000			02876nam a2200289Ia 4500
008			230719s2016 xx 000 0 und d
020			_a9780128042175
050			_aR 853.C55 B76 2016
099			_a15835
100			_aBrody, Tom
245	1	0	_aClinical trials : _bstudy design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines/ _cBrody, Tom.
250			_aSecond edition.
264			_aAmsterdam, Netherlands : _b _bElsevier/Academic Press, _c2016.
300			_axxxii, 863 pages : _bsome illustrations ; _c24 cm.
500			_aIncludes bibliographical references and index.
505			_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.
520			_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.
521			_aMED
590			_aMEDICINE
591			_a/Brody, Tom.
650			_aClinical trials _xDesign.
650			_aClinical trials as topic.
650			_aDrug approval.
650			_aDrugs _xTesting.
650			_aResearch design.
942			_2lcc _hR _cMED
999			_c87258 _d87258