) articles favored indoor tanning, 3.9% (27/691) were neutral, and 85.4% (590/691) were critical of indoor tanning. Among the articles without industry funding, 4.4% (27/620) favored indoor tanning, 3.5% (22/620) were neutral, and 92.1% (571/620) were critical of indoor tanning. Among the articles with financial links to the indoor tanning industry, 78% (39/50) favored indoor tanning, 10% (5/50) were neutral, and 12% (6/50) were critical of indoor tanning. Support from the indoor tanning industry was significantly associated with favoring indoor tanning (risk ratio 14.3, 95% confidence interval 10.0 to 20.4).ConclusionsAlthough most articles in the indoor tanning literature are independent of industry funding, articles with financial links to the indoor tanning industry are more likely to favor indoor tanning. Public health practitioners and researchers need to be aware of and account for industry funding when interpreting the evidence related to indoor tanning.Systematic review registrationPROSPERO CRD42019123617.

WOS: 000446993500007 PubMed ID: 30017220 Background: There are numerous studies discussing thromboprophylaxis after total joint arthroplasty (TJA), with varying conclusions. Patient inclusion criteria may be different for each study, which may lead to selection bias and misrepresentation of data. This study aimed to investigate if industry funding impacted patient demographics and overall reported outcomes of studies analyzing venous thromboembolism (VTE) prevention after TJA. Methods: Electronic searches were completed using Ovid, PubMed, and Embase databases. Studies were included if (1) they are published in the English language between 2000 and 2016; (2) they included patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA); and (3) they evaluated prevention and control of postoperative VTE with at least one of the following thromboprophylactic agents: aspirin, enoxaparin, dalteparin, dabigatran, apixaban, rivaroxaban, dabigatran, ximelagatran, fondaparinux, or coumadin. Data were extracted and analyzed via mixed-effect logistic regression. Results: Fifty-seven studies were included; 29 were industry funded, and 28, nonfunded. There were no significant differences between patient's age, body mass index, or revision exclusions between funded and nonfunded studies. Funded studies reported less pulmonary embolisms, fewer events of major bleeding, and significantly less 90-day mortality compared with nonfunded studies. Conclusion: Industry-funded studies reported less pulmonary embolisms, major bleeding, and mortality compared with nonfunded studies. Detailed demographic data were missing from the literature, and we were unable to demonstrate the cause of different reported outcomes between industry-funded and nonfunded studies. Further investigations should be aimed toward understanding how funded studies report less adverse outcomes in analyzing VTE after TJA. (C) 2018 Elsevier Inc. All rights reserved.

Purpose Sources of funding and principal investigator (PI) leadership for clinical trials using radiation therapy (RT) are not well characterized but are important mediators of innovation, particularly because funding for trials from the National Institutes of Health (NIH) has decreased and industry funding has increased. We sought to determine characteristics of trials using RT that are associated with industry funding, NIH funding, and radiation oncologist (RO) PI leadership. Methods and Materials www.ClinicalTrials.gov was queried for all open, interventional trials that administered RT. Logistic regression was used to identify associations between trial characteristics, receipt of funding type (NIH, industry, or other), and PI leadership. Results The authors identified 1469 oncology trials, of which 41% were based in the United States, 56% were based internationally, and 3% were based in the United States and internationally. Of these, 22% were RT monotherapy, 53% were bimodality (40% RT + drug, 13% RT + surgery), and 24% were trimodality. Although ROs led 60% of all trials, industry-sponsored trials were significantly less likely to have RO PIs (35% RO vs 65% non-RO PI; adjusted odds ratio [aOR], 0.45; 95% confidence interval [CI], 0.28-0.73), to fund trials that did not incorporate drug therapy (aOR, 0.19; 95% CI, 0.10-0.35), or to fund phase III trials (aOR, 0.25; 95% CI, 0.11-0.60) because industry-sponsored trials favored smaller phase I trials. NIH-funded trials were not associated with PI type and, although not statistically significant, favored larger phase III trials (unadjusted OR, 2.06; 95% CI, 0.99-4.29). ROs were less likely to lead trials incorporating drug therapy (aOR, 0.30; 95% CI, 0.22-0.41). Conclusions ROs are less likely than other specialties to lead trials that use RT in combination with drug therapy or surgery and more likely to lead trials supported by nonindustry, non-NIH funding. This suggests a need for ROs to lead multimodality trials and to consider opportunities to interact with industry. As NIH resources decrease, alternative funding is needed to support innovation, particularly in in RT-alone trials.

This brief report examines whether there are differences in aspects of different characteristics, including design/methodologies of responsible gambling (RG), between studies funded by industry as compared to other sources. To investigate this, the authors used those studies included in a recent meta-analysis focusing on the empirical basis of RG initiatives (Ladouceur et al. in Addict Res Theory 25:225-235, 2017). We examined eight associations between funding sources, and different design/methodological characteristics of these studies; type of strategy, inclusion of comparison groups, measurement scales and repeated measures, publication source, number of inclusion criteria met, secondary sources of funding, publication year. The results revealed no statistically significant difference between the funding source, and the index study characteristics. These results do not support claims that funding exerts influence on the design or methodologies of RG studies. However, the absence of statistically significant findings should not be used to assert the absence of a funding effect because there are many reasons for failing to find differences, or interpretation of findings. Unexpectedly, a third of the papers included in this study failed to disclose their funding sources. This finding highlights the need for more open and transparent disclosures.

BACKGROUND It has been previously reported that over 20% of surgical trials will be discontinued prematurely raising ethical and financial concerns. Previous studies have been limited in scope owing to the need for manual review of selected trials. To date, there has been no broad analysis comparing surgical and nonsurgical registered clinical trials. MATERIALS AND METHODS ClinicalTrials.gov was queried October 7, 2017 for all US trials from 2005 to 2017. Trials were assigned to surgical or nonsurgical groups by automated sorting. The sorting algorithm was validated by comparison with manual assignments made by blinded investigators. Comparisons were made between trial status, funding sources, and trial design. The reasons for discontinuation were examined and tabulated. RESULTS The database search yielded 82,719 nonsurgical and 5779 surgical trials after automatic assignment. The algorithm for assignments had an overall accuracy of 87.99% and a positive likelihood ratio of 6.09 and negative likelihood ratio of 0.093. Significant differences existed in trial status (nonsurgical versus surgical: completed: 55.51% versus 39.49%, P

Background: In 2020, the COVID-19 pandemic led to an unprecedented volume of almost 3,000 clinical trials registered worldwide. We aimed to describe the COVID-19 clinical trial research agenda in Germany during the first year of the pandemic. Methods: We identified randomized clinical trials assessing interventions to treat or prevent COVID-19 that were registered in 2020 and recruited or planned to recruit participants in Germany. We requested recruitment information from trial investigators as of April 2021. Results: In 2020, 65 trials were completely (n=27) or partially (n=38) conducted in Germany. Most trials investigated interventions to treat COVID-19 (86.2%; 56/65), in hospitalized patients (67.7%; 44/65), with industry funding (53.8%; 35/65). Few trials were completed (21.5%; 14/65). Overall, 187,179 participants were planned to be recruited (20,696 in Germany), with a median number of 106 German participants per trial (IQR 40 to 345). From the planned German participants, 13.4% were recruited (median 15 per trial (IQR 0 to 44). Conclusions: The overall German contribution to the worldwide COVID-19 clinical trial research agenda was modest. Few trials delivered urgently needed evidence. Most trials did not meet recruitment goals. Evaluation and international comparison of the challenges for conducting clinical trials in Germany is needed.

Background Wide-spread concerns have been raised about possible bias in published surgical non-inferiority trials. Therefore, we performed a comprehensive bibliometric analysis to identify the existence of bias, and provided recommendations for future non-inferiority trials. Methods Databases including MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched (last update on 27 April 2020) to include published phase II and phase III non-inferiority surgical trials. We collected general information and parameters associated with trial design. The association between extracted factors and establishment of non-inferiority was then analyzed. Results A total of 347 trials were included in this study. Only 13 (3.7%) trials reported the pre-specified non-inferiority margin in registration, and 99 (28.5%) trials justified margin selection in ultimate trial publications. A significant association was found between industry funding and increased odds of achieving non-inferiority [odds ratio (OR): 1.17, 95% confidence interval (CI): 1.06 to 1.30, P=0.001]. Moreover, trials which had been presented in conferences were less likely to claim non-inferiority (OR: 0.83, 95% CI: 0.69 to 0.99, P=0.035). Conclusions Our study was the first quantitative analysis revealing the presence of biases in findings of existing surgical non-inferiority trials, which could possibly mislead surgeons' clinical decision making. We suggest improving reporting of detailed study design especially funding sources as well as margin justification for future trials. We also encourage conference presentation of ongoing trials prior to the ultimate publication.

Objectives The aim of this study was to identify and quantify the characteristics of studies associated with the likelihood of publication. Study Design and Setting We searched for manuscripts that tracked cohorts of clinical studies (“cohorts”) that from launch to publication. We explored the association of study characteristics with the probability of publication via traditional meta-analyses and meta-regression using random effects models. Results The literature review identified 85 cohorts of studies that met our inclusion criteria. The probability of publication was significantly higher for studies whose characteristics were favorable (odds ratio [OR] = 2.04; 95% confidence interval [CI]: 1.62, 2.57) or statistically significant (OR = 2.07; 95% CI: 1.52, 2.81), had a multicenter design (OR = 1.32; 95% CI: 1.16, 1.45), and were of later regulatory phase (3/4 vs. 1/2, OR = 1.34; 95% CI: 1.14, 1.49). Industry funding was modestly associated with lower (OR = 0.81; 95% CI: 0.67, 0.99) probability of publication. An exploratory analysis of effect modification revealed that the effect of the study characteristic “favorable results” on likelihood for publication was stronger for industry-funded studies. Conclusion The study characteristics of favorable and significant results were associated with greater probability of publication.

Industry is a major source of funding for scientific research. There is also a growing concern for how it corrupts researchers faced with conflicts of interest. As such, the debate has focused on whether researchers have maintained their integrity. In this article we draw on both the history of medicine and formal modeling to argue that given methodological diversity and a merit-based system, industry funding can bias a community without corrupting any particular individual. We close by considering a policy solution (i.e., independent funding) that may seem to promote unbiased inquiry but that actually exacerbates the problem without additional restrictions.