关键词: Delphi process decentralized clinical trials dementia prevention recommendations remote clinical trials

Mesh : Humans Dementia / prevention & control drug therapy Clinical Trials as Topic Consensus Delphi Technique Research Design / standards

来  源:   DOI:10.1002/alz.13891   PDF(Pubmed)

Abstract:
Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field.
A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations.
Overall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection.
These recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention.
Clinical trials of medication have begun adopting decentralized approaches. Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention. The present report provides consensus-based expert recommendations for decentralized clinical trials for dementia prevention.
摘要:
背景:最近技术功能和使用的增长促使人们对痴呆症远程或分散临床试验的潜力越来越感兴趣。分散的药物试验有许多潜在的好处,但我们目前缺乏在痴呆症领域提供它们的具体建议.
方法:改进的Delphi方法聘请专家小组为开展预防痴呆的分散药物试验提供建议。在痴呆症试验中具有专业知识的研究人员和临床医生工作组进一步完善了建议。
结果:总体而言,这些建议支持在痴呆预防中开展分散试验,前提是纳入足够的安全性检查和平衡.共提出40项建议,跨越分散临床试验的各个方面,包括安全,配药,结果评估,和数据收集。
结论:这些建议提供了一个可访问的,用于预防痴呆症的远程药物试验的设计和实施的实用指南。
结论:药物临床试验已经开始采用分散的方法。该领域的研究人员缺乏关于在痴呆症预防中使用分散试验方法的适当情况和框架的指导。本报告为分散的痴呆症预防临床试验提供了基于共识的专家建议。
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