Abstract：
OBJECTIVE: 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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
目的：临床试验在评估药物治疗的安全性和有效性方面发挥着关键作用。在放射学造影剂的临床试验中，解决参与者的性别分布对于确保试验结果的普遍性至关重要。先前的研究强调了人口因素的影响，尤其是性,关于治疗反应，强调临床试验中公平代表性的必要性。我们的研究目的是确定放射造影剂临床试验中参与者的性别分布。
方法：我们的回顾性研究包括1990年至2017年间进行的65项临床试验，这些临床试验在clinicaltrials.gov上进行了全面审查，包括单独搜索所有FDA批准的造影剂。收集的数据包括FDA批准的年份，参与者的数量,性别分布，试验地点,试验阶段,和研究类型。评估者之间的验证确保了数据的准确性。
结果：我们的分析显示试验参与者的性别分布存在波动。在大多数年份，男性的入学率超过了女性，在最近的审判中转向更公平的代表性。在美国进行的试验中，女性的入学率更高。第一阶段试验的代表性最平衡，而IV期试验的性别差异最大。
结论：在所有试验中，女性占入学率的47.3%[7016名总入学率中的3316名]。在所研究的65项试验中，有44项试验中男性超过女性，在19项试验中，女性人数超过男性，在2项试验中，性别之间的纳入是相等的。虽然在所有试验中观察到的性别分布代表了参与者的公平代表性，个体试验水平的性别分布差异较大,有可能限制结果的普遍性.
方法：我们的回顾性研究包括1990年至2017年间进行的65项临床试验，这些临床试验在clinicaltrials.gov上进行了全面审查，包括单独搜索所有FDA批准的造影剂。收集的数据包括FDA批准的年份，参与者的数量,性别分布，试验地点,试验阶段,和研究类型。评估者之间的验证确保了数据的准确性。
结果：我们的分析显示试验参与者的性别分布存在波动。在大多数年份，男性的入学率超过了女性，在最近的审判中转向更公平的代表性。在美国进行的试验中，女性的入学率更高。第一阶段试验的代表性最平衡，而IV期试验的性别差异最大。
结论：在所有试验中，女性占入学率的47.3%[7016名总入学率中的3316名]。在所研究的65项试验中，有44项试验中男性超过女性，在19项试验中，女性人数超过男性，在2项试验中，性别之间的纳入是相等的。虽然在所有试验中观察到的性别分布代表了参与者的公平代表性，个体试验水平的性别分布差异较大,有可能限制结果的普遍性.
