确定已批准的肿瘤药物的最佳使用

Gauthier Bouche, Duncan Gilbert, Matteo Quartagno, Hakim-Moulay Dehbi, Sophie Merrick, Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, Richard Stephens, Mahesh Parmar, Ruth E Langley
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引用次数: 0

摘要

优化已批准药物的使用需要来自批准后试验的证据,这些试验调查了药物使用的变化。确定最佳的药物使用,超出了主导的学术努力,即进行试验,以确定有效的低剂量新药。其他使用比标准剂量更少、相似或更多药物的重要治疗方法需要在临床试验中进行测试,以最大限度地利用这些药物。关于生存结局的试验目标差异很大;一些人的目标是优越,另一些人的目标是同等暴露或不自卑。本个人观点旨在告知学术试验人员如何构思和优先考虑旨在确定药物最佳使用的问题,同时考虑到患者、临床医生和试验资助者的观点,以最大限度地提高成功交付的机会并对全球患者产生影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Determining the optimal use of approved drugs in oncology
Optimising the use of approved drugs requires evidence from post-approval trials that investigate variations of their use. Determining optimal drug use goes beyond the dominant, academic effort to conduct trials to identify effective lower doses of new drugs. Other important therapeutic approaches that use either less, similar, or more drug than the standard dose need testing in clinical trials, to get the most out of these drugs. Trial objectives on survival outcomes vary greatly; some aim for superiority, others for equivalent exposure or non-inferiority. This Personal View aims to inform academic trialists in how to conceive and prioritise questions aimed at determining the optimal use of drugs, taking into account the perspectives of patients, clinicians, and trial funders, to maximise the chances of successful delivery and impact for patients globally.
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