Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
- Tom Brody, PhD, University of California at Berkeley, The author is a former employee of Schering-Plough Corporation. He has ten years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Athena Neurosciences (Elan Pharmaceuticals), and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C.
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.
Pharmaceutical scientists and pharmacologists, medical writers and physicians, nurses and pharmacists who plan and conduct clinical trials.