Rate of patient’s Recruitment and Recruitment Derivatives from the Perspectives of Internal factors - Protocol Study Nosology, Experience of Investigators and Potential Patient’s Pool of Sites

S. Milovanov
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Abstract

The recruitment as a process found by many authors to be undergoing of many factors. There is a factors which are decreasing the recruitment and last data is reporting up to 80% trials failed due to law or even absence of recruitment on level of sites. But the factors are differently changing the recruitment. The final number of recruitment is static figure very well known, there is also known speed of recruitment which is calculating in the start of the study and these parameters along with others is quantitative evaluation of recruitment. We investigated the rate of recruitment in the light of some factors using parameters reflecting the recruitment progress of recruitment. Materials and Methods: Retrospective analysis of data of four clinical trials II-III phases in oncology and hematology, conducted since 2007 to 2017 years. Study objectives: to investigate the study recruitment rate using different parameters and its changes along with acting of internal factors; to develop new parameters which could be sensitive for evaluation of factor’s action. Statistical analysis: data had been collected from feasibility questionnaires, open statistical sources. Results: It was determined rate of recruitment and its derivatives where was acting an internal factor. Discussion: Recruitment been undergone the internal factors. The way of action is multidirectional and could boost the recruitment and in opposite to decrease one and knowing it is important in success of recruitment and clinical trial itself eventually
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从内部因素的角度看患者的招募率和招募衍生品——方案研究、分科学、研究者的经验和潜在患者的地点池
许多作者发现,招聘是一个经历多种因素的过程。有一个因素正在减少招募,最新数据显示,多达80%的试验由于法律或甚至没有招聘而失败。但这些因素正在改变招聘。招聘的最终数量是众所周知的静态数字,还有已知的招聘速度,这是在研究开始时计算的,这些参数以及其他参数是对招聘的定量评估。我们利用反映招聘进度的参数,结合一些因素对招聘率进行调查。材料与方法:回顾性分析2007年至2017年在肿瘤学和血液学领域进行的4项II-III期临床试验的数据。研究目的:考察不同参数下的招生率及其随内部因素作用的变化情况;为评价因子的作用,开发新的敏感参数。统计分析:数据收集自可行性调查问卷,公开统计来源。结果:确定了招募率及其衍生物作为内部因素。讨论:招聘经历的内部因素。其作用方式是多向的,既能促进招募,又能减少招募,最终对招募的成功和临床试验本身都有重要意义
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