Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and moreExtensively covers the study schema and related features of study designIncorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trialsIncludes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers INDICE: Introduction The Origins of DrugsIntroduction to Clinical Trial DesignRun-in PeriodInclusion/Exclusion Criteria, Stratification and Subgroups - Part IInclusion and Stratification Criteria - Part IIRandomization, Allocation, and BindingIntent to Treat Analysis vs. Per Protocol AnalysisBiostatistics - Part IBiostatistics - Part IIIntroduction to Endpoints for Clinical Trials in PharmacologyEndpoints in Clinical Trials on Solid Tumors - Objective ResponseOncology Endpoints: Overall Survival and Profession-Free SurvivalOncology Endpoints:  Time to ProgressionOncology Endpoint: Disease-Free SurvivalOncology Endpoint: Time to Distant MetastasisNeoadjuvant Therapy vs. Adjuvant TherapyHematological CancersBiomarkers and Personalized MedicineEndpoints in Immune DiseasesEndpoints in Clinical Trials on InfectionsHealth-Related Quality of LifeHealth-Related Quality of Life Instruments for Immune DisordersHealth-Related Quality of Life Instruments and InfectionsDrug SafetyMechanisms of Action, Part IMechanisms of Action, Part II - CancerMechanisms of Action, Part III - Immune Disorders Mechanisms of Action, Part IV- InfectionsConsent FormsPackage InsertsRegulatory ApprovalPatents

• ISBN: 978-0-12-804217-5
• Editorial: Academic Press
• Encuadernacion: Cartoné
• Páginas: 688
• Fecha Publicación: 14/03/2016
• Nº Volúmenes: 1
• Idioma: Inglés