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Language: search.filters.language.EnglishSubject: search.filters.subject.Clinical Trials

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  • Item type:Publication,
    Sex Disparities in Spine Surgeon Leadership of Clinical Trials for Degenerative Spine Disease Research Open PDF 
    (Ovid Technologies (Wolters Kluwer Health), 2025-08-28)
    Silvestre, Jason
    ;
    Walker, Jasmine J.
    ;
    Kang, James D.
    ;
    Ravinsky, Robert A.
    ;
    Lawrence, James P.
    Introduction: Despite increasing awareness, women remain underrepresented in academic spine surgery. This study assessed whether women were equitably represented among spine surgeon PIs of clinical trials for degenerative spine disease research. Methods: This was a retrospective cohort study of spine surgeon principal investigators (PIs) in the United States (2015 to 2022). ClinicalTrials.gov was queried for the most common diagnoses and surgeries for degenerative spine diseases. Characteristics of spine surgeon PIs were collected from academic profiles. Participation-to-prevalence ratios (PPRs) were calculated for men and women PIs relative to their prevalence among spine surgery faculty at accredited training programs. A PPR of 0.8 to 1.2 indicated equitable sex representation. A PPR <0.8 was defined as underrepresentation and >1.2 as overrepresentation. Results: In total, 129 spine surgeon PIs of 91 clinical trials were included in this study. Overall, there were 125 male (97%) and four female (3%) spine surgeon PIs. Overall, women were underrepresented among spine surgeon PIs (PPR = 0.64), whereas men had equitable representation (PPR = 1.02). From 2015 to 2018, female spine surgeons were underrepresented (PPR = 0.33), but achieved equitable representation from 2019 to 2022 (PPR = 0.95). Male spine surgeons had consistently equitable representation across the study period (PPR range 1.00 to 1.03). Women had equitable representation at assistant (PPR = 1.08) and associate (PPR = 0.31) professor ranks, but were underrepresented at the full professor rank (PPR = 0). PIs were funded by industry (54%), academic institution (44%), and US Federal (2%) sources. No differences were observed in funding sources by sex ( P = 0.36). Discussion: There are a limited number of female spine surgeon PIs for degenerative spine disease clinical trials, which may have negative implications on the vitality of the specialty moving forward. Future investigations are needed to understand the barriers women face in obtaining clinical trial leadership positions.
  • Item type:Publication,
    Time trends, disease patterns and gender imbalance in the top 100 most cited articles in ophthalmology Open PDF 
    (2019)
    Heng Wong, M.Y.
    ;
    Tan, N.Y.Q.
    ;
    Sabanayagam, C.
    We analysed the 100 top cited articles in ophthalmology to identify and characterise the most influential articles of the past four decades. Two independent investigators searched the Scopus database to determine the 100 most frequently cited articles in ophthalmology (T100-Eye) and general non-ophthalmology journals (T100-Gen) published from 1975 to December 2017. The T100-Eye list consisted of 83 original articles and 17 reviews, and the number of citations ranged from 582 to 2833. Seventy-eight of these articles were published in three journals alone (impact factor (IF): 5.05-8.2), led by the Archives of Ophthalmology. The T100-Gen list consisted of 84 original articles and 16 reviews and the number of citations ranged from 358 to 3272. Forty-five of these articles were published in four journals alone (IF: 9.66-72.41). In both lists, majority of the first authors were from the USA (T100-Eye, n=80; T100-Gen, n=66), and were men (n=76 in T100-Eye; n=72 in T100-Gen). With regard to the article type, in the T100-Eye, among the 83 original research articles, most were randomised controlled trials (n=26) or clinical observational studies related to description of a new condition or new management (n=26). In the T100-Gen, of the 84 original research articles, many were clinical observational studies (n=27) or basic science research (n=26). In both lists, the most frequently examined diseases were age-related macular degeneration, diabetic retinopathy and glaucoma. Our analysis reveals landmark articles, trends and medical advancements in ophthalmology over the past four decades. It also highlights gender disparity and influence of the USA in seminal ophthalmic research. © 2019 Article author(s).
  • Item type:Publication,
    Gender, Racial, and Academic Authorship Diversity in the Otolaryngology Clinical Trial Literature Open PDF 
    (2024)
    Yang, H.-H.
    ;
    Huynh, J.D.
    ;
    Moffatt, C.
    ;
    Evans, L.K.
    ;
    Bommakanti, K.
    Objective: To investigate the state and trajectory of gender, racial, and academic authorship diversity in the otolaryngology clinical trial literature over the past 2 decades. Study Design: Bibliometric analysis. Setting: Otolaryngology clinical trial literature. Methods: Clinical trials published in the 9 major otolaryngology journals between 2000 and 2020 were included. The gender, race, and academic seniority of the first, senior, and corresponding authors were recorded for each trial. Multivariable regression models assessed the temporal trajectory of authorship diversity over time and the disparity in citations across author characteristics. Models adjusted for relevant confounders pertaining to publication environment and study design. Results: Among 2117 trials, first, senior, and corresponding authors have been predominantly White (60%-64%), male (76%-80%), and attending physicians (63%-69%). Trials led by Black (<1%) and Hispanic (<5%) authors were severely underrepresented. Over time, the representation of female (adj. β 0.8%, 95% CI [0.5%, 1.1%] per year), Asian (1.0% [0.7%, 1.3%] per year), and MD resident (0.4% [0.1%, 0.7%] per year) first authorship increased, but representation of female (0.2% [−0.1%, 0.5%] per year), Black (0% [−0.03%, 0.02%] per year), Hispanic (−0.2% [−0.33%, −0.02%] per year) senior authorship remained persistently low. Asian-led trials were cited significantly less compared to White-led trials even after adjusting for study design and publication year (aIRR 0.82 [0.73, 0.92]). Conclusions: Despite promising signs of improving authorship diversity over time, persistent underrepresentation of female, Black, Hispanic senior authorship underscore the need for additional efforts to diversify the otolaryngology clinical science workforce. © 2024 American Academy of Otolaryngology–Head and Neck Surgery Foundation.
  • Item type:Publication,
    Ending Gender Inequality in Cardiovascular Clinical Trial Leadership: JACC Review Topic of the Week Open PDF 
    (2021)
    Van Spall, Harriette G. C.
    ;
    Lala, Anuradha
    ;
    Deering, Thomas F.
    ;
    Casadei, Barbara
    ;
    Zannad, Faiez
    Women are under-represented as leaders of cardiovascular randomized controlled trials, representing 1 in 10 lead authors of cardiovascular trials published in high-impact journals. Although the proportion of cardiovascular specialists who are women has increased in recent years, the proportion of cardiovascular clinical trialists who are women has not. This gap, underpinned by systemic sexism, has not been adequately addressed. The benefits of diverse randomized controlled trial leadership extend to patients and professionals. In this position statement, we present strategies adopted by some organizations to end gender inequality in research leadership. We offer an actionable roadmap for early-career researchers, scientists, academic institutions, professional societies, trial sponsors, and journals to follow, with the goal of harnessing the strength of women and under-represented groups as research leaders and facilitating a just culture in the cardiovascular clinical trial enterprise.
  • Item type:Publication,
    Gender disparities in coronavirus disease 2019 clinical trial leadership Open PDF 
    (2021)
    Cevik, Muge
    ;
    Haque, Syed Arefinul
    ;
    Manne-Goehler, Jennifer
    ;
    Kuppalli, Krutika
    ;
    Sax, Paul E.
    OBJECTIVES: To compare the gender distribution of clinical trial leadership in coronavirus disease 2019 (COVID-19) clinical trials. METHODS: We searched https://clinicaltrials.gov/ and retrieved all clinical trials on COVID-19 from 1 January 2020 to 26 June 2020. As a comparator group, we have chosen two fields that are not related to emerging infections and infectious diseases: and considered not directly affected by the pandemic: breast cancer and type 2 diabetes mellitus (T2DM) and included studies within the aforementioned study period as well as those registered in the preceding year (pre-study period: 1 January 2019 to 31 December 2019). Gender of the investigator was predicted using the genderize.io application programming interface. The repository of the data sets used to collect and analyse the data are available at https://osf.io/k2r57/. RESULTS: Only 27.8% (430/1548) of principal investigators among COVID-19-related studies were women, which is significantly different compared with 54.9% (156/284) and 42.1% (56/133) for breast cancer (p < 0.005) and T2DM (p < 0.005) trials over the same period, respectively. During the pre-study period, the proportion of principal investigators who were predicted to be women were 49.7% (245/493) and 44.4% (148/333) for breast cancer and T2DM trials, respectively, and the difference was not statistically significant when compared with results from the study period (p > 0.05). CONCLUSION: We demonstrate that less than one-third of COVID-19-related clinical trials are led by women, half the proportion observed in non-COVID-19 trials over the same period, which remained similar to the pre-study period. These gender disparities during the pandemic may not only indicate a lack of female leadership in international clinical trials and involvement in new projects but also reveal imbalances in women's access to research activities and funding during health emergencies.