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发展中国家临床试验招募面临的挑战:分枝杆菌研究中心的经验。

The challenges of recruitment in clinical trials in developing countries: the Mycetoma Research Centre experience.

机构信息

Mycetoma Research Centre, University of Khartoum, Khartoum, Sudan.

Institute for Endemic Diseases, University of Khartoum, Khartoum, Sudan.

出版信息

Trans R Soc Trop Med Hyg. 2021 Apr 14;115(4):397-405. doi: 10.1093/trstmh/traa165.

Abstract

Mycetoma is a chronic disease caused either by fungi (eumycetoma) or bacteria (actinomycetoma). Treatment remains suboptimal and based on personal clinical experience. Recently, the Mycetoma Research Centre (MRC), a WHO Collaborating Centre on mycetoma, began the first-ever double-blind clinical trial. Here, we report the challenges and barriers faced in the recruitment and retention of patients in the MRC experience. Patient recruitment and retention are critical determinants of clinical trial success and yet a substantial number of trials fail to reach their recruitment goals. Recruitment challenges are identified throughout the different stages of the clinical trial, starting from planning, participant screening and intervention, through to retaining participants for the entire study duration. The MRC made efforts to address these challenges to ensure the constant flow of patients. The recruitment committee at the MRC conducted training workshops for the medical staff in the endemic areas, along with regular meetings with health authorities and local leaders. Moreover, telemedicine technology was used to examine patients in endemic areas. Challenges and barriers facing clinical trial conduct need to be examined thoroughly to ensure actionable, evidence-based recommendations for improving patient recruitment and retention. In conclusion, effective patient recruitment and retention are based on three pillars, which are proper clinical trial design and protocol development, realistic and feasible trial site selection, and objective communication with the trial stakeholders.

摘要

足菌肿是一种由真菌(外生菌)或细菌(放线菌)引起的慢性疾病。目前的治疗方法仍然不尽人意,主要基于个人临床经验。最近,世界卫生组织(WHO)合作中心——足菌肿研究中心(MRC)开始进行首例双盲临床试验。在此,我们报告在 MRC 经验中招募和保留患者方面所面临的挑战和障碍。患者招募和保留是临床试验成功的关键决定因素,但仍有相当数量的试验未能达到其招募目标。招募挑战在临床试验的不同阶段都有出现,从规划、参与者筛选和干预,到在整个研究期间留住参与者。MRC 努力解决这些挑战,以确保患者的持续供应。MRC 的招募委员会为流行地区的医务人员举办了培训研讨会,并定期与卫生当局和地方领导人举行会议。此外,还使用远程医疗技术来检查流行地区的患者。需要彻底检查临床试验实施所面临的挑战和障碍,以确保为改善患者招募和保留提供切实可行的、基于证据的建议。总之,有效的患者招募和保留基于三个支柱,即适当的临床试验设计和方案制定、现实可行的试验地点选择以及与试验利益相关者的客观沟通。

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