Why Do We Need Diversity Plans In Clinical Trials?
1.What is a Diversity Plan? In order to know if a new drug or medical device works in specific patient population, we need to have data generated from clinical research….
Continue reading1.What is a Diversity Plan? In order to know if a new drug or medical device works in specific patient population, we need to have data generated from clinical research….
Continue readingThere has been growing interest in implementation of pragmatic approaches in clinical trials. Especially for enhancement cancer research conduct including regulatory communications and ultimately patient care, where the use of…
Continue reading试验委托者可以透过CTIS系统线上单一提交临床试验的资料,即可向最多30个欧盟成员国申请核准进行临床试验。 欧盟《临床试验法规》(CTR)于2014年5月27日发布,取代了《2001/2004年临床试验指令》。CTR的实施旨在简化和统一临床试验的提交、评估和监督流程,并提高信息的公开透明性,为公众和医疗保健专业人员提供全面的临床试验信息。 新法规设定了为期三年的过渡期(2022年2月至2025年2月),并要求在2023年2月1日之后,所有初始临床试验申请(Initial CTA)必须按照CTR要求通过临床试验信息系统(CTIS)提交。 CTIS的用户可以注册为管理员或业务员,管理员负责管理组织的用户和分配角色,业务员则负责执行临床试验。管理员分为中级和高级,高级管理员(Sponsor Administrator)需获得欧洲药品管理局(EMA)验证,有权限为其他用户分配角色和权限。中级管理员(CT Administrator)由高级管理员分配,适用于较小的试验委托者用户,无需EMA验证。 CTIS包括两大区域: 公众可以通过CTIS公共网站获取关键且透明的临床试验信息。 在CTIS中,有三种类型的申请: 新的初始CTA可以是单国或多国的申请。在增加成员国的申请中,申请方需要选择报告成员国(RMS)。成员国需在3天内回复是否同意成为报告成员国(RMS)。 初始临床试验申请(Initial CTA)流程 提交初始CTA时,申请者需考虑以下几点: 初始CTA包含四个主要部分: 上市授权申请人需提交风险管理计划(RMPs)。 撤回和重新提交初始CTA 过渡期临床试验 2025年2月1日之前,所有正在进行的临床试验需根据CTR通过CTIS重新提交。EudraCT将继续用于报告CT指令和全球试验结束。若满足以下任一条件,申办者必须将试验从EudraCT过渡到CTIS: 符合以下标准的试验也需过渡到CTIS: 为将试验从EudraCT过渡到CTIS,需提交标记为过渡期试验的初始CTA,完成『表格』、『成员国』、『第一部分』 和『第二部分』。 成员国(MSCs)可以选择在60天或更短时间内授权试验。然而,MSCs可能会针对过渡期试验的申请提出RFI(最长106天的审查期,某些类型的试验用药品可能更长)。建议申办者在过渡期结束前尽早将其过渡期试验提交到CTIS。 医疗设备申请 CTIS暂不适用于医疗设备,预计在2025年底或2026年初实施。
Continue readingCTIS supports clinical trials sponsors to apply for clinical trial authorisation in up to 30 European Union (EU) countries (member of states) with a single application process. Clinical Trials (CTs)…
Continue readingRecently I attended the bi-annual meeting organised by the Institute of Clinical Research – GCP Forum. We had the pleasure to have the senior GCP inspector at the MHRA, Andrew…
Continue readingThe last year has been very successful for our team. We are grateful that in such challenging times for many businesses, we had the opportunity to set up and manage…
Continue readingFDA have released a final guidance regarding informed consent requirements for clinical trials. This guidance is applicable not only for medicinal products but for medical devices too. In this summery…
Continue readingAll of us working in clinical trials set up are acutely aware of the phrase ‘… so you can just do the submission and we will handle the rest’. Many…
Continue readingThere is an ongoing public consultation by the World Health Organization which aims to update its guidelines on clinical trials. There are some really good recommendations in the draft guideline…
Continue readingThere is a growing number of medical device clinical trials globally. While they have lots of similarities in terms of study design and documentations to drug clinical trials, medical device…
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