Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines / [electronic resource] Tom Brody, Ph. D. Brody, Tom, author. Clinical trials Design. Clinical Trials as Topic. Drug Approval. Research Design. Clinical Trials Data Monitoring Committees. R853.C55 615.50724 23 Includes index. Includes bibliographical references and index. Online resource; title from PDF title page (ScienceDirect, viewed March 22, 2016). 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. 2016 Text 1 online resource http://www.sciencedirect.com/science/book/9780128042175 eng Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines.