Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
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DOI：
10.1136/bmj-2023-076387
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发表时间：
2023-10-20
影响因子：
105.7
通讯作者：
Weir, Christopher J.
中科院分区：
文献类型：
--
作者：
Yap, Christina;Solovyeva, Olga;de Bono, Johann;Rekowski, Jan;Patel, Dhrusti;Jaki, Thomas;Mander, Adrian;Evans, Thomas R. Jeffry;Peck, Richard;Hayward, Kathryn S.;Hopewell, Sally;Ursino, Moreno;Rantell, Khadija Rerhou;Calvert, Melanie;Lee, Shing;Kightley, Andrew;Ashby, Deborah;Chan, An-Wen;Garrett-Mayer, Elizabeth;Isaacs, John;Golub, Robert;Kholmanskikh, Olga;Richards, Dawn;Boix, Oliver;Matcham, James;Seymour, Lesley;Ivy, S. Percy;Marshall, Lynley, V;Hommais, Antoine;Liu, Rong;Tanaka, Yoshiya;Berlin, Jordan;Espinasse, Aude;Dimairo, Munyaradzi;Weir, Christopher J.
CONSORT（报告试验的统一标准）2010声明是报告已完成随机试验的标准指南。CONSORT剂量探索扩展（DEFINE）将指南（21个新项目和19个修改项目）扩展到具有中期剂量递增或递减策略的早期剂量探索试验。此类试验通常侧重于安全性、耐受性、活性，并推荐剂量和时间表方案以用于进一步的临床开发。这些试验往往没有得到充分的报道，妨碍了它们的信息量，使证据知情的决定变得困难。CONSORT-DEFINE指南旨在为报告早期剂量探索试验制定一个国际共识驱动的指南，以促进透明度、完整性、重现性，并促进结果的解释。CONSORT-DEFINE指南提供了在早期剂量探索试验中应报告的基本项目的建议，以提高结果的清晰度、重现性、信息性和有用性。
The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote greater clarity, reproducibility, informativeness, and usefulness of results.
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DOI：
10.1093/jnci/djp079
发表时间：
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期刊：
Journal of the National Cancer Institute
影响因子：
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作者：
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发表时间：
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期刊：
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影响因子：
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作者：
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影响因子：
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