SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions) study protocol.
SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions) study protocol.
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DOI：
10.1136/bmjopen-2022-068173
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发表时间：
2023-03-29
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
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作者：
早期剂量发现（EPDF）研究对于开发新的治疗方法至关重要，直接影响化合物或干预措施能否在进一步的试验中进行研究，以确认其安全性和有效性。在《标准方案项目：介入试验建议（SPIRIT） 2013》和《随机试验综合报告标准（CONSORT） 2010》声明中存在临床试验方案和完成试验报告的指导。但是，原始报表及其扩展都没有充分涵盖EPDF试验的具体特点。DEFINE（剂量发现扩展）研究旨在提高所有疾病领域EPDF试验方案（SPIRIT-DEFINE）及其完成报告（CONSORT-DEFINE）的透明度、完整性、可重复性和解释性，以SPIRIT 2013和CONSORT 2010原始声明为基础。将对已发表的EPDF试验进行方法学审查，以确定报告中的特点和缺陷，并为候选项目的初始生成提供信息。早期的清单草案将通过对已发表文献和灰色文献的回顾、现实世界的例子分析、引用和参考文献搜索以及与包括监管机构和期刊编辑在内的国际专家的咨询来丰富。consortium - define的开发于2021年3月开始，随后是SPIRIT-DEFINE，从2022年1月开始。将运行一个涉及全球、多学科和跨部门关键利益相关者的修改后的德尔菲过程，以完善检查清单。将于2022年秋季举行的国际共识会议将最终确定两项指南扩展中包含的项目清单。本项目已获ICR临床研究委员会批准。英国卫生研究管理局证实，不需要研究伦理批准。传播战略旨在最大限度地提高指南的认识和吸收，包括但不限于在利益攸关方会议、会议、同行评议出版物以及EQUATOR网络和DEFINE研究网站上进行传播。SPIRIT-DEFINE和CONSORT-DEFINE已在赤道网络注册。
Early phase dose-finding (EPDF) studies are critical for the development of new treatments, directly influencing whether compounds or interventions can be investigated in further trials to confirm their safety and efficacy. There exists guidance for clinical trial protocols and reporting of completed trials in the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and CONsolidated Standards Of Reporting Randomised Trials (CONSORT) 2010 statements. However, neither the original statements nor their extensions adequately cover the specific features of EPDF trials. The DEFINE (DosE-FIndiNg Extensions) study aims to enhance transparency, completeness, reproducibility and interpretation of EPDF trial protocols (SPIRIT-DEFINE) and their reports once completed (CONSORT-DEFINE), across all disease areas, building on the original SPIRIT 2013 and CONSORT 2010 statements. A methodological review of published EPDF trials will be conducted to identify features and deficiencies in reporting and inform the initial generation of the candidate items. The early draft checklists will be enriched through a review of published and grey literature, real-world examples analysis, citation and reference searches and consultation with international experts, including regulators and journal editors. Development of CONSORT-DEFINE commenced in March 2021, followed by SPIRIT-DEFINE from January 2022. A modified Delphi process, involving worldwide, multidisciplinary and cross-sector key stakeholders, will be run to refine the checklists. An international consensus meeting in autumn 2022 will finalise the list of items to be included in both guidance extensions. This project was approved by ICR’s Committee for Clinical Research. The Health Research Authority confirmed Research Ethics Approval is not required. The dissemination strategy aims to maximise guideline awareness and uptake, including but not limited to dissemination in stakeholder meetings, conferences, peer-reviewed publications and on the EQUATOR Network and DEFINE study websites. SPIRIT-DEFINE and CONSORT-DEFINE are registered with the EQUATOR Network.
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DOI：
10.1016/j.jclinepi.2010.03.004
发表时间：
2010-01-01
期刊：
Open medicine : a peer-reviewed, independent, open-access journal
影响因子：
--
作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
通讯作者：
Moher, David
影响因子：
3.8
作者：
Hasson, F;Keeney, S;McKenna, H
通讯作者：
McKenna, H
影响因子：
45.3
作者：
Iasonos, Alexia;Goenen, Mithat;Bosl, George J.
通讯作者：
Bosl, George J.
影响因子：
8.8
作者：
Love SB;Brown S;Weir CJ;Harbron C;Yap C;Gaschler-Markefski B;Matcham J;Caffrey L;McKevitt C;Clive S;Craddock C;Spicer J;Cornelius V
通讯作者：
Cornelius V
影响因子：
2.7
作者：
Sertkaya, Aylin;Wong, Hui-Hsing;Beleche, Trinidad
通讯作者：
Beleche, Trinidad