04155cam a2200493Ki 4500 ocn945375877 OCoLC 20190328114814.0 m o d cr cnu---unuuu 160322s2016 enk ob 001 0 eng d OPELS eng rda pn OPELS UIU OCLCF GGVRL TMC OCLCO UIU MERER OCLCO OCLCQ LEATE U3W OCLCA BUF OCLCO D6H UUM AU@ OCLCQ 951033138 956735896 9780128042588 0128042583 9780128042175 0128042176 (OCoLC)945375877 (OCoLC)951033138 (OCoLC)956735896 R853.C55 QV 771.4 B864c 615.50724 23 Brody, Tom, author. Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines / [electronic resource] Tom Brody, Ph. D. 2nd ed. London : Academic Press is an imprint of Elsevier, 2016. 1 online resource text txt rdacontent computer c rdamedia online resource cr rdacarrier 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. Includes index. Online resource; title from PDF title page (ScienceDirect, viewed March 22, 2016). Includes bibliographical references and index. 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. Clinical trials Design. Clinical trials Design. fast (OCoLC)fst00864431 Clinical Trials as Topic. Drug Approval. Research Design. Clinical Trials Data Monitoring Committees. Electronic books. Print version: Brody, Tom. Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Saint Louis : Elsevier Science, �2016 9780128042175 ScienceDirect http://www.sciencedirect.com/science/book/9780128042175 247305 247305