Design and Analysis of Quality of Life Studies in Clinical Trials

Rating:
Summary: qol and missing data for statisticians
Review: This is really the first really good book for statisticians on quality of life issues and methods with authoritative references. The author provides practical advice for qol studies in a clinical trials setting and provides sage advice on design of the study. Actual quality of life surveys are discussed and the importance of defining objectives is emphasized. Some real cancer trials are discussed and used as examples throughout the book. There is detailed treatment of missing data and how to deal with it including the latest statistical methodology. Much of the methodological development could apply to hard endpoints as well as qol endpoints.
I got this book and a good taste of its contents in a short course presented by the author at the Joint Statistical meetings in New York in August 2002. The only drawback of the book is that it does not spend much time on the issue of instrument validation. Also the author's experience is with cancer trials in an academic setting. The issues related to conducting qol surveys for a manufacturer that needs labeling or FDA approval efficacy and safety approvals is a prospective that I would like to see but the author does not have.
Excellent examples illustrated in SAS and SPlus.

Rating:
Summary: qol and missing data for statisticians
Review: This is really the first really good book for statisticians on quality of life issues and methods with authoritative references. The author provides practical advice for qol studies in a clinical trials setting and provides sage advice on design of the study. Actual quality of life surveys are discussed and the importance of defining objectives is emphasized. Some real cancer trials are discussed and used as examples throughout the book. There is detailed treatment of missing data and how to deal with it including the latest statistical methodology. Much of the methodological development could apply to hard endpoints as well as qol endpoints.
I got this book and a good taste of its contents in a short course presented by the author at the Joint Statistical meetings in New York in August 2002. The only drawback of the book is that it does not spend much time on the issue of instrument validation. Also the author's experience is with cancer trials in an academic setting. The issues related to conducting qol surveys for a manufacturer that needs labeling or FDA approval efficacy and safety approvals is a prospective that I would like to see but the author does not have.
Excellent examples illustrated in SAS and SPlus.