Phase IV Drug Trials With a Canadian Site: A Comparison of Industry-Funded and Non-Industry-Funded Trials.

Recent regulatory reforms have favored expedited drug marketing and increased reliance on Phase IV clinical trials for safety and efficacy assurance. This study, utilizing ClinicalTrials.gov, assesses the characteristics of Phase IV trials, with at least one site in Canada, examining those funded by industry sponsors and those lacking industry funding. Additionally, it compares the publication status of industry-funded and non-industry-funded trials through a manual review of the medical literature. Between 2000 and 2022, 864 Phase IV trials were completed, with 480 (55.6%) receiving industry funding and 384 (44.4%) funded solely by non-industry sources. Industry-funded clinical trials were larger (mean 204 enrollees versus 70), more likely to be international (57.7% versus 9.6%) and reported results more promptly (1.21 years after completion versus 1.85 years), yet both types shared similar designs, outcomes, and completion times. Publication rates were 81.8% for industry-funded and 65.8% for non-industry-funded trials. The ClinicalTrials. gov registry displayed 48 inaccuracies in publication associations, raising concerns about its accuracy. Our findings underscore the existing institutional limitations in ensuring comprehensive reporting and publication of Phase IV trial results funded by both industry and non-industry sources.

Success of Resident Research Grants in Orthopaedic Trauma From 2000 to 2022: A Retrospective Review.

OBJECTIVES: The objective of this study was to determine the publication rate for orthopaedic trauma resident research projects that receive grant funding and the long-term academic involvement of the grant recipients. DESIGN: Retrospective. SETTING: Publically available records for resident research grant recipients. PATIENT SELECTION CRITERIA: Resident research grants on orthopaedic trauma topics from Orthopaedic Trauma Association (OTA), AO North America (AONA), and Orthopaedic Research and Education Foundation from 2000 to 2022. OUTCOME MEASURES AND COMPARISONS: Subsequent related publications, grant size, time to publication, sustained academic involvement of the residents as measured by academic position, total number of publications, and h-index. RESULTS: Three hundred ninety-seven orthopaedic trauma grants (OTA 117, AONA 225, and OREF 55) were identified. A total of 38% (151) of grants resulted in a publication with no significant difference between agencies (P = 0.94). The average amount awarded was $9,843, with no correlation to publication (P = 0.63). The mean time to publication was 3.57 ± 2.33 years. The time to publication for AONA was significantly longer than for OTA (4.14 vs. 2.83 years, P = 0.004). There was no difference in total publications, h-index, or NIH grants between grant recipients from different agencies. More OTA grant recipients held an academic position compared with AONA grant recipients (63% vs. 43%, P = 0.003). Grant awardees with initial publication success were 1.7 times as likely to have a future academic appointment (P = 0.014) and had 1.9 times the number of publications than those without (P = 0.001). Awardees with an h-index in the top quartile were significantly more likely to have published than those with an h-index in the bottom quartile (P = 0.007). CONCLUSIONS: Fewer than half of orthopaedic trauma-related resident research grants resulted in a publication with comparable rates across agencies. Grant size did not predict publication success. Publication success was a positive predictor of continued academic involvement. Most publications occurred within 5 years, suggesting that these grants may be most helpful in career development if awarded during the first 1-2 years of a 5-year orthopaedic residency program.

NIH funding and journal selection: trends in dermatology publication models across tiers from 2021 to 2023.

This study examines the influence of National Institutes of Health (NIH) funding on the publication choices of dermatologists, particularly in terms of journal tiers and pay-to-publish (P2P) versus free-to-publish (F2P) models. Utilizing k-means clustering for journal ranking based on SCImago Journal Rank, h-index, and Impact Factor, journals were categorized into three tiers and 54,530 dermatology publications from 2021 to 2023 were analyzed. Authors were classified as Top NIH Funded or Non-Top NIH Funded according to Blue Ridge Institute for Medical Research rankings. The study finds significant differences in publication patterns, with Top NIH Funded researchers in Tier I journals demonstrating a balanced use of P2P and F2P models, while they preferred F2P models in Tier II and III journals. Non-Top NIH Funded authors, however, opted for P2P models more frequently across all tiers. These data suggest NIH funding allows researchers greater flexibility to publish in higher-tier journals despite publication fees, while prioritizing F2P models in lower-tier journals. Such a pattern indicates that funding status plays a critical role in strategic publication decisions, potentially impacting research visibility and subsequent funding. The study's dermatology focus limits broader applicability, warranting further research to explore additional factors like geographic location, author gender, and research design.

Funding and conclusions of network meta-analyses on targeted therapies in inflammatory diseases: an overview.

OBJECTIVES: To explore the association between industry funding and network meta-analyses' (NMAs) conclusion, and the use in Clinical Practice Guidelines (CPGs) of NMAs. STUDY DESIGN AND SETTING: This was an overview of NMAs and CPGs. We searched PubMed/MEDLINE, Epistemonikos, and several guideline databases up to February 18th 2023. We included CPGs from the last 5 years and NMAs of randomized controlled trials that evaluated targeted therapies in immune-mediated inflammatory diseases. Data extraction and outcome assessments were done in duplicate by independent authors. RESULTS: We included 216 NMAs and 99 CPGs. 31% (67/216) were industry-funded. The proportion of industry-funded NMAs that cited one treatment as being best was 44% (25/57) compared to 26% (30/116) for nonindustry-funded (OR = 2.24 [1.15-4.39]; aOR = 1.76 [0.81-3.81]). The abstract's conclusion of 39/67 (58%) industry-funded and 69/149 (46%) nonindustry-funded NMAs were considered unsupported by the results (OR = 1.61 [0.90-2.89]; aOR = 1.40 [0.71-2.78]). All industry-funded NMAs that cited one treatment as best cited their own sponsored drug. 59/99 (60%) CPGs included at least one NMA, with 23/59 (39%) of them citing industry-funded NMAs. CONCLUSIONS: We did not find evidence that industry-funded NMAs were more likely to have unsupported conclusions or to cite only one treatment as being best in their conclusions compared to non-industry-funded NMAs. However, almost all industry-funded NMAs favored their own treatments. Even though 40% of the CPGs did not rely on NMA, over a third of those who did used industry-funded NMAs. Limitations include the possible misclassification due to undisclosed funding and potential confounders that have not been accounted for.

Cross-disease spillover from research funding: Evidence from four diseases.

There is widespread appreciation for the role of research in addressing health problems. However, there is limited evidence on the extent to which research can be targeted to specific diseases. Analyses highlighting a concentration of research funding towards certain diseases have prompted growing scrutiny over the allocation of research funding. In this paper, we show that research funding targeted to a disease often results in publications relating to other diseases. Using data from the world's largest biomedical research funders, we estimated the frequency and direction of this cross-disease spillover by examining 337,573 grant-publication pairs for four diseases. We found the majority of our grant-publication pairs were cross-disease spillovers. We also found some variation between "rich" and "poor" diseases, in terms of the frequency and direction of cross-disease spillover. These differences are likely to be related to characteristics of the diseases themselves, as well as features of the research environment. One implication of frequent cross-disease spillover is that although more investment in areas of research such as neglected diseases is necessary, it may not be sufficient to improve the alignment between research funding and health needs.

The Intersection of Cardiovascular Health and Maternal Health: Portfolio Analysis of Federal Grant Funding 2016-2021.

Background: The United States has high and increasing rates of maternal morbidity and mortality, large proportions of which are related to cardiovascular health (CVH). Methods: We searched for National Institutes of Health (NIH) supported research as well as that of two other Agencies in the U.S. Department of Health and Human Services (DHHS) for fiscal years (FY) 2016-2021. Grants included maternal health conditions or exposures across all pregnancy stages, but excluded grants that focused entirely on birth, neonatal, infant/childhood outcomes. Results were manually curated by reviewing the abstract and specific aims. Grants deemed to be relevant were grouped by category. Results: Between FY 2016-2021, overall Maternal Health grants remained unchanged at an average of 1.4% of total DHHS grant funding. Maternal CVH-specific (MCVH) funding amounted to $278,926,105 for 755 grants, $191,344,649 was for 534 Type-1 grants, representing a twofold increase. Non-NIH DHHS agencies most commonly funded general Maternal Health related to CVH; NIH focused funding classified as hypertensive disorders of pregnancy, maternal morbidity and mortality, obesity, and diabetes. Non-NIH DHSS Agencies most commonly funded clinical applied research. In addition to clinical applied grants, NIH funded substantial proportions of grants classified as basic research, clinical trials, and/or translational. National Heart, Lung, and Blood Institute (NHLBI) MCVH grants studied participants in the pre-partum period (78.5%), followed by the post-partum period (50.5%), with relatively few in pre-pregnancy and peri-partum periods (10.8% and 9.7%, respectively); at the NIH level, the peri-partum period had better representation at 20.3%, whereas the pre-pregnancy period remained low at 9.9%. Conclusions: Federal grant funding for maternal health including MCVH increased at the same rate as its funding for overall research, and represented only 1.4% of overall total funding. The pre-pregnancy period was understudied in overall NIH funding and represents a gap area whereby funding agencies could further foster research advances.

Underfunding for Research Training and Career Development: The Impact on Family Medicine Research.

BACKGROUND AND OBJECTIVES: The National Institutes of Health and related federal awards for research training (RT) and research career development (RCD) are designed to prepare applicants for research careers. We compared funding rates for RT and RCD for anesthesiology, dermatology, emergency medicine, family medicine, internal medicine, neurology, obstetrics-gynecology, pathology, pediatrics, and psychiatry. METHODS: We estimated the denominator using the number of residency graduates from different specialties from 2001 to 2010 from the Association of American Medical Colleges data. For the numerator, we used published data on federally funded awards by specialty from 2011 to 2020. We also examined the correlation between RCD funding and overall research funding. RESULTS: Family medicine had the lowest rate per graduating resident for RT (0.01%) and RCD (0.77%) awards among 10 specialties and was lower than the mean/median for the other nine specialties, ranging from 2.15%/1.19% and 9.83%/8.74%. We found a strong correlation between rates of RCD awards and mean federal funding per active physician, which was statistically significant (ρ=0.77, P=.0098). CONCLUSIONS: Comparatively low rates for family medicine awards for RT and RCD plausibly contribute to poor federal funding for family medicine research, underscoring the need to bolster the research career pathway in family medicine.

Factors Associated with Research Productivity and National Institutes of Health Funding in Academic Otology.

OBJECTIVES: Bibliometrics, such as the Hirsch index (h-index) and the more recently developed relative citation ratio (RCR), are utilized to evaluate research productivity. Our study evaluates demographics, research productivity, and National Institutes of Health (NIH) funding in academic otology. METHODS: Academic otologists were identified, and their demographics were collected using institutional faculty profiles (N = 265). Funding data were obtained using the NIH Research Portfolio Online Reporting Tools Expenditures and Reports Database. The h-index was calculated using Scopus and mean (m-RCR) and weighted RCR (w-RCR) were calculated using the NIH iCite tool. RESULTS: H-index (aOR 1.18, 95% CI 1.10-1.27, p < 0.001), but not m-RCR (aOR 1.50, 95% CI 0.97-2.31, p = 0.069) or w-RCR (aOR 1.00, 95% CI 0.99-1.00, p = 0.231), was associated with receiving NIH funding. Men had greater h-index (16 vs. 9, p < 0.001) and w-RCR (51.8 vs. 23.0, p < 0.001), but not m-RCR (1.3 vs. 1.3, p = 0.269) than women. Higher academic rank was associated with greater h-index and w-RCR (p < 0.001). Among assistant professors, men had greater h-index than women (9.0 vs. 8.0, p = 0.025). At career duration 11-20 years, men had greater h-index (14.0 vs. 8.0, p = 0.009) and w-RCR (52.7 vs. 25.8, p = 0.022) than women. CONCLUSION: The h-index has a strong relationship with NIH funding in academic otology. Similar h-index, m-RCR, and w-RCR between men and women across most academic ranks and career durations suggests production of similarly impactful research. The m-RCR may correct some deficiencies of time-dependent bibliometrics and its consideration in academic promotion and research funding allocation may promote representation of women in otology. LEVEL OF EVIDENCE: N/A Laryngoscope, 134:3786-3794, 2024.

Placing the US Federal Investment in Religion, Spirituality, and Health Research in Context: A Systematic Review and Comparison with Social Support and Optimism Funding Levels.

Religion and spirituality (R/S) have been linked to better physical and mental health. The US government has funded several research studies that include a focus on R/S but the amount of support over the last several years appears to be declining. To better understand these funding trends for R/S and health research, we chose relevant comparisons from projects that include a focus on social support and optimism. We identified total amount of funding, change in funding patterns over time, and characteristics of funded projects from a large database of US research projects (Federal RePORTER). We reviewed 5093 projects for social support and 6030 projects for optimism before narrowing the number of eligible studies to 170 and 13, respectively. Social support projects received the largest investment of $205 million dollars. Funded awards for social support and optimism remained stable over time while R/S decreased (p = 0.01), intervention research was more characteristic and studies of African-American/Black participants were less characteristic of funded projects in social support than of R/S (ps < 0.001). Future research for R/S and health would likely benefit from continued focus on minority communities and on identifying and developing appropriate interventions to support individual and community health and well-being.

Large Pediatric Randomized Clinical Trials in ClinicalTrials.gov.

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.

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

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

Research Funding, Income, and Career Satisfaction Among Clinician-Scientists in Ophthalmology in the United States.

PURPOSE: The purpose of this study was to characterize clinician-scientists in ophthalmology and identify factors associated with successful research funding, income, and career satisfaction. DESIGN: Cross-sectional study. METHODS: A survey was conducted of clinician-scientists in ophthalmology at US academic institutions between April 17, 2019, and May 19, 2019. Collected information including 1) demographic data; 2) amount, type, and source of startup funding; first extramural grant; and first R01-equivalent independent grant; 3) starting and current salaries; and 4) Likert-scale measurements of career satisfaction were analyzed using multivariate regression. RESULTS: Ninety-eight clinician-scientists in ophthalmology were surveyed across different ages (mean: 48 ± 11 years), research categories, institutional types, geographic regions, and academic ranks. Median startup funding ranged from $50-99k, and median starting salaries ranged from $150-199k. A majority of investigators (67%) received their first extramural award from the National Eye Institute, mainly through K-award mechanisms (82%). The median time to receiving their first independent grant was 8 years, mainly through an R01 award (70%). Greater institutional startup support (P = .027) and earlier extramural grant success (P = .022) were associated with earlier independent funding. Male investigators (P = .001) and MD degreed participants (P = .008) were associated with higher current salaries but not starting salaries. Overall career satisfaction increased with career duration (P = .011) but not with earlier independent funding (P = .746) or higher income (P = .300). CONCLUSIONS: Success in research funding by clinician-scientists in ophthalmology may be linked to institutional support and earlier acquisition of extramural grants but does not impact academic salaries. Nevertheless, career satisfaction among clinician-scientists improves with time, which is not necessarily influenced by research or financial success.

Contemporary Trends and End-Results of National Institutes of Health Grant Funding to Departments of Urology in the United States: A 10-year Analysis.

PURPOSE: We explored the patterns and distribution of National Institutes of Health grant funding for urological research in the United States. MATERIALS AND METHODS: The National Institutes of Health RePORTER database was queried for all grants awarded to urology departments between 2010 and 2019. Information regarding the value of the grant, funded institution, successful publication of the research, and the category of urological subspecialty were collected. Data on principal investigators were extracted from publicly available information. RESULTS: There were 509 grants awarded to Urology between 2010 and 2019 for a total value of $640,873,867, and a median per-project value of $675,484 (IQR 344,170-1,369,385). Over the study period, total funding decreased by 15.6% and was lower compared to other surgical subspecialties. Most grants were awarded by the National Cancer Institute and National Institute of Diabetes and Digestive and Kidney Diseases (85%) to Western or North Central institutions (52.5%), and had principal investigators specialized in urologic oncology (56.4%), followed by general urologists (21.5%). Female principal investigators led 21.6% of Urology grants and were more likely PhD basic scientists than males (64.4% vs 38.2%, p=0.001). In total, 10,404 publications linked to the 509 grants were produced, of which 28.5% were published in journals with an impact factor ≥10. CONCLUSIONS: Urology is underrepresented in National Institutes of Health grant funding compared to other surgical fields. During the past decade there was a further decrease in the total budget of National Institutes of Health grants to Urology.

The impact of gender on scientific writing: An observational study of grant proposals.

OBJECTIVES: This study aimed to determine whether there are differences in the language used in grant applications submitted to a Southern Brazil Research Support Foundation (FAPERGS) according to the gender, career stage, and the number of publications of applicants. STUDY DESIGN AND SETTING: This observational study also evaluated the relationship between gender, career stage, curriculum, and writing characteristics. Summaries of all research proposals in the biomedical field of FAPERGS during the years of 2013 and 2014 were evaluated according to six language patterns (Positive emotions, Negative emotions, Analytic thinking, Clout, Authenticity, and Emotional tone) defined by the LIWC software. Applicant's gender, career stage, and the number of publications were also collected. RESULTS: Three hundred and forty-four (344) grant proposals met the inclusion criteria and were included in the analysis. No statistical differences were observed in the language pattern used by different gender applicants. In the language used by successful and unsuccessful applicants, we only found a small difference for clout (score 54.5 for not funded and 56.5 for funded grants). However, the principal investigators of successful applications had a significantly higher number of papers published (mean number of papers: 104 versus 58.5). CONCLUSIONS: Gender bias appears to be a more complex problem than just the type of language used; the way society is organized causes several gender biases that may be reflected throughout the women's career.