“Dr. Speid, taking advantage of her own professional experiences, provides an easy to follow and understandable guide to clinical trials. She describes how human clinical trials are developed, the ethics involved in these trials, including a discussion of risk-benefit ratios, and how the physician at times serves dual roles as caregiver and study investigator. She has chapters on certain ‘vulnerable populations’ such as the elderly, children, and patients with rare or orphan diseases. With the need for increased, truly informed subjects in clinical trials, this book provides a rich resource for those contemplating participation in such trials.”
David A. Williams, MD, Chief of the Division of Hematology/Oncology, Director of Translational Research for Children’s Hospital Boston, and Leland Fikes Professor of Pediatrics, Harvard Medical School
“In clinical research, the patient’s full understanding of the informed consent procedure is paramount. However, for the patient, coming to the research site without the prior knowledge of the clinical trial information, it can be a challenging and time-consuming process for both patient and investigator. This very well-written and easy-to-read handbook is an excellent solution to this problem. As a Principal Investigator, I have been searching for this type of written information for a long time. It is a must-have resource for every clinical trial subject and investigator.”
Gioi N. Smith-Nguyen, MD, FACOG, Grossmont Center for Clinical Research, La Mesa, California
“Dr. Speid provides an excellent summary of the increasingly complex world of clinical trials. The clinical vignettes bring otherwise murky issues into sharp focus. The ‘questions to ask’ sections make this book indispensible for those considering enrolling themselves or their loved ones into clinical trials, providing a framework within which to make fully informed decisions.
This is a must-read for those wanting a better understanding of the pros and cons of participating in modern-day drug development.”
David A. Merrill, MD, PhD, Investigator, Division of Geriatric Psychiatry, Memory & Aging Research Center, Semel Institute for Neuroscience & Human Behavior, David Geffen School of Medicine at University of California, Los Angeles