000			04155cam a2200493Ki 4500
001			ocn945375877
003			OCoLC
005			20190328114814.0
006			m o d
007			cr cnu---unuuu
008			160322s2016 enk ob 001 0 eng d
040			_aOPELS _beng _erda _epn _cOPELS _dUIU _dOCLCF _dGGVRL _dTMC _dOCLCO _dUIU _dMERER _dOCLCO _dOCLCQ _dLEATE _dU3W _dOCLCA _dBUF _dOCLCO _dD6H _dUUM _dAU@ _dOCLCQ
019			_a951033138 _a956735896
020			_a9780128042588
020			_a0128042583
020			_z9780128042175
020			_z0128042176
035			_a(OCoLC)945375877 _z(OCoLC)951033138 _z(OCoLC)956735896
050		4	_aR853.C55
060		4	_aQV 771.4 _bB864c
082	0	4	_a615.50724 _223
100	1		_aBrody, Tom, _eauthor.
245	1	0	_aClinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines / _h[electronic resource] _cTom Brody, Ph. D.
250			_a2nd ed.
264		1	_aLondon : _bAcademic Press is an imprint of Elsevier, _c2016.
300			_a1 online resource
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
520			_aClinical 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.
500			_aIncludes index.
588	0		_aOnline resource; title from PDF title page (ScienceDirect, viewed March 22, 2016).
504			_aIncludes bibliographical references and index.
505	0		_a1. Origins of drugs -- 2. Clinical trial design -- 3. Run-in period -- 4. Inclusion/exclusion criteria, stratification, and subgroups -- part I -- 5. Inclusion/exclusion criteria, stratification, and subgroups -- part II -- 6. Blinding, randomization, and allocation -- 7. Placebo arm as part of clinical trial design -- 8. Intent-to-treat analysis versus per protocol analysis -- 9. Biostatistics -- part I -- 10. Biostatistics -- part II -- 11. Introduction to endpoints -- 12. Oncology endpoint -- objective response -- 13. Oncology endpoints : overall survival and progression-free survival -- 14. Oncology endpoints : time to progression -- 15. Oncology endpoint : disease-free survival -- 16. Oncology endpoint : time to distant metastasis -- 17. Neoadjuvant therapy versus adjuvant therapy -- 18. Hematological cancers -- 19. Biomarkers -- 20. Endpoints for immune diseases -- 21. Endpoints for infections -- 22. Health-related quality of life tools -- oncology -- 23. Health-related quality-of-life tools -- immune disorders -- 24. Health-related quality-of-life tools -- infections -- 25. Drug safety -- 26. Mechanism of action of diseases and drugs -- part I -- 27. Mechanism of action -- part II (cancer) -- 28. Mechanism of action -- part III (immune disorders) -- 29. Mechanisms of action -- part IV (infections) -- 30. Consent forms -- 31. Package inserts -- 32. Warning letters -- 33. Regulatory approval -- 34. Patents.
650		0	_aClinical trials _xDesign.
650		7	_aClinical trials _xDesign. _2fast _0(OCoLC)fst00864431
650	2	2	_aClinical Trials as Topic.
650	2	2	_aDrug Approval.
650	2	2	_aResearch Design.
650	2	2	_aClinical Trials Data Monitoring Committees.
655		4	_aElectronic books.
776	0	8	_iPrint version: _aBrody, Tom. _tClinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. _dSaint Louis : Elsevier Science, �2016 _z9780128042175
856	4	0	_3ScienceDirect _uhttp://www.sciencedirect.com/science/book/9780128042175
999			_c247305 _d247305