Infor- ICH E17 Guideline 3 mation about them should also be collected during the confirmatory trial for evaluation of their impact on treatment effects. 内在、外在因素,尽早考虑——探索性阶段 3. MRCTs are planned under the assumption that the treatment effect applies to the entire target ...
The National Medical Products Administration of China has been implementing ICH E17, which describes the general principles for planning and designing of multi-regional clinical trials (MRCTs), yet there are several ambiguities in the execution and conduct remains in China or East Asia. In specific...
ICH协调指导原则E17 General principle on planning and Designing Multi-Regional Clinical Trials.pdf,INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GENERAL PRINCIPLES FOR PLANNING
Announcement No. 50 of NMPA, 2018, Announcement on the Adjustment of Review and Approval Procedures for Clinical Trials of Drugs. Registration Scope Clinical trial application (CTA) for drug market approval within the territory of the People’s Republic of China. E...
This finding confirms animal and human research suggesting the importance of septal function to the right ventricle and implies that changes in septal function could herald RV dysfunction. Trial registry ClinicalTrials.gov; No.NCT00005487; URLwww.clinicaltrials.gov 展开 ...
clinical target volume, heart, left lung, right lung, and spinal cord from planning computed tomography to cone-beam CT. To improve the traditional image registration method’s performance, we used a regional deformable framework based on the narrow-band mapping, which can mitigate the effect of...
根据2014 年发布的《欧盟临床试验法规》(EU Clinical Trial Regulation),通俗语言摘要已成为一项标准要求。多年来,已有多个针对此类摘要的内容和风格的不同指南陆续发布。2021 年,EudraLex 第 10 卷刊登了简明摘要良好实践建议 (GLSP) 实用手册。 GLSP 介绍了撰写通俗语言摘要所需的综合技能。具体包括以下能力: ...
背景 一家總部位於中國、專注于創新新型免疫療法的生物技術申辦方,曾在一項於美國地區開展的針對晚期/轉移
一家总部位于中国、专注于创新新型免疫疗法的生物技术申办方,曾在一项在美国地区开展的针对晚期/转移性实体肿瘤患者的I期研究中遭遇了重大挫折。为了解决这一挑战,申办方最终寻求Novotech的帮助,委托他们进行全面专业的临床前和全方位CRO操作,以解救项目困境。
One of the challenges to multi-regional clinical trials (MRCT) is how to utilize the data obtained from other regions within the entire trial to help make local approval decisions. In addition to the global efficacy, the evidence of consistency in treatment effects between the local region and...