JSM 2004 - Toronto

Abstract #302270

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Activity Number: 148
Type: Topic Contributed
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #302270
Title: Quality of Life Endpoints in Clinical Trials: From Start to Finish
Author(s): Amylou Dueck*+ and Sumithra J. Mandrekar and Paul Novotny and Pamela Atherton and Jeff A. Sloan
Companies: Mayo Clinic Cancer Center and Mayo Clinic and Mayo Clinic Cancer Center and Mayo Clinic Cancer Center and Mayo Clinic Cancer Center
Address: 3725 N. Peseo Del Sol, Mesa, AZ, 85207-1857,
Keywords:
Abstract:

Quality of life (QOL) represents any outcome related to patient well-being, health, performance status, or symptom distress. Statisticians are often at the crossroads caught between investigators wanting to measure patient QOL and regulatory agencies looking for a sound scientific rationale for its inclusion, the proposed analysis plans and interpretation of results. The purpose of this paper is to provide a walking tour of the implementation of QOL endpoints in clinical trials from a statistician's perspective. The challenges faced by statisticians at the design (endpoints, choosing appropriate QOL tools, power calculations based on clinical significance, etc.) and analysis stage (choosing appropriate graphical and statistical procedures, methods to handle missing data, etc.) will be discussed. General guidelines to systematically address some of these issues will be proposed. With the help of examples, we show that the design and analysis of a QOL endpoint in a clinical trial is not necessarily different from other well-known and accepted endpoints like tumor response and survival. Clinical trial examples are drawn from oncology treatment and cancer control studies carried out by the North Central Cancer Treatment Group (NCCTG) and Mayo Clinic. We provide macro code to carry out the analyses undertaken.

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Revised March 2004