David McEvoy , Ahmad Abu-Omar , Mehwish Hussain , Maham Vaqar , Carol Dong , Quratulain Sahi , Faisal Khosa
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Our study aim was to determine the sex distribution of enrollees in clinical trials of radiologic contrast agents.</p></div><div><h3>Methods</h3><p>Our retrospective study included a total of 65 clinical trials conducted between 1990 and 2017 identified on <span>clinicaltrials.gov</span><svg><path></path></svg> after a comprehensive review including searching individually for all FDA approved contrast agents. Data collected included the year of FDA approval, the number of participants, sex distribution, trial location, trial phase, and study type. Inter-rater validation ensured data accuracy.</p></div><div><h3>Results</h3><p>Our analysis revealed fluctuations in sex distribution of trial enrollees. Enrollment of males exceeded females in most years, with a shift towards a more equitable representation in recent trials. Trials conducted in the United States had a higher rate of enrollment by females. Phase I trials had the most balanced representation, whereas Phase IV trials had the highest sex disparity.</p></div><div><h3>Conclusion</h3><p>Across all trials, females made up 47.3 % of enrollees [3316 out of 7016 total enrollees]. Enrollment of males exceeded females in 44 of the 65 trials studied, females outnumbered males in 19 trials, and enrollment was equal between the sexes in 2 trials. While the sex distribution observed across all trials represents an equitable representation of enrollees, the wide variance of sex distribution at the level of individual trials has the potential to limit the generalizability of results.</p></div>","PeriodicalId":50680,"journal":{"name":"Clinical Imaging","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0899707124001244/pdfft?md5=c8adb645e6813288e03cfefe20563ba4&pid=1-s2.0-S0899707124001244-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Sex distribution in clinical trials of radiologic contrast agents: A 27-year review\",\"authors\":\"David McEvoy , Ahmad Abu-Omar , Mehwish Hussain , Maham Vaqar , Carol Dong , Quratulain Sahi , Faisal Khosa\",\"doi\":\"10.1016/j.clinimag.2024.110194\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><p>Clinical trials play a pivotal role in assessing the safety and efficacy of medical therapies. Addressing sex distribution among enrollees in clinical trials of radiologic contrast agents is essential for ensuring the generalizability of trial outcomes. Previous research has highlighted the influence of demographic factors, particularly sex, on treatment responses, emphasizing the need for equitable representation in clinical trials. Our study aim was to determine the sex distribution of enrollees in clinical trials of radiologic contrast agents.</p></div><div><h3>Methods</h3><p>Our retrospective study included a total of 65 clinical trials conducted between 1990 and 2017 identified on <span>clinicaltrials.gov</span><svg><path></path></svg> after a comprehensive review including searching individually for all FDA approved contrast agents. Data collected included the year of FDA approval, the number of participants, sex distribution, trial location, trial phase, and study type. Inter-rater validation ensured data accuracy.</p></div><div><h3>Results</h3><p>Our analysis revealed fluctuations in sex distribution of trial enrollees. Enrollment of males exceeded females in most years, with a shift towards a more equitable representation in recent trials. Trials conducted in the United States had a higher rate of enrollment by females. Phase I trials had the most balanced representation, whereas Phase IV trials had the highest sex disparity.</p></div><div><h3>Conclusion</h3><p>Across all trials, females made up 47.3 % of enrollees [3316 out of 7016 total enrollees]. Enrollment of males exceeded females in 44 of the 65 trials studied, females outnumbered males in 19 trials, and enrollment was equal between the sexes in 2 trials. While the sex distribution observed across all trials represents an equitable representation of enrollees, the wide variance of sex distribution at the level of individual trials has the potential to limit the generalizability of results.</p></div>\",\"PeriodicalId\":50680,\"journal\":{\"name\":\"Clinical Imaging\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2024-06-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0899707124001244/pdfft?md5=c8adb645e6813288e03cfefe20563ba4&pid=1-s2.0-S0899707124001244-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Imaging\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0899707124001244\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Imaging","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0899707124001244","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
Sex distribution in clinical trials of radiologic contrast agents: A 27-year review
Purpose
Clinical trials play a pivotal role in assessing the safety and efficacy of medical therapies. Addressing sex distribution among enrollees in clinical trials of radiologic contrast agents is essential for ensuring the generalizability of trial outcomes. Previous research has highlighted the influence of demographic factors, particularly sex, on treatment responses, emphasizing the need for equitable representation in clinical trials. Our study aim was to determine the sex distribution of enrollees in clinical trials of radiologic contrast agents.
Methods
Our retrospective study included a total of 65 clinical trials conducted between 1990 and 2017 identified on clinicaltrials.gov after a comprehensive review including searching individually for all FDA approved contrast agents. Data collected included the year of FDA approval, the number of participants, sex distribution, trial location, trial phase, and study type. Inter-rater validation ensured data accuracy.
Results
Our analysis revealed fluctuations in sex distribution of trial enrollees. Enrollment of males exceeded females in most years, with a shift towards a more equitable representation in recent trials. Trials conducted in the United States had a higher rate of enrollment by females. Phase I trials had the most balanced representation, whereas Phase IV trials had the highest sex disparity.
Conclusion
Across all trials, females made up 47.3 % of enrollees [3316 out of 7016 total enrollees]. Enrollment of males exceeded females in 44 of the 65 trials studied, females outnumbered males in 19 trials, and enrollment was equal between the sexes in 2 trials. While the sex distribution observed across all trials represents an equitable representation of enrollees, the wide variance of sex distribution at the level of individual trials has the potential to limit the generalizability of results.
期刊介绍：
The mission of Clinical Imaging is to publish, in a timely manner, the very best radiology research from the United States and around the world with special attention to the impact of medical imaging on patient care. The journal''s publications cover all imaging modalities, radiology issues related to patients, policy and practice improvements, and clinically-oriented imaging physics and informatics. The journal is a valuable resource for practicing radiologists, radiologists-in-training and other clinicians with an interest in imaging. Papers are carefully peer-reviewed and selected by our experienced subject editors who are leading experts spanning the range of imaging sub-specialties, which include:
-Body Imaging-
Breast Imaging-
Cardiothoracic Imaging-
Imaging Physics and Informatics-
Molecular Imaging and Nuclear Medicine-
Musculoskeletal and Emergency Imaging-
Neuroradiology-
Practice, Policy & Education-
Pediatric Imaging-
Vascular and Interventional Radiology
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