Customer Reviews

Clinical Trials: A Methodologic Perspective

5 star:		(4)
4 star:		(1)
3 star:		(0)
2 star:		(0)
1 star:		(0)

 

 

This book is very unique. Basic statistical concepts are clearly presented but only those concepts that are important in clinical trials. The author presents all the issues with clinical trials including ethical issues with some historical perspective. Principles of randomization and statistical design are clearly presented. It offers discussion of Bayesian techniques and meta-analyses, cross-over designs and group sequential methods (interim analyses). For statisticians doing clinical research like myself, this is a valuable reference source.

The amount of knowledge and the scope of this book are the exact need for the first contact with clinical trials. Yet, it is not a simple or superficial text. Instead, it not only will guide the reader through the basics of trials (and there is so much that is not basic in it) but the author points the reader to hundreds of papers and books that are landmarks. I regard this book itself as one of these landmarks!

Covers many aspects of trials (particularly facets of design and analysis)not yet covered by other books, eg randomisation with minimisation, and meta-analysis of trial results. Readable, applicable, practical, good references, well structured.

It is a very good course book for graduates in clinical trial design and practice. It is also a great reference for biostatisticians and clinical investigators who have solid knowledge background in biostatistics and mathematics. However, it may be a challenge to understand the detailed statistic and math equations and theories by those clinical scientists in pharmacology, toxicology, PKDM, and even clinical data programmers and project managers in pharmaceutical industry. Since clinical trials in pharmaceutical industry are carried out following FDA and ICH guidelines, those clinical scientists and project managers may expect more practical procedures in clinical trial design and examples of data analyses and statistical decisions for new drugs or decease treatments, which demonstrate how to design and judge clinical trials under FDA and ICH guidelines.

This is an excellent book. It outlines the important issues of clinical trials well. It is understandable and thorough. A must for anyone who is interested in actually doing trials. Not a good book for a brief, superficial overview.