Assessing microbicide acceptability: A comprehensive and integrated approach

Assessing microbicide acceptability: A comprehensive and integrated approach
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DOI:
10.1007/s10461-007-9266-z
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发表时间:
2008-03-01
期刊:
影响因子:
4.4
通讯作者:
Ruiz, Monica S.
Ruiz, Monica S.
中科院分区:
医学2区
文献类型:
--
作者:
Morrow, Kathleen M.;Ruiz, Monica S.

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需要一种安全、有效和可接受的杀微生物剂,以决定性地影响全球艾滋病流行。因此,杀微生物剂可接受性研究至关重要。为了最好地利用有限的财政资源并节省宝贵的开发时间,可接受性研究应完全整合到候选产品开发和测试的临床前和临床试验环境中。需要一种综合方法来检查理论上有效和相关的变量,以便跨研究和产品的数据可以更有效地推动该领域的发展。我们提出了一种方法,用于测量在产品开发的每个阶段与杀微生物剂可接受性相关的因素,并依赖于该领域已经建立的产品特定知识。我们讨论了行为和社会科学方法在杀微生物剂开发的各个阶段应该发挥的作用,以及在临床前和临床试验环境中进行可接受性研究时所面临的挑战。
A safe, effective, and acceptable microbicide is needed in order to decisively impact the global AIDS pandemic. As such, microbicide acceptability research is of paramount importance. In order to best utilize limited financial resources and save precious development time, acceptability studies should be fully integrated into preclinical and clinical trial contexts where candidate products are being developed and tested. An integrated approach for examining theoretically valid and relevant variables is needed so that data across studies and products can more effectively advance the field. We propose an approach for measuring factors related to microbicide acceptability in each phase of product development, and dependent on what product-specific knowledge is already established in the field. We discuss the roles that behavioral and social science methodologies should play in all phases of microbicide development, as well as the challenges faced when conducting acceptability research in the context of preclinical and clinical trial settings.