Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /

Saved in:
Bibliographic Details
Author / Creator:Brody, Tom, author.
Edition:Second edition.
Imprint:London : Academic Press is an imprint of Elsevier, 2016.
Description:1 online resource
Language:English
Subject:Clinical trials -- Design.
Clinical trials -- Design.
Clinical Trials as Topic.
Drug Approval.
Research Design.
Clinical Trials Data Monitoring Committees.
Electronic books.
Format: E-Resource Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/11253892
Hidden Bibliographic Details
ISBN:9780128042175
0128042176
Notes:Includes index.
Includes bibliographical references and index.
Online resource; title from PDF title page (ScienceDirect, viewed March 22, 2016).
Summary: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.
LEADER 04330cam a2200469Ki 4500
001 11253892
005 20180526095827.7
006 m o d
007 cr cnu---unuuu
008 160322s2016 enk ob 001 0 eng d
019 |a 956735896 
020 |z 9780128042175 
020 |z 0128042176 
035 |a (OCoLC)945375877  |z (OCoLC)956735896 
040 |a OPELS  |b eng  |e rda  |e pn  |c OPELS  |d UIU  |d OCLCF  |d GGVRL  |d TMC  |d OCLCO  |d UIU  |d MERER  |d OCLCO  |d OCLCQ  |d LEATE  |d U3W  |d OCLCA  |d BUF  |d OCLCO 
049 |a MAIN 
050 4 |a R853.C55 
060 4 |a QV 771.4  |b B864c 
100 1 |a Brody, Tom,  |e author.  |0 http://id.loc.gov/authorities/names/n92025750 
245 1 0 |a Clinical trials :  |b study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /  |c Tom Brody, Ph. D. 
250 |a Second edition. 
264 1 |a London :  |b Academic Press is an imprint of Elsevier,  |c 2016. 
300 |a 1 online resource 
336 |a text  |b txt  |2 rdacontent  |0 http://id.loc.gov/vocabulary/contentTypes/txt 
337 |a computer  |b c  |2 rdamedia  |0 http://id.loc.gov/vocabulary/mediaTypes/c 
338 |a online resource  |b cr  |2 rdacarrier  |0 http://id.loc.gov/vocabulary/carriers/cr 
520 |a 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. 
500 |a Includes index. 
588 0 |a Online resource; title from PDF title page (ScienceDirect, viewed March 22, 2016). 
504 |a Includes bibliographical references and index. 
505 0 |a 1. 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 |a Clinical trials  |x Design. 
650 7 |a Clinical trials  |x Design.  |2 fast  |0 http://id.worldcat.org/fast/fst00864431 
650 2 2 |a Clinical Trials as Topic.  |0 http://id.nlm.nih.gov/mesh/D002986 
650 2 2 |a Drug Approval.  |0 http://id.nlm.nih.gov/mesh/D017277 
650 2 2 |a Research Design.  |0 http://id.nlm.nih.gov/mesh/D012107 
650 2 2 |a Clinical Trials Data Monitoring Committees.  |0 http://id.nlm.nih.gov/mesh/D026661 
655 4 |a Electronic books. 
903 |a HeVa 
929 |a oclccm 
999 f f |i d8232eca-aaef-50f6-a1da-f3f83787b755  |s 28ff539e-7687-5aee-b24b-b7cdd9798fc4 
928 |t Library of Congress classification  |a R853.C55  |l Online  |c UC-FullText  |u https://www.sciencedirect.com/science/book/9780128042175  |z Elsevier  |g ebooks  |i 10978878