研究者的性别和临床试验在招募患者中的表现

S. Milovanov
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引用次数: 0

摘要

大多数对性别的吸引与临床试验的参与者有关。根据男女受试者的比例计算入组断裂、偏倚等指标。入学率是一个非常重要的参数,性别被认为是影响入学率的内在因素之一。作者还指出,在临床试验的某些方面,男性的患病率高于女性。很明显,调查人员在性别上也有差异,这可能会在一些参数上产生差异,入组就是其中之一。入学参数也没有太大发展。我们进一步探讨性别调查者与入组的关系。材料与方法:回顾性分析2007 - 2017年4项肿瘤学和血液学II-III期临床试验数据。研究目的:探讨不同参数的研究招募率及其随调查者性别的变化;开发新的参数和值(衍生物),可用于评价入组情况。统计分析:数据收集自可行性调查问卷,公开统计来源。结果:从研究者的性别角度显示了入组参数的取值。讨论:已经发现一些现有的和正在开发的入组参数存在统计学差异。性别对招生的影响也进行了调查。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Investigator’s gender and clinical trials performance in recruitment of patients
Mostly of attraction to gender is related with participant subjects of clinical trials. Based on percentage of subject of each gender it is calculating enrollment fracture, bias and some other indexes. Enrollment is very important parameter and genders is considering as one of the internal factors which is influencing to enrollment. Authors also marking the more prevalence of male above the female in some aspects of clinical trials. It is obviously that investigators also has a differences in gender and this could have a differences in some parameters and enrollment is one of them. Enrolment parameters also not developed very much. We stepped forward to find out the relations of gender’s investigator and the enrollment. Materials and methods: Data of four clinical trials II-III phases in oncology and hematology, conducted since 2007 to 2017 years has been used for retrospective analysis. Study objectives: to investigate the study recruitment rate using different parameters and it’s changes along with acting of gender’s of investigator; to develop new parameters and values (derivatives) which could be sensitive for evaluation of enrollment. Statistical analysis: data had been collected from feasibility questionnaires, open statistical sources. Results: It was showed the values of enrollment parameters in perspective of investigator’s gender. Discussion: Statistical differences in some existing and developed enrollment parameters has been found. Gender’s influence to enrollment also was investigated.
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