BACKGROUND:In obstetrics and gynecology (OBGYN) research, gender disparities permeate through leadership, funding, promotion, mentorship, publishing, compensation, and publicity. Few studies have investigated OBGYN clinical trial leadership as it relates to investigator gender. Thus, we undertook an investigation of principal investigator (PI) gender and clinical trial success. OBJECTIVE:To characterize United States (US) OBGYN clinical trials by PI gender and analyze the association between PI gender and features of trial success. STUDY DESIGN:This is a cross-sectional study of all US-based obstetric and gynecologic clinical trials registered on ClinicalTrials.gov (2007-2020). We examined associations between PI gender (ie, led by women, men, or both) and four primary outcomes that capture clinical trial success: early discontinuation (ie, absence of early discontinuation is a feature of success), reporting of complete trials to ClinicalTrials.gov, publication in a peer-reviewed journal, and clinical trial participant diversity (reporting of racial and ethnic diversity data and representation of diverse cohorts). Multivariable analyses controlled for subspecialty, multiple PI status, source of funding, primary purpose, phase, number of arms, enrollment, year of trial registration, blinding, oversight by a Data Safety Monitoring Committee, and number of study sites. Sensitivity analysis accounted for individual PI who led multiple clinical trials. Univariable and multivariable logistic regression analysis models were applied. We conducted multiple imputation for missing covariable data. There were no missing exposure or outcome data in the final cohort. RESULTS:We reviewed 12,635 clinical trials focused on OBGYN. Of the 4342 trials with at least one site in the US, PI names were available for 3087 trials (71.1%). The majority of OBGYN trials were women-led (women 1696, 54.9%; men 1272, 41.2%, coled 119, 3.9%). A greater proportion of obstetrics trials (617, 60.0%) were women-led than gynecology trials (1079, 52.4%). Family planning had the greatest proportion of women-led trials (145, 74.7%), whereas reproductive endocrinology and infertility had the lowest (50, 30.9%). A greater proportion of industry-funded trials were led by men (123, 64.7%). In adjusted analysis, women-led trials had lower odds of early discontinuation (men-led reference; women-led adjusted odds ratio [aOR] 0.58, 95% confidence interval [CI] 0.44, 0.77). Women-led trials reported results less frequently (men-led reference; women-led aOR 0.52, CI 0.40-0.62) but no significant difference was seen in publication (men-led reference; women-led aOR 1.02, CI 0.57, 1.81). Women-led trials had greater odds of reporting race and ethnicity participant data (men-led reference; aOR 1.87, CI 1.27-2.47) but there was no difference in cohort diversity by PI gender. CONCLUSION:Women investigators lead approximately half of OBGYN clinical trials in the US. Women-led trials discontinue less frequently, publish at similar rates, and include data on diversity more frequently than men-led trials. Women are as successful as men in conducting clinical trials and, in certain domains, more successful. Our findings place the impetus on the OBGYN professional ecosystem to support women's academic careers.

Journal Article Corrected proof Neuro-oncology clinical trial locations and social vulnerability in the United States Get access Gabriela T Gomez, Gabriela T Gomez Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, Maryland, USA https://orcid.org/0000-0002-1761-0070 Search for other works by this author on: Oxford Academic Google Scholar Brandon E Turner, Brandon E Turner Department of Radiation Oncology, Brigham and Women’s Hospital, Boston, Massachusetts, USA Search for other works by this author on: Oxford Academic Google Scholar Kristin J Redmond, Kristin J Redmond Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland, USA Search for other works by this author on: Oxford Academic Google Scholar Curtiland Deville, Jr, Curtiland Deville, Jr Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland, USA Search for other works by this author on: Oxford Academic Google Scholar Subha Perni Subha Perni Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA Corresponding Author: Subha Perni, MD, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Y2.5316, 1515 Holcombe Blvd, Houston TX, 77030, USA (SPerni@mdanderson.org) https://orcid.org/0000-0003-2851-4903 Search for other works by this author on: Oxford Academic Google Scholar Neuro-Oncology Practice, npad062, https://doi.org/10.1093/nop/npad062 Published: 20 October 2023 Article history Corrected and typeset: 20 October 2023 Published: 20 October 2023

World Health Day underscores the scientific community’s commitment to achieving health equity for all. It is paramount to eliminate bias in research that has traditionally focused on men, neglecting the specific needs of diverse populations. Innovative clinical trial designs are being developed with more inclusive enrollment. Ensuring equitable access to essential antibiotics, coupled with robust infection prevention and control measures, is vital to safeguarding public health. The pursuit of health equity extends beyond the realm of medicine. Investments in local food production and robust social safety nets are critical for mitigating the effects of climate change on access to healthy diets. Additionally, in times of polycrisis, prioritizing the unique needs of children and empowering community-led healthcare initiatives in conflict zones are essential steps. By taking these actions, we can move closer to realizing everyone’s fundamental right to health.

To characterize United States (US) obstetric clinical trials by principal investigator (PI) sex and analyze the association between PI sex and features of trial success. This is a cross-sectional study of all US-based obstetric clinical trials registered on ClinicalTrials.gov (2007-2020). We examined associations between PI sex and three primary outcomes: early discontinuation, results reporting of complete trials to ClinicalTrials.gov, and publication on PubMed.gov, controlling for number of sites, number of PIs, funding source, and year. We conducted exploratory analyses of other trial features. Of 1287 US-based obstetric trials, 1046 (81.2%) listed PI information. Trials included all female (F:627 trials, 59.9%), all male (M:375, 35.9%), or both male and female PIs (B:44, 4.2%). Most trials (946, 90.4%) reported one PI. The distribution of trials by PI sex was largely unchanged over the study period (Figure 1A). A lower proportion of female trials were discontinued early (F:5.7%, M:12.0%, B:9.1%; p=0.002), whereas results reporting and publication frequencies did not differ significantly by PI sex (p >0.05, Figure 1B). In multivariable analysis, female PI trials had lower odds of early discontinuation than male PI trials (adjusted odds ratio 0.43, 95% confidence interval 0.27-0.69), but demonstrated no differences in results reporting or publication (Figure 2). Female and male PI trials were similar in randomization, blinding, and use of an active comparator (Figure 1B). A lower proportion of female PI trials were industry-funded (F:1.0%, M:2.4%, B:4.5%; p=0.05), included oversight by a data monitoring committee (F:35.1%, M:41.6%, B:54.5%; p=0.05), or had multiple sites (F:16.7%, M:22.1.6%, B:36.4%; p=0.002). In recent years, the majority of obstetric trials were led by female PIs, although the proportion of female PIs remained lower than the proportion of female obstetricians. Female-led trials were less likely to discontinue early but were similar with regard to other characteristics of trial success, such as publication.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Inclusive clinical trials are necessary to improve maternal health equity. We aimed to analyze the current state of race and ethnicity reporting and representation in obstetric trials and the association with trial focus for all U.S.-based obstetric trials between 2007 and 2020. In this cross-sectional, multivariable regression analysis, the exposure variable was clinical trial focus (eg, prematurity), and the outcomes were race and ethnicity reporting and representation of diverse cohorts. Obstetric anesthesia trials reported race and ethnicity the least frequently of all trial foci (adjusted odds ratio 0.2, 95% CI 0.08-0.48). Hypertension and obstetric anesthesia trials enrolled the lowest proportion of Black participants, and prematurity trials enrolled the lowest proportion of Latinx and Asian participants. All researchers should strive to improve measurement and reporting of demographic data as well participation of diverse cohorts.

BACKGROUND:Clinical trials form the backbone of evidence-based medicine. ClinicalTrials.gov is the world's largest clinical trial registry, and the state of clinical trials in plastic and reconstructive surgery (PRS) within that database has not been comprehensively studied. To that end, we explored the distribution of therapeutic areas that are under investigation, impact of funding on study design and data reporting, and trends in research patterns of all PRS interventional clinical trials registered with ClinicalTrials.gov.METHODS:Using the ClinicalTrials.gov database, we identified and extracted all clinical trials relevant to PRS that were submitted between 2007 and 2020. Studies were classified based on anatomic locations, therapeutic categories, and specialty topics. Cox proportional hazard was used to calculate adjusted hazard ratios (HRs) for early discontinuation and results reporting.RESULTS:A total of 3224 trials that included 372,095 participants were identified. The PRS trials grew at an annual rate of 7.9%. The therapeutic classes most represented were wound healing (41.3%) and cosmetics (18.1%). Funding for PRS clinical trials is largely provided through academic institutions (72.7%), while industry and US government constituted a minority. Industry-funded studies were more likely to be discontinued early than those funded by academics (HR, 1.89) or government (HR, 1.92) and to be nonblinded and nonrandomized. Academic-funded studies were the least likely to report results data within 3 years of trial completion (odds ratio, 0.87).CONCLUSIONS:A gulf exists in the representation of different PRS specialties among clinical trials. We highlight the role of funding source in trial design and data reporting to identify a potential source of financial waste and to stress the need for continued appropriate oversight.

Importance:Clinical trials guide evidence-based obstetrics and gynecology (OB-GYN) but often enroll nonrepresentative participants. Objective:To characterize race and ethnicity reporting and representation in US OB-GYN clinical trials and their subsequent publications and to analyze the association of subspecialty and funding with diverse representation. Design and Setting:Cross-sectional analysis of all OB-GYN studies registered on ClinicalTrials.gov (2007-2020) and publications from PubMed and Google Scholar (2007-2021). Analyses included logistic regression controlling for year, subspecialty, phase, funding, and site number. Data from 332 417 studies were downloaded. Studies with a noninterventional design, with a registration date before October 1, 2007, without relevance to OB-GYN, with no reported results, and with no US-based study site were excluded. Exposures:OB-GYN subspecialty and funder. Main Outcomes and Measures:Reporting of race and ethnicity data and racial and ethnic representation (the proportion of enrollees of American Indian or Alaskan Native, Asian, Black, Latinx, or White identity and odds of representation above US Census estimates by race and ethnicity). Results:Among trials with ClinicalTrials.gov results (1287 trials with 591 196 participants) and publications (1147 trials with 821 111 participants), 662 (50.9%) and 856 (74.6%) reported race and ethnicity data, respectively. Among publications, gynecology studies were significantly less likely to report race and ethnicity than obstetrics (adjusted odds ratio [aOR], 0.54; 95% CI, 0.38-0.75). Reproductive endocrinology and infertility trials had the lowest odds of reporting race and ethnicity (aOR, 0.14; 95% CI, 0.07-0.27; reference category, obstetrics). Obstetrics and family planning demonstrated the most diverse clinical trial cohorts. Compared with obstetric trials, gynecologic oncology had the lowest odds of Black representation (ClinicalTrials.gov: aOR, 0.04; 95% CI, 0.02-0.09; publications: aOR, 0.06; 95% CI, 0.03-0.11) and Latinx representation (ClinicalTrials.gov: aOR, 0.05; 95% CI, 0.02-0.14; publications: aOR, 0.23; 95% CI, 0.10-0.48), followed by urogynecology and reproductive endocrinology and infertility. Urogynecology (ClinicalTrials.gov: aOR, 0.15; 95% CI, 0.05-0.39; publications: aOR, 0.24; 95% CI, 0.09-0.58) had the lowest odds of Asian representation. Conclusions and Relevance:Race and ethnicity reporting and representation in OB-GYN trials are suboptimal. Obstetrics and family planning trials demonstrate improved representation is achievable. Nonetheless, all subspecialties should strive for more equitably representative research.

Background: Female underrepresentation in oncology clinical trials can result in outcome disparities. We evaluated female participant representation in US oncology trials by intervention type, cancer site, and funding. Materials and Methods: Data were extracted from the publicly available Aggregate Analysis of ClinicalTrials.gov database. Initially, 270,172 studies were identified. Following the exclusion of trials using Medical Subject Heading terms, manual review, those with incomplete status, non-US location, sex-specific organ cancers, or lacking participant sex data, 1650 trials consisting of 240,776 participants remained. The primary outcome was participation to prevalence ratio (PPR): percent females among trial participants divided by percent females in the disease population per US Surveillance, Epidemiology, and End Results Program data. PPRs of 0.8-1.2 reflect proportional female representation. Results: Females represented 46.9% of participants (95% CI, 45.4-48.4); mean PPR for all trials was 0.912. Females were underrepresented in surgical (PPR 0.74) and other invasive (PPR 0.69) oncology trials. Among cancer sites, females were underrepresented in bladder (odds ratio [OR] 0.48, 95% CI 0.26-0.91, P =.02), head/neck (OR 0.44, 95% CI 0.29-0.68, P <.01), stomach (OR 0.40, 95% CI 0.23-0.70, P <.01), and esophageal (OR 0.40 95% CI 0.22-0.74, P <.01) trials. Hematologic (OR 1.78, 95% CI 1.09-1.82, P <.01) and pancreatic (OR 2.18, 95% CI 1.46-3.26, P <.01) trials had higher odds of proportional female representation. Industry-funded trials had greater odds of proportional female representation (OR 1.41, 95% CI 1.09-1.82, P =.01) than US government and academic-funded trials. Conclusions: Stakeholders should look to hematologic, pancreatic, and industry-funded cancer trials as exemplars of female participant representation and consider female representation when interpreting trial results.

OBJECTIVE:To describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. METHODS:Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. RESULTS:2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p < 0.0001). CONCLUSION:Less than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.

Background This study was conducted to determine whether demographic representation among U.S. Department of Veterans Affairs (VA)-sponsored trials differs from trials without VA sponsorship, with reference to VA patient demographics. Methods U.S. clinical trials registered between 1 March 2000 and 1 February 2022 were stratified into VA and non-VA groups. Outcomes included the combined percentage of non-White participants in each trial and enrollment of each demographic subgroup. Trial strata were summarized using medians; Wilcoxon rank sum and one-sample signed rank tests were used to compare demographic representation between (i) VA and non-VA trials and (ii) VA trials and Veterans Health Administration (VHA) patient demographics, respectively. Results We identified 13,826 trials with available data, including 521 VA and 13,305 non-VA-sponsored trials. Median non-White enrollment was 68% greater in VA trials (P < .001) than in non-VA trials, driven by greater enrollment of Black participants (23.5% vs. 10.4%; P < .001). Black participant enrollment in VA trials exceeded representation among VHA beneficiaries (23.5% vs. 15.8%, P < .001). Conclusions This study highlights the increased Black representation in VA-sponsored clinical trials, which is greater than expected after accounting for VHA clinical population demographics. Partnership with the VA may represent a meaningful avenue for increasing Black representation in clinical trials.

Inclusive clinical trials are necessary to improve maternal health equity. We aimed to analyze the current state of race and ethnicity reporting and representation in obstetric trials and the association with trial focus for all U.S.-based obstetric trials between 2007 and 2020. In this cross-sectional, multivariable regression analysis, the exposure variable was clinical trial focus (eg, prematurity), and the outcomes were race and ethnicity reporting and representation of diverse cohorts. Obstetric anesthesia trials reported race and ethnicity the least frequently of all trial foci (adjusted odds ratio 0.2, 95% CI 0.08–0.48). Hypertension and obstetric anesthesia trials enrolled the lowest proportion of Black participants, and prematurity trials enrolled the lowest proportion of Latinx and Asian participants. All researchers should strive to improve measurement and reporting of demographic data as well participation of diverse cohorts.

This cross-sectional study compares an unsupervised machine learning algorithm's ability to group schools into tiers vs the US News & World Report's medical school rankings.

Christopher J. Magnani*, Brandon E. Turner, Boston, MA; Jecca R. Steinberg, Chicago, IL; Xinyuan Zhang, Seattle, WA; Ryan Brewster, Jason Qian, Alexander P. Cole, Boston, MA; Conor Driscoll, Chicago, IL; Alexander Bell, Orange, CA; Brannon T. Weeks, Boston, MA; Tina Hernandez-Boussard, James D. Brooks, Stanford, CA; Kymora Scotland, Los Angeles, CA; Quoc-Dien Trinh, Elodi J. Dielubanza, Boston, MA

Background Clinical trials form the backbone of evidence-based medicine. ClinicalTrials.gov is the world's largest clinical trial registry, and the state of clinical trials in plastic and reconstructive surgery (PRS) within that database has not been comprehensively studied. To that end, we explored the distribution of therapeutic areas that are under investigation, impact of funding on study design and data reporting, and trends in research patterns of all PRS interventional clinical trials registered with ClinicalTrials.gov. Methods Using the ClinicalTrials.gov database, we identified and extracted all clinical trials relevant to PRS that were submitted between 2007 and 2020. Studies were classified based on anatomic locations, therapeutic categories, and specialty topics. Cox proportional hazard was used to calculate adjusted hazard ratios (HRs) for early discontinuation and results reporting. Results A total of 3224 trials that included 372,095 participants were identified. The PRS trials grew at an annual rate of 7.9%. The therapeutic classes most represented were wound healing (41.3%) and cosmetics (18.1%). Funding for PRS clinical trials is largely provided through academic institutions (72.7%), while industry and US government constituted a minority. Industry-funded studies were more likely to be discontinued early than those funded by academics (HR, 1.89) or government (HR, 1.92) and to be nonblinded and nonrandomized. Academic-funded studies were the least likely to report results data within 3 years of trial completion (odds ratio, 0.87). Conclusions A gulf exists in the representation of different PRS specialties among clinical trials. We highlight the role of funding source in trial design and data reporting to identify a potential source of financial waste and to stress the need for continued appropriate oversight.

BACKGROUND AND OBJECTIVES Representative enrollment of racial and ethnic minoritized populations in biomedical research ensures the generalizability of results and equitable access to novel therapies. Previous studies on pediatric clinical trial diversity are limited to subsets of journals or disciplines. We aimed to evaluate race and ethnicity reporting and representation in all US pediatric clinical trials on ClinicalTrials.gov. METHODS We performed a cross-sectional study of US-based clinical trials registered on ClinicalTrials.gov that enrolled participants aged <18 years old between October 2007 and March 2020. We used descriptive statistics, compound annual growth rates, and multivariable logistic regression for data analysis. Estimates of US population statistics and disease burden were calculated with the US Census, Kids' Inpatient Database, and National Survey of Children's Health. RESULTS Among 1183 trials encompassing 405 376 participants, race and ethnicity reporting significantly increased from 27% in 2007 to 87% in 2018 (P < .001). The median proportional enrollment of Asian American children was 0.6% (interquartile range [IQR], 0%-3.7%); American Indian, 0% (IQR, 0%-0%); Black, 12% (IQR, 2.9%-28.4%); Hispanic, 7.1% (IQR, 0%-18.6%); and white 66.4% (IQR, 41.5%-81.6%). Asian American, Black, and Hispanic participants were underrepresented relative to US population demographics. Compared with expected proportions based on disease prevalence and hospitalizations, Asian American and Hispanic participants were most consistently underrepresented across diagnoses. CONCLUSIONS While race and ethnicity reporting in pediatric clinical trials has improved, the representative enrollment of minoritized participants remains an ongoing challenge. Evidence-based and policy solutions are needed to address these disparities to advance biomedical innovation for all children.

BACKGROUND AND OBJECTIVES: Unique ethical, epidemiological, and economic factors are barriers to performing research in children. The landscape of pediatric clinical trials, including drivers of completion and timely dissemination of results, is not well understood. We aimed to characterize the prevalence of and factors associated with early discontinuation, results reporting, and publication of pediatric clinical trials registered at ClinicalTrials.gov. METHODS: Cross-sectional analysis of clinical trials enrolling participants <18 years old registered at ClinicalTrials.gov from October 2007 to March 2020. Multivariable logistic regressions were performed to assess the association between trial characteristics and primary outcomes. Publication data were obtained through PubMed, ClinicalTrials.gov, Embase, and Scopus. RESULTS: Overall, 11.1% trials were stopped early, with recruitment failure being the predominant reason for discontinuation. Only 23.5% of completed trials reported results, and 38.8% were published within 3 years of completion. Rates of discontinuation and publication significantly improved over the study period. Among funding sources, government-sponsored trials (adjusted odds ratio [aOR], 0.72; 95% CI, 0.47-0.97) and academic trials (aOR, 0.64; 95% CI, 0.50-0.82) had lower odds of discontinuation compared with industry trials and were more likely to be published (government: aOR, 1.94 [95% CI, 1.52-2.48] academic: aOR, 1.61 [95% CI, 1.35-1.92). Academic trial investigators were the least likely to report results (aOR, 0.34; 95% CI, 0.31-0.52). CONCLUSIONS: Early discontinuation and nonreporting/nonpublication of findings remain common in registered pediatric clinical trials and were associated with funding source and other trial features. Targeted efforts are needed to support trial completion and timely results dissemination toward strengthening evidence-based pediatric medicine.

Severe immune-related adverse events (irAEs) occur in up to 60% of patients with melanoma treated with immune checkpoint inhibitors (ICIs). However, it is unknown whether a common baseline immunological state precedes irAE development. Here we applied mass cytometry by time of flight, single-cell RNA sequencing, single-cell V(D)J sequencing, bulk RNA sequencing and bulk T cell receptor (TCR) sequencing to study peripheral blood samples from patients with melanoma treated with anti-PD-1 monotherapy or anti-PD-1 and anti-CTLA-4 combination ICIs. By analyzing 93 pre- and early on-ICI blood samples and 3 patient cohorts ( n = 27, 26 and 18), we found that 2 pretreatment factors in circulation—activated CD4 memory T cell abundance and TCR diversity—are associated with severe irAE development regardless of organ system involvement. We also explored on-treatment changes in TCR clonality among patients receiving combination therapy and linked our findings to the severity and timing of irAE onset. These results demonstrate circulating T cell characteristics associated with ICI-induced toxicity, with implications for improved diagnostics and clinical management.

This quality improvement study characterizes surgical oncology trials, analyzes growth, identifies associations with early discontinuation or results reporting, and evaluates proportions of trials involving each neoplasm site.

(Abstracted from Obstet Gynecol 2022;139:821–831) The aim of this study was to characterize gynecology clinical trials over time, compare trials in various subspecialties, and analyze factors associated with early discontinuation, failure, or inadequacy to report results, as well as to publish and disseminate findings of gynecology clinical trials. The authors performed cross-sectional analysis of all gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 and their resulting publications.