02873nam a2200289Ia 4500008004100000020001800041050002300059099001000082100001500092245011800107250002000225264006500245300005500310500005100365505125100416520072601667521000802393590001302401591001702414650002902431650003002460650001902490650002002509650002102529942001602550999001702566230719s2016    xx            000 0 und d  a9780128042175  aR 853.C55 B76 2016  a15835  aBrody, Tom10aClinical trials : bstudy design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines/cBrody, Tom.  aSecond edition.  aAmsterdam, Netherlands :bbElsevier/Academic Press, c2016.  axxxii, 863 pages : bsome illustrations ; c24 cm.  aIncludes bibliographical references and index.  aOrigins of drugs -- Clinical trial design -- Run-in period -- Inclusion/exclusion criteria, stratification, and subgroups, part I -- Inclusion/exclusion criteria, stratification, and subgroups, part II -- Blinding, randomization, and allocation -- Placebo arm as part of clinical trial design -- Intent-to-treat analysis versus per protocol analysis -- Biostatistics, part I -- Biostatistics, part II -- Introduction to endpoints -- Oncology endpoints : overall survival and progression-free survival -- Oncology endpoints : time to progression -- Oncology endpoint : disease-free survival -- Oncology endpoint : time to distant metastasis -- Neoadjuvant therapy versus adjuvant therapy -- Hematological cancers -- Biomarkers -- Endpoints for immune diseases -- Endpoints for infections -- Health-related quality of life tools --oncology -- Health-related quality-of-life tools --immune disorders -- Health-related quality-of-life tools --infections -- Drug safety -- Mechanism of action of diseases and drugs, part I -- Mechanism of action, part II (cancer) -- Mechanism of action, part III (immune disorders) -- Mechanisms of action, part IV (infections) -- Consent forms -- Package inserts -- Warning letters -- Regulatory approval -- Patents.  aThis text 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.  aMED  aMEDICINE  a/Brody, Tom.  aClinical trialsxDesign.  aClinical trials as topic.  aDrug approval.  aDrugsxTesting.  aResearch design.  2lcchRcMED  c87258d87258