Multiregional clinical trials for simultaneous global new drug development (2016) Pdf Free Download

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Global clinical development strategy utilizing multiregional clinical trials (MRCTs) plays a crucial role in developing innovative medicines. It is readily accepted that studying patients from many different regions within a single trial under a single protocol is an efficient method of trial design. The prevalence of these trials has been growing over the past few decades. MRCTs are most often conducted as a single trial focusing on the overall results, but when such trials are submitted to health authorities, the scope and concern often broaden to include the “local” results. Therefore, together with great opportunities, there are also tremendous challenges in the design, conduct, and interpretation of MRCTs.
This book is intended to provide a comprehensive view of the current status of conducting MRCTs in clinical development. It is a collection of chapters and sections contributed by different authors, each to address a different aspect of the important problems in global clinical development and MRCTs. The contributors to individual topics are from academia, industry, and health authorities around the globe. Section I provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. Sections II through IV are focused on the design, monitoring, and analysis/interpretation of MRCTs, respectively. The latest research topics in this area such as special considerations by local health authorities, health economic evaluations, benefit risks, and medical devices are provided in Section V.
The book is of particular interest to biostatisticians working in late-stage clinical development of medical products. It will also be helpful for statisticians and clinicians in the biopharmaceutical industry, regulatory agencies, and medical research institutes.



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