Fundamentals of Clinical Trials

by Lawrence M. Friedman

Introduction to Clinical Trials.- Ethical Issues.- What is the Question?.- Study Population.- Basic Study Design.- The Randomization Process.- Blinding.- Sample Size.- Baseline Assessment.- Recruitment of Study Participants.- Data Collection and Quality Control.- Assessment and Reporting of Harm.- Assessment of Health Related Quality of Life.- Participant Adherence.- Survival Analysis.- Monitoring Committee Structure & Function.- Statistical Methods Used in Interim Monitoring.- Issues in Data Analysis.- Closeout.- Reporting and Interpreting of Results.- Multicenter Trials.- Regulatory Issues.

Genres: Textbooks, Medicine, Health Care, Psychology, Reference

574 pages, Paperback

First published November 30, 1981

About the author

Professor of law.

Also author of mystery novels, The Frank May Chronicles.

Reviews

[Scott Pearson · Rating 5 out of 5]

In the past century, clinical research has grown dramatically as the number of questions about healthcare has increased. The current paradigm of evidence-based medicine describes the practice of prescribing medicines based on their tested strength instead of an individual’s limited experience. Of course, to make such judgments, a rich bed of research evidence needs to exist, and this book succinctly describes how such questions are investigated for eventual dissemination.

This book’s language is succinct and clearly intended for time-strapped researchers & physicians. It does not expand on or illustrate many of the concepts but presumes a high level of clinical knowledge among its readers. The audiobook version, which I listened to, is also abridged and does not contain contents of the full edition.

That said, it offers a comprehensive introduction to the topic. Indeed, I wonder whether re-listening to it might provide me with some benefits because I’m sure I missed a lot in its dense presentation. Even considered are newer topics like research designs besides a randomized clinical trial (the gold standard). The audiobook format provides a proper way to listen to-and-from work or during meal breaks.

[Mary Jean · Rating 4 out of 5]

Good first book on understanding clinical trial vocabulary, background, planning, and regulatory requirements. Will keep as reference.

[Monika]

PQHS 450

[Mike · Rating 4 out of 5]

A must-have for anyone just starting out in clinical trials. Clearly written and full of references for further exploration.

[Zhifei Ge · Rating 4 out of 5]

A well structured introduction to clinical trials. Something to improve is better examples of explaining key concepts.