必赢亚娱乐官网(中国)有限公司

您当前位置:奥咨达医疗器械服务集团 >> 资讯中心 >> 行业信息 >> 浏览文章

【奥译言】临床试验的创新思路--移动技术的应用

阅读: 2017年06月28日

【奥译言】临床试验的创新思路--移动技术的应用


临床试验改革小组(CTTI)是由杜克大学与FDA联合组建的官方-私人合作关系的组织,该组织于本周一针对移动技术衍生的创新临床试验终点的开发提出了新的建议。


该移动技术对收集临床受试者日常生活的客观测量提供了新的途径。


该创新终点的使用被合作方定义为“一个先前不曾被获取的全新终点”,或“现有终点可以通过新的或更好的方式测量”,尽管此创新终点的应用拥有巨大的潜力,但仍需要长足的发展来推动该创新终点的应用,以更好得支撑法规批准和标签要求,当前其符合路径的要求尚不完善。


FDA药品评估和研究中心主任Janet Woodcock提到“技术衍生终点为获取患者在“真实世界”中的体验信息提供了便利”。“这些工具对获取数据有巨大的潜力,获取后的数据可以用来开发终点和对患者人群进行治疗评估。”


推荐


CTTI对优化创新终点的选择提供了3条建议,并且对创新终点开发过程的实践途径提出了5条建议。


依据最优化原则,CTTI建议企业关注那些对患者有意义的测量数据上,在选取一个结果评定后选择一个适宜的移动设备,并且运用系统方法来识别此创新终点,因为其可能是一个耗时且资源密集的过程。


CTTI也推荐建立有关以下项目的行业标准:1)术语,2)移动设备捕获数据的搜集和报道,3)有关核心算法的透明要求,该算法用来将数据转换为生理学和医学的有用终点。

该合伙方也鼓励药品和医疗器械赞助商在关键试验期使用创新终点,以推动在试验性新药应用或临床试验器械豁免评审期间与FDA的相互交流。


虽然需要深思熟虑的选择和标准化的措施,但申办商和学术研究者应将移动技术应用到现有的研究和试验中,以确定与其他评估方式相比,何种创新终点可提供增量效用。CTTI建议优先单独使用创新终点在内的探索式终点来开展临床试验。

奥咨达服务


FDA 510K 申报服务和周期(含工厂注册和合同范围内产品列名)
FDA De Novo
FDA MD 预提交(Pre-submission)申报服务和周期
FDA PMA申报服务和周期
FDA产品列名 申报服务和周期
FDA豁免510K-服务


英语原文  


Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations


Posted 26 June 2017 

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology.


Such mobile technology can offer new ways to collect objective measurements of clinical trial participants as they go about their daily lives.


And though the use of such novel endpoints, which the partnership defines as: "new endpoints that have not previously been possible to assess," or "existing endpoints that can be measured in new and possibly better ways," has significant potential, substantial development "will be required to facilitate the use of mobile technology-derived novel endpoints to support regulatory approval and labeling claims, as the pathway for acceptance is not currently well-described."


"Technology-derived endpoints offer the benefit of capturing information about patients’ experience in ‘real-world’ settings," said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. "These tools have the potential to capture data that can be used to develop endpoints and evaluate therapies in the patient population."


Recommendations


CTTI offers three recommendations for optimizing novel endpoint selection and five recommendations on practical approaches to the novel endpoint development process.


In terms of optimization, CTTI recommends companies focus on measures that are meaningful to patients, select a suitable mobile device after selecting an outcome assessment and use a systematic approach to identify such novel endpoints as it can be a time-consuming and resource-intensive process.


CTTI also recommends "establishing industry-wide standards related to 1) terminology, 2) the collection and reporting of data captured by mobile devices, and 3) transparency requirements for the algorithms used to convert the data into physiologically and medically useful endpoints."

The partnership also encourages drug and medical device sponsors seeking to use a novel endpoint in a pivotal trial to interact with FDA during the Investigational New Drug (IND) application or Investigational Device Exemption (IDE) reviews.


"Notwithstanding the need for thoughtful selection and standards across measures, sponsors and academic investigators should add mobile technology-derived measures to existing studies and trials to determine which and how novel endpoints offer incremental utility over other assessments. CTTI recommends including novel endpoints as exploratory endpoints in existing studies in preference to solely conducting unique pilot studies," the recommendations say.




内容来自:Zachary Brennan

整理翻译:奥咨达



奥咨达翻译服务

奥咨达翻译团队根植于中国,面向全球,专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等,译稿已涵盖医疗器械领域的所有类型。


奥咨达翻译组联系方式:

邮箱:trans@osmundacn.com




(编辑:佚名 来源:本站原创)
分享按钮:
上一篇:【奥译言】FDA警告中国API制造商数据完整性问题
下一篇:医械采购8种行为将进黑名单

常用查询

    评审进度查询       |         医疗器械标准目录库       |         临床试验机构目录库       |         检测中心承检目录库

    医疗器械分类目录      |       医疗器械检测中心受检目录      |      国产必赢亚娱乐官网查询      |       进口必赢亚娱乐官网查询

更多>>

专家解读

奥咨达服务项目流程

临床试验
体外诊断试剂
进口注册
中国注册
质量管理体系
医械咨询
欧盟CE认证
美国FDA注册
海外注册
  • 经验丰富

    3000+医械客户,标准服务

  • 安全保障

    签订业务合同,资料专人管理

  • 合作无忧

    200+专业顾问,保质完成服务

  • 信誉卓著

    高新技术企业,信誉保障

  • 必赢亚娱乐官网|必赢亚娱乐官网

    XML 地图 | Sitemap 地图