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'You can save time if…'—A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa

机译:“如果……,您可以节省时间” —关于减慢撒哈拉以南非洲地区临床试验的内部因素的定性研究

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摘要

BackgroundThe costs, complexity, legal requirements and number of amendments associated with clinical trials are rising constantly, which negatively affects the efficient conduct of trials. In Sub-Saharan Africa, this situation is exacerbated by capacity and funding limitations, which further increase the workload of clinical trialists. At the same time, trials are critically important for improving public health in these settings. The aim of this study was to identify the internal factors that slow down clinical trials in Sub-Saharan Africa. Here, factors are limited to those that exclusively relate to clinical trial teams and sponsors. These factors may be influenced independently of external conditions and may significantly increase trial efficiency if addressed by the respective teams.
机译:背景技术与临床试验相关的费用,复杂性,法律要求和修订数量不断增加,这对试验的有效进行产生了负面影响。在撒哈拉以南非洲,由于能力和资金限制,这种情况更加恶化,这进一步增加了临床试验人员的工作量。同时,试验对于改善这些地区的公共卫生至关重要。这项研究的目的是确定减慢撒哈拉以南非洲地区临床试验的内部因素。在此,因素仅限于与临床试验团队和申办者有关的因素。这些因素可能不受外部条件的影响,并且如果由各个团队解决,可能会大大提高审判效率。

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