图书简介
This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.
Preface.- Part I. Real-World Data and Evidence to Accelerate Medical Product Development.- The need for real world data/evidence in clinical development and life cycle management, and future directions.- Overview of current RWE/RWD landscape.- Key considerations in forming research questions.- Part II. Fit-for-use RWD Assessment and Data Standards.- Assessment of fit-for-use real-world data sources and applications.- Key variables ascertainment and validation in real-world setting.- Data standards and platform interoperability.- Privacy-preserving data linkage for real-world datasets.- Part III. Causal Inference Framework and Methodologies in RWE Research.- Causal Inference with Targeted Learning for Producing and Evaluating Real-World Evidence.- Framework and Examples of Estimands in Real-World Studies.- Clinical Studies Leveraging Real-World Data Using Propensity Score-Based Methods.- Recent statistical development for comparative effectiveness research beyond propensity-score methods.- Innovative Hybrid Designs and Analytical Approaches leveraging Real-Word Data and Clinical Trial data.- Statistical challenges for causal inference using time-to-event real-world data.- Sensitivity Analyses for Unmeasured Confounding: This is the way.- Sensitivity analysis in the analysis of real-world data.- Personalized medicine with advanced analytics.- Use of Real-World Evidence in Health Technology Assessment Submissions.- Part IV. Application and Case studies.- Examples of applying causal-inference roadmap to real-world studies.- Applications using real-world evidence to accelerate medical product development.- The use of real-world data to support the assessment of the benefit and risk of a medicine to treat spinal muscular atrophy.- Index.
Trade Policy 买家须知
- 关于产品:
- ● 正版保障:本网站隶属于中国国际图书贸易集团公司,确保所有图书都是100%正版。
- ● 环保纸张:进口图书大多使用的都是环保轻型张,颜色偏黄,重量比较轻。
- ● 毛边版:即书翻页的地方,故意做成了参差不齐的样子,一般为精装版,更具收藏价值。
关于退换货:
- 由于预订产品的特殊性,采购订单正式发订后,买方不得无故取消全部或部分产品的订购。
- 由于进口图书的特殊性,发生以下情况的,请直接拒收货物,由快递返回:
- ● 外包装破损/发错货/少发货/图书外观破损/图书配件不全(例如:光盘等)
并请在工作日通过电话400-008-1110联系我们。
- 签收后,如发生以下情况,请在签收后的5个工作日内联系客服办理退换货:
- ● 缺页/错页/错印/脱线
关于发货时间:
- 一般情况下:
- ●【现货】 下单后48小时内由北京(库房)发出快递。
- ●【预订】【预售】下单后国外发货,到货时间预计5-8周左右,店铺默认中通快递,如需顺丰快递邮费到付。
- ● 需要开具发票的客户,发货时间可能在上述基础上再延后1-2个工作日(紧急发票需求,请联系010-68433105/3213);
- ● 如遇其他特殊原因,对发货时间有影响的,我们会第一时间在网站公告,敬请留意。
关于到货时间:
- 由于进口图书入境入库后,都是委托第三方快递发货,所以我们只能保证在规定时间内发出,但无法为您保证确切的到货时间。
- ● 主要城市一般2-4天
- ● 偏远地区一般4-7天
关于接听咨询电话的时间:
- 010-68433105/3213正常接听咨询电话的时间为:周一至周五上午8:30~下午5:00,周六、日及法定节假日休息,将无法接听来电,敬请谅解。
- 其它时间您也可以通过邮件联系我们:customer@readgo.cn,工作日会优先处理。
关于快递:
- ● 已付款订单:主要由中通、宅急送负责派送,订单进度查询请拨打010-68433105/3213。
本书暂无推荐
本书暂无推荐