Institute of Cancer Research, London SM2 5NG, UK.
Royal Marsden NHS Foundation Trust, London, UK.
BMJ. 2023 Oct 20;383:e076387. doi: 10.1136/bmj-2023-076387.
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.
CONSORT（CONsolidated Standards Of Reporting Trials）2010 声明是报告已完成随机试验的标准指南。CONSORT 剂量发现扩展（DEFINE）将指导（新增 21 项和修改 19 项）扩展到具有中期剂量递增或递减策略的早期阶段剂量发现试验。此类试验通常侧重于安全性、耐受性、活性，并为进一步的临床开发推荐给药和计划方案。这些试验往往报告不足，阻碍了其信息性，并使证据支持的决策变得困难。CONSORT-DEFINE 指南旨在为早期阶段剂量发现试验制定国际共识驱动的报告指南，以提高透明度、完整性、可重复性，并有助于解释结果。CONSORT-DEFINE 指南为早期阶段剂量发现试验中应报告的基本项目提供了建议，以提高结果的清晰度、可重复性、信息量和有用性。
