Received Industry Funding Research Articles

Nature and Magnitude of Industry Payments to Fellowship Program Directors in Orthopaedic Surgery.

Previous research has highlighted conflicts of interest stemming from industry funding and education of orthopaedic surgeons. This study sought to define the nature and magnitude of industry payments to orthopaedic surgery fellowship program directors (FPDs) in the United States. This was a retrospective cohort study of orthopaedic surgery FPDs during 2021. Data were obtained from the Accreditation Council for Graduate Medical Education (ACGME) and Centers for Medicare and Medicaid Services. Profiles of orthopaedic surgery FPDs were obtained for ACGME-accredited and non-ACGME-accredited training programs. Nonresearch industry payments from 2015 to 2021 were extracted and adjusted for inflation. Temporal trends were analyzed through the calculation of compound annual growth rates. Comparisons were made with nonparametric tests. Of 600 orthopaedic surgery FPDs, 596 received industry funding (99%), which totaled $340.6 million over the study period. A trend toward greater total annual industry payments over the study period was observed (compound annual growth rate = 3.3%, P = 0.009). Most industry payments were for royalties or licensing ($246.6 million, 72.4%) and consulting fees ($53.6 million, 15.7%). The median total payment per orthopaedic surgery FPD was $49,971 (interquartile range [IQR], $291,674), with 22% receiving between $100,000 and $500,000 and 17% receiving more than $500,000. The highest annual industry payments existed in shoulder and elbow ($41,489, IQR, $170,613) and spine surgery ($26,103; IQR, $84,968). ACGME accreditation status did not influence the magnitude of industry compensation to orthopaedic surgery FPDs across subspecialties (P > 0.05). Men had higher total median annual industry payments versus women ($7,799 [IQR, $47,712] versus $1,298 [IQR, $6,169], P < 0.001). Industry payments to orthopaedic surgery FPDs are ubiquitous, but the magnitude varies by subspecialty. Most industry funding was found in shoulder and elbow and spine surgery. Standards for orthopaedic fellowship education, such as those upheld by accrediting bodies, should include guidelines on how FPDs handle and disclose financial relationships with industry.

Rates of adverse events of antiretroviral therapy in women living with HIV/AIDS: a systematic review and meta-analysis

ObjectiveThere is limited information regarding the incidence of treatment-related adverse events (AE) following antiretroviral therapy (ART) in women. So, this review aimed to describe the incidence of AE of ART...

Extent, transparency and impact of industry funding for pelvic mesh research: a review of the literature

BackgroundConflicts of interest inherent in industry funding can bias medical research methods, outcomes, reporting and clinical applications. This study explored the extent of funding provided to American physician researchers studying surgical mesh used to treat uterine prolapse or stress urinary incontinence, and whether that funding was declared by researchers or influenced the ethical integrity of resulting publications in peer reviewed journals.MethodsPublications identified via a Pubmed search (2014–2021) of the terms mesh and pelvic organ prolapse or stress urinary incontinence and with at least one US physician author were reviewed. Using the CMS Open Payments database industry funding received by those MDs in the year before, of and after publication was recorded, as were each study’s declarations of funding and 14 quality measures.ResultsFifty-three of the 56 studies reviewed had at least one American MD author who received industry funding in the year of, or one year before or after publication. For 47 articles this funding was not declared. Of 247 physician authors, 60% received > $100 while 13% received $100,000-$1,000,000 of which approximately 60% was undeclared. While 57% of the studies reviewed explicitly concluded that mesh was safe, only 39% of outcomes supported this. Neither the quality indicator of follow-up duration nor overall statements as to mesh safety varied with declaration status.ConclusionsJournal editors’ guidelines re declaring conflicts of interest are not being followed. Financial involvement of industry in mesh research is extensive, often undeclared, and may shape the quality of, and conclusions drawn, resulting in overstated benefit and overuse of pelvic mesh in clinical practice.

Financial Relationships in General Surgery Education: Recent Trends in Industry Payments to General Surgery Residency Leadership

Residency programs and their directors frequently receive funding from industry payers. Both general surgery residency program directors (PDs) and assistant program directors (APDs) receive industry funding for various reasons, including educational advancement. This study investigates recent trends in industry payments to both PDs and APDs to better understand the financial relationships among leaders in residency education. We compared industry payments to general surgery residency PDs and APDs from 2019 to 2021 utilizing the U.S. Centers for Medicare & Medicaid Services (CMS) open payments database. In addition, secondary analyses were performed among PDs to assess differences based on gender, practicing surgical specialty, and geographical region. During the study period (2019-2021), PDs received payments amounting to 2,882,821 USD. PDs were found to receive more funding than APDs, with each receiving average funding of 10,045 vs. 323 USD (p < 0.01), respectively, over the study period. There was a significant decrease in total payments from 2019 to 2020 (1,512,190 vs. 868,811 USD; p < 0.01). Total payments made in 2021 were similar compared to 2020 (905,836 vs. 868,811 USD; p = 0.1). We found that male PDs received significantly more in-industry payments when compared to female PDs (11,702 USD per PD vs. 3971 USD per PD, p < 0.01). This study presents initial data that residency program leadership has robust biomedical industry relationships, and further research is warranted to investigate the impacts of these payments on program resources, educational opportunities for residents, and program outcomes. Male PDs received significantly more industry payments when compared to female PDs. Leaders in the surgical training community must cautiously ensure that these industry relationships are appropriately navigated.

Clinical Trials on Cellular Therapy for Children and Adolescents With Cancer: A 15-Year Trend in the United States.

Cellular therapies are frequently studied in clinical trials for pediatric patients with malignant disease. Characteristics of ongoing and completed cellular therapy clinical trials in the U.S. involving children and adolescents have not previously been reported. We searched ClinicalTrials.gov for clinical trials involving cellular therapies enrolling patients under 18 years of age in the U.S. Trials were initially stratified into child-only (maximum age of eligibility <18 years), child/adolescent and young adult (AYA)(maximum age of eligibility ≤21 years), and child/adult (maximum age of eligibility >21 years). Descriptive characteristics and trends over time were analyzed. We included 202 trials posted 2007-2022. Of the 202 trials, only three trials were child-only; thus, our subsequent analysis focused on comparing child/AYA (≤21 years) and child/adult trials (>21 years). One hundred sixty-nine (84%)enrolled both child and adult populations. The vast majority of trials were early phase (phase 1, 1/2, and 2, 198/202, 98%). Chimeric antigen receptor T cell therapies were most commonly studied (88/202, 44%), while natural-killer cell therapies were most common in child/AYA trials (42% vs. 16%). Most trials were single institution-only (130/202, 64%) and did not receive industry funding (163/202, 81%). Studies with industry funding were more likely to be multicenter (64% vs. 29%) and international (31% vs. 0.6%). Notably, no central nervous system tumor-specific trials had industry funding. There was no difference in therapy type based on funding source. Yearly new trial activations increased over the time period studied (p=0.01). The frequency of cellular therapy trial activations enrolling child/AYA patients with cancer in the U.S. has increased over time. Most studies were phase 1 or 2, single institution-only, and not industry-supported. Future opportunities for cell therapy for pediatric cancer should include multi-institutional approaches.

The distribution of industry payments among pediatric dermatologists from 2015 to 2021.

To understand the landscape of industry payments to pediatric dermatologists to foster transparency and identify potential disparities in funding. Using the Centers for Medicare and Medicaid Services (CMS) Open Payments database, a national cross-sectional study was performed examining payments to pediatric dermatologists from 2015 to 2021. Of the 147 pediatric dermatologists who received industry funding, 35 were male and 112 were female. $9 million in payments was amassed, with 10% of pediatric dermatologists accounting for 94% of total industry payments. Consulting was the most common service, with Pfizer Inc., Amgen Inc., and Regeneron Healthcare Solutions Inc. representing the top three companies. Mean payment was $143,836 for males and $35,943 for females (p < .001). Eight female and seven male pediatric dermatologists received payments in the top 10th percentile, with different average payment in this subgroup (females $447,588 vs. males $698,746, p = .03). 11 states did not have a pediatric dermatologist receiving industry payments, while California (19) and Texas (12) had the most. There are approximately 400 board-certified pediatric dermatologists in the United States and fewer than 40% are receiving monetary compensation from private industry. A fraction of physicians accounted for a majority of total industry payments and industry payments to male pediatric dermatologists were higher despite nearly triple the number of female pediatric dermatologists. With the rise of valuable partnerships between healthcare and industry in modern medicine, the implications of geographic, gender, and financial disparity of industry payments in pediatric dermatology are worthy of further study.

Scoping Review of Published Oncology Meta-analyses in High-Impact Oncology Journals

Many meta-analyses have been conducted on a wide array of topics, and many of these have focused on treatment efficacy of drugs or bias in interventional studies on a specific topic. To examine the factors associated with having a positive study conclusion in meta-analyses in the field of oncology. All meta-analyses published between January 1, 2018, and December 31, 2021, on 5 oncology journal websites were identified and study characteristics, study results, and information on study authors were abstracted. The meta-analysis authors' conclusions were coded as positive, negative, or equivocal, and each article subject matter was coded as one that could affect profits and marketing of a company. Whether an association existed between study characteristics and authors' conclusions was also examined. Database searches resulted in 3947 potential articles, of which 93 meta-analyses were included in this study. Of the 21 studies with author funding from industry, 17 studies (81.0%) reported favorable conclusions. Of the 9 studies that received industry funding, 7 (77.8%) reported favorable conclusions, and of the 63 studies that did not have author or study funding from industry, 30 (47.6%) reported favorable conclusions. Studies that were funded through nonindustry sources and authors who had no relevant conflict of interest had the lowest percentage of positive conclusions and the highest percentage of negative and equivocal conclusions compared with studies with other sources of potential conflict of interest. In this cross-sectional study of meta-analyses published in oncology journals, multiple factors were associated with having a positive study conclusion, which suggests that future research should be performed to elucidate reasons for more favorable conclusions among studies with study or author industry funding.

Industry support for dental implant research: A metatrend study of industry partnership in the development of new technologies

Statement of problemIndustry needs scientific knowledge to develop new products and services, and their financial support to dental implant researchers translates into commercial products. Therefore, identifying the relevant factors for a successful industry partnership is important. PurposeThe purpose of this study was to provide a 20-year bibliometric overview of industry-sponsored studies in implant dentistry to identify possible factors involved in industry partnership motivations. Material and methodsA hand search of 6 of the most established journals in the implant dentistry field was performed for articles published in 1999, 2004, 2009, 2014, and 2019. Information regarding the continent of origin of the corresponding author, interinstitute collaboration, type and topic of research, and the h-index of the corresponding author was recorded for each included article. Bivariate and multivariate logistic regression was used to determine statistical relationship between industry support and exploratory factors (α=.05). ResultsA 6% increase in the chance of industry investment was observed over the years (odds ratio [OD]=1.06; P<.001). Studies from North America (OD=4.87; P<.001) and Europe (OD=3.13; P<.001) were more likely to receive industry funding. Data also revealed a direct relationship between the increasing number of institutions involved in the study and the probability of industry funding (OD=1.21; P<.001). Animal studies (OD=2.26; P<.001) about surgical procedures and prosthodontic topics (OD=1.40; P=.044) stood out for having greater industry support. Researchers with an h-index between 31 and 40 were more likely to receive industry financial support (OD=2.46; P=.001). ConclusionsIndustry support for dental implant research was closely aligned with the continent of origin, interinstitute collaboration, type and topic of research, and the h-index of the corresponding author.

Impact of the Clinical Trials Act 2018 on clinical trial activity in Japan from 2018 to 2020: a retrospective database study using new and conventional Japanese registries

ObjectiveTo clarify the impact of Japan’s Clinical Trials Act (CTA), which was enacted in April 2018, on subsequent clinical trial activity through an analysis of Japanese registry data.DesignRetrospective database study.SettingWe...

A99 PHARMACEUTICAL INDUSTRY FUNDING TO GASTROINTESTINAL PATIENT ADVOCACY ORGANIZATIONS

BackgroundPatient advocacy organizations (PAOs) are not-for-profit organizations that aim to support families and individuals afflicted by illnesses. PAOs play a significant role in guiding health policy, providing education to patients, lobbying, and supporting research. Previous studies have demonstrated that PAOs may receive financial payments from pharmaceutical and medical device manufacturers. This may create a risk of conflict of interest.AimsTo assess the prevalence and transparency of financial donations from industry to gastrointestinal patient advocacy groups based in the United States (US).MethodsWe conducted a cross-sectional study to determine the prevalence of industry donations to PAOs. Data was extracted from the Kaiser Health News (KHN) Database, a database that tracked payments from pharmaceutical companies to PAOs in 2015. After an initial list of 1215 PAOs was obtained from the database, authors extracted the annual revenues, websites and mission statements for each PAO. Authors individually screened each organization’s mission statement and website to determine whether their primary scope of focus included gastroenterology. A final list of 11 PAOs with annual revenues surpassing $500,000 USD was included for descriptive analysis. From this list, the annual reports and websites of each group were reviewed to determine the extent of transparency of PAOs disclosing financial relationships with industry sponsors. The primary outcome of our study was the total amount of funding that each PAO received from pharmaceutical companies. The secondary outcome was the self-reported amount of funding stated on each PAO’s website and annual report.ResultsFrom our analysis of 11 PAOs, 9 (81%) organizations received payments from pharmaceutical companies. The median dollar value of donations received was $31,052 USD (IQR=$25 to $302,550). The total dollar value of donations received was $4,059,433 USD. Across the 9 PAOs that received donations, 5 (56%) organizations disclosed a financial relationship with a pharmaceutical company on their website and 2 (22%) disclosed the value of industry donations within a range. No group specified an exact amount of funding received.ConclusionsOur results demonstrate that a majority of US based gastrointestinal PAOs receive funding from pharmaceutical companies. Furthermore, our results show that many PAOs that receive industry funding do not disclose this amount on their website or annual reports. Given their role in providing patient centered support, it is important for PAOs to disclose financial relationships with industry so as to not produce a conflict of interest.Funding AgenciesNone

Gynecologic oncology clinical trials: study the studies to terminate the terminations

<h3>Objectives:</h3> Clinical trials are paramount to safely advancing the standard of care. Trials that are not completed represent a potential misallocation of resources. The objectives of this study are to assess reasons for clinical trial non-completion, and to identify attributes associated with non-completion for trials in gynecologic oncology. <h3>Methods:</h3> Clinical trials in gynecologic oncology were identified by searching ClinicalTrials.gov for the following cancer types: ovarian, uterine, endometrial, cervical, vaginal, and vulvar. Data collection was performed in February 2020. Data on these trials were downloaded from the website and supplemented with manual codification. We excluded trials that were currently active, duplicative, and/or not enrolling patients with gynecologic malignancies. Unadjusted and adjusted logistic regression models were fit to identify trial attributes associated with trial non-completion. Attributes assessed include cancer type, trial phase, sponsor, funding, geography, size, intervention type, purpose, primary outcomes, and NCI involvement. <h3>Results:</h3> A total of 1882 trials met inclusion criteria. Overall, 1480 (79%) of trials were completed and 402 (21%) were either withdrawn, suspended, or terminated. The most common reasons for non-completion were low accrual (n=124, 31%), no reason given (n=89, 22%) or discretion of study principal investigator (n=52, 13%). Thirty-five trials (9%) were not completed due to lack of efficacy at interim analysis, and 17 (4%) due to safety concerns. In unadjusted analysis, trials that were associated with a higher odds of non-completion were those that (1) enrolled ovarian cancer patients, (2) evaluated drug/biologic interventions, (3) had survival as a primary outcome, (4) were early phase 1/2 or 2, and (5) received industry funding. Cervical cancer, NIH funding, and screening/prevention trials were all associated with lower odds of trial non-completion. After mutual adjustment, phase 1/2 or 2 trials (OR = 1.54; 95% CI=1.13 - 2.11, ref=early phase 1 or 1), industry funded trials (OR = 1.45; 95% CI=1.03 - 2.03), and exclusive domestic enrollment (OR = 1.35; 95% CI=1.02 - 1.77) were all associated with higher odds of non-completion. Trials that enrolled at 2-5 sites (OR = 0.66; 95% CI=0.47 - 0.93), as compared to single site, was the only attribute associated with lower odds of non-completion. <h3>Conclusions:</h3> Over 20% of gynecologic oncology clinical trials are not completed. The most common reason for trial non-completion is inadequate accrual. Trials are rarely terminated for safety or efficacy concerns. In multivariate analysis, trials located exclusively in the United States had 35% higher odds of not being completed compared to international trials, and industry funded trials had 45% higher odds of non-completion when compared to trials without industry funding. Insights into why trials are not completed may inform future clinical trial design and ultimately maximize likelihood of completion.

Clinical trials in COVID-19 management & prevention: A meta-epidemiological study examining methodological quality

ObjectiveTo describe the characteristics of Covid-19 randomized clinical trials (RCTs) and examine the association between trial characteristics and the likelihood of finding a significant effect. Study designWe conducted a systematic review to identify RCTs (up to October 21, 2020) evaluating drugs or blood products to treat or prevent Covid-19. We extracted trial characteristics (number of centers, funding sources, and sample size) and assessed risk of bias (RoB) using the Cochrane RoB 2.0 tool. We performed logistic regressions to evaluate the association between RoB due to randomization, single vs. multicentre, funding source, and sample size, and finding a statistically significant effect. ResultsWe included 91 RCTs (n = 46,802); 40 (44%) were single-center, 23 (25.3%) enrolled <50 patients, 28 (30.8%) received industry funding, and 75 (82.4%) had high or probably high RoB. Thirty-eight trials (41.8%) reported a statistically significant effect. RoB due to randomization and being a single-center trial were associated with increased odds of finding a statistically significant effect. ConclusionsThere is high variability in RoB among Covid-19 trials. Researchers, funders, and knowledge-users should be cognizant of the impact of RoB due to randomization and single-center trial status in designing, evaluating, and interpreting the results of RCTs. RegistrationCRD42020192095

Does industry funding differ between men and women in electrophysiology and devices research?

Abstract 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 &amp; 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 &amp;lt; 0.0001. In contrast, women spent a greater time-per-word on their COI disclosure slides (250ms, IQR 125-375ms) compared with men (200ms, IQR 118-333ms), p &amp;lt; 0.0001. 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.

Gender representation in authorship in later-phase systemic clinical trials in biliary tract cancer (BTC).

348 Background: The proportion of females in medicine is increasing (approx. 50% in medical school/workforce), but disparities in female authorship in oncology research publications exist; female corresponding authorship reportedly ranges from 7.2-39.1% in oncology clinical trials (Ludmir et al 2019). This study aimed to describe and assess factors associated with female first and senior authorship in later phase systemic clinical trials in BTC and to identify any changes over time. Methods: Embase/Medline were used to identify final primary trial publications in BTC (2000-2020) (excluding phase I (PI) (expected to move to later phase), mixed tumour site trials, reviews, editorials and trial-in-progress publications). Gender was determined by inspection of names, google search and author communication. Chi-square tests and log regression were used to assess factors associated with female first and senior authorship, including changes over time (STATA16). Results: Of 501 publications, 163 met inclusion criteria; 80% single-arm PII and 15% and 5% randomised PII and PIII respectively; 73% enrolled ≤50 patients. Tumour primary sites were all BTC: 86%, cholangiocarcinoma: 8%, gallbladder cancer: 6%; 80% involved chemotherapy, 13% targeted therapy and 5% localised/systemic combinations; 65% were in first-line (1L) advanced setting, 17% post 1L, 13% advanced non-specified and 5% neo-adjuvant/adjuvant. Forty-eight percent received industry funding and 65% met primary end-point. Sixty-four percent were published post ABC-02 (Valle et al 2010). Publication impact factor (IF) was ≤5 in 50% and &gt;20 in 12%. Median number of authors in all publications was 11. Geographic location of all first and senior authors were Asia (42%/42%), Europe (29%/29%), USA (24%/22%) and other (4%/6%), respectively. Median individual trial female author representation was 25%; there were no female authors in 12% of trials. Overall, female first and senior author representation was 21% and 11%, respectively. Median position of first female author was second. In publications with IF ≤20 and &gt;20, there were 22% and 16% female first and 13% and 0% female senior authors, respectively. The phase of trial, journal IF, industry funding, or whether met primary end-point did not impact female first or senior author representation (all P&gt;.05). There were more female senior authors associated with “other” geographic locations (40% in 10 trials) (P=.016) vs Asia (7%), Europe (8%) and USA (14%). There were no significant changes in female first or senior author representation over time (‘00-05: 21%/18%, ‘06-10: 27%/5%, ‘11-15: 15%/15%, ‘16-20: 22%/9%, P=.738, and P=.508 respectively). Conclusions: Female first and senior author representation in later phase systemic clinical trial publications in BTC is low and has not changed significantly over time. The underlying reasons for this imbalance need to be better understood and addressed.

The Relationship between Industry Payments on Research Productivity and Career Success of Academic Radiation Oncologists

Radiation oncology is a specialty that treats 60% of all cancer patients but receives only 1.6% of total National Institutes of Health funding for cancer research. Industry support to academic radiation oncologists may represent an opportunity to undertake research and enable them to progress their careers, though it also represents potential financial conflict of interest. The Physician Payments Sunshine Act in 2010 required industry funding of physicians to be reported, now enabling assessment of the effects of industry funding on physician productivity in radiation oncology. The goal of this paper is to investigate whether there is a correlation between industry payments and physician productivity and success, as defined by total publications, h-index, or academic rank, for academic radiation oncologists. This study examined the relationship between industry payments, research productivity, and academic title in academic radiation oncologists. Academic radiation oncologists were identified from institutions with residency programs. Industry payments data was obtained from the Center for Medicare and Medicaid Services Open Payment database, and bibliometric data was obtained from Scopus. Sixty-Six percent of academic radiation oncologists received industry payments. The annual mean general payments to Professors, Associate Professors, Assistant Professors, and Instructors were $3,626, $1,293, $622, and $217 respectively. The annual mean research payments were $15,813, $7,022, $1,616, and $293 respectively. Our analysis revealed a significant direct correlation between industry funding and H-index for associate professors, assistant professors, and clinicians/other, but this relationship was not significant for professors and instructors. While univariate analysis revealed both general and research payments were significantly associated with H-index, this association was insignificant for general payments when controlling for academic rank, region, degrees, research payments, and gender. The multivariate model showed that an increase in $10,000 annually in research payments was associated with a 1.19-times increase in odds to be in the top quartile of publications and a 1.10-times increase in odds to be in the top quartile of h-index. Most academic radiation oncologists receive industry funding. Increased research productivity is significantly associated with increased academic rank and research-specific industry payments, but not general industry payments. No conclusions can be made regarding the causal relationship between industry payments and research productivity.

Which Factors Affect the Completion and Publication of Dental Implant Trials?

Clinical decision making in implant dentistry may be vulnerable to industry influence. The purpose of this study was to identify factors associated with the completion and publication of implant trials. This was a cross-sectional study of dental implant trials registered with ClinicalTrials.gov. The predictor variables were composed of a set of study characteristics including study design (investigational or observational), topic, sample size (≤50 or >50 participants), investigator specialty (periodontics, oral-maxillofacial surgery, prosthodontics, general/implantology, or other), study site (United States or international), and industry funding (yes or no). The outcome variables were time to study completion and time to publication. Reverse Kaplan-Meier analyses were used to determine time-to-event probabilities, and Cox proportional hazards models were used to identify factors associated with study completion and publication. A total of 317 trials were included in the final sample. The median trial duration was 2.3years, and the median time from completion to publication was 1.9years. Compared with periodontist-led trials, oral and maxillofacial surgeon-led trials had greater success with publication (publication rate, 73.0% vs 54.4%; P=.01) but were less likely to be conducted in the United States (US site present, 8.8% vs 46.0%; P<.01). Trials that received industry funding were able to extend their operations by an average period of 1.2years (P<.01).The projected trial completion rate at 5years was 78.0%, and the projected publication rate 5years after completion was 94.0%. Multivariate Cox regression showed that both industry-funded trials (hazard ratio, 0.66; P<.01) and pharmacologic studies (hazard ratio, 1.69; P=.02) were significantly associated with the completion rate. Among completed trials, neither industry sponsorship nor any other factor influenced the publication rate over time. Trials that were industry funded had lower rates of completion but not publication. Future efforts should explore the reasons for research waste and improve US oral and maxillofacial surgeon involvement in clinical trial research.

Reporting of financial conflicts of interest by Canadian clinical practice guideline producers: a descriptive study.

The producers of clinical practice guidelines (CPGs) may not disclose industry funding in their CPGs. We reviewed Canadian national CPGs to examine the existence and disclosure of industry-related organizational funding in the CPGs, financial conflicts of interest of committee members and organizational procedures for managing financial conflicts of interest. For this descriptive study, we searched the asset map of the Strategy for Patient-Oriented Research Evidence Alliance and the CPG Infobase for CPGs published between Jan. 1, 2016, and Nov. 30, 2018. Eligible guidelines had to have a national focus and either a first-line drug recommendation or a screening recommendation leading to drug treatment. One investigator reviewed all CPG titles to exclude those that were clearly ineligible. Two reviewers independently reviewed all remaining guidelines and extracted data. We analyzed the data descriptively. We included 21 CPGs: 3 from government-sponsored organizations, 9 from disease or condition interest groups and 9 from medical professional societies. None of the 3 government-sponsored organizations reported industry funding, and none of their committee members disclosed financial conflicts of interest. Among the 18 disease or condition interest groups and medical professional societies, 14 (93%) of the 15 that disclosed funding sources on websites (3 did not disclose) reported organizational funding from industry, but none disclosed this information in the CPGs; 12 (86%) of the 14 with conflict-of-interest disclosure statements in the CPG (4 did not include disclosures) had at least 1 committee member with a financial conflict (mean proportion of committee members with a conflict 56%); and for all 8 CPGs with identifiable chairs or cochairs (chairs or cochairs not reported for 10) at least 1 of these people had a financial conflict of interest. None of the guidelines described a plan to manage organizational financial conflicts of interest. Canadian CPGs are vulnerable to industry influence through funding of producers of guidelines and through the financial conflicts of interest of committee members. The CPG producers that receive industry funding should disclose organizational financial conflicts in the CPGs, should engage independent oversight committees and should restrict voting on recommendations to guideline panelists who have no financial conflicts.

The Quality of Randomized Controlled Trials in High-impact Rheumatology Journals, 1998-2018.

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. 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. 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). 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.

Industry funding of patient and health consumer organisations: systematic review with meta-analysis

ObjectiveTo investigate pharmaceutical or medical device industry funding of patient groups.DesignSystematic review with meta-analysis.Data sourcesOvid Medline, Embase, Web of Science, Scopus, and Google Scholar from inception to January 2018; reference...

3510 Academic influence in gynecologic oncology is associated with industry funding: an analysis of the Open Payments database

OBJECTIVES/SPECIFIC AIMS: Industry payments to physicians can present a conflict of interest. The Physician Payments Sunshine Act mandates the disclosure of these financial relationships to increase transparency. Recent studies in other surgical specialties have shown that research productivity is associated with greater industry funding. In this study, we characterize the relationship between academic influence and industry funding among academic gynecologic oncologists. METHODS/STUDY POPULATION: Departmental websites were used to identify academic gynecologist oncologists and their demographic information. The Hirsch index (h-index) relates an author’s number of publications to number of times referenced by other publications, a validated measure of an author’s academic influence. This was obtained from the Scopus database. The Center for Medicaid and Medicare Services Open Payments online database was searched for all industry payments in 2017. The NIH Reporter online database was searched for active grants. Goodness of fit testing showed that all variables followed nonparametric distributions. Medians were compared using Mann-Whitney U tests and Kruskal-Wallis analysis of variance with post-hoc Dunn’s test. RESULTS/ANTICIPATED RESULTS: Four hundred and sixty-six academic gynecologic oncologists were included in the analysis. In 2017, 89.7% of this group received industry funding totaling $41.4 million. Median industry funding was $453 [IQR $67-19684] and median h-index was 14 [IQR 8-26]. Only 8.1% of gynecologic oncologists were NIH grant recipients and they received significantly higher industry payments ($357 vs. 11,168, P&lt;0.01). Gender and academic rank were not associated with industry funding. Gynecologic oncologists in the highest decile of industry funding received a median payment of $447,651[N=46, IQR $285,770 – 896,310] totaling $36.5 million. The median h-index for this top-earning decile was 23 [N=46, IQR 16.5-30.3]. When stratified by payment amount, median h index increased but only reached statistical significance in the highest cohort receiving &gt;$100,000 (N = 63, P&lt;0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: The majority of academic gynecologic oncologists receive industry funding although there are large variations in payments. Those receiving the largest payments are more likely to hold NIH grants and have greater academic influence.