Clinical Trials with Quality of Life Outcomes

The use of quality-of-life (QoL) measures as important outcome variables in randomized clinical trials (RCTs) is increasing. In this Workshop we discuss some of the reasons for this increase - practical, theoretical, regulatory, and ethical - and we review some of the prerequisites thought necessary for the successful conduct of such trials. We consider how QoL may be defined and how definition(s) have implication(s) for its measurement. We then review the basic structure of the RCT and consider situations in which the use of QoL outcomes are indicated. Included in this are measures that combine length of life with quality. Finally, we look at a series of examples of RCTs with QoL outcomes and describe some of the problems encountered along the way. Suggestions for amelioration are proffered.

Instructor:

Chuck Kowalski is a Faculty Associate at CSCAR and Professor in the School of Dentistry at the University of Michigan. He joined the U-M in 1968, and has considerable statistical consulting experience in biomedical contexts, including work with pharmaceutical companies, the National Football League, the Nijmegen Growth Study, the Lancaster Cleft Palate Clinic, and the Frei University in Amsterdam. He served as Chair of the Health Sciences Institutional Review Board from 1997-2003. He is currently Co-chair of that committee, and has interests in research ethics, especially with respect to study design and risk/benefit analysis. He continues his work with the U-M PEERRS web-based system for education in the responsible conduct of research.

Audience:

Anyone interested in QoL measurement or the use of QoL measures in evaluating/comparing health-care interventions.

Prerequisite:

Familiarity with basic statistical concepts and procedures, say at the level of CSCAR's Workshop, "Statistics: A Review." Knowledge of the basics of measuring health (QoL) and the structure of RCTs, as covered in CSCAR's Workshops, "Health Measurement," and "Randomized Controlled Trials" would be helpful, but not necessary.

Provisions:

The enrollee will receive lecture notes, a bibliography. Morning and afternoon refreshments provided. Break time for lunch (lunch not provided).

When:

Friday, March 30, 2007, 8:30 a.m. - 5:00 p.m.

Location:

Fee:

Registration until March 16, 2007:

$150 for University of Michigan affiliated faculty, staff and students; 

$325 for others

Registration after March 16, 2007:

$180 for University of Michigan affiliated faculty, staff and students; 

$390 for others.

Registration:

Call CSCAR at 734-764-7828. Enrollment is limited. Please make check payable to CSCAR-University of Michigan, or give the University of Michigan Project/Grant or short code to be billed. Send check to CSCAR, 3550 Rackham Bldg., University of Michigan, 915 E. Washington St., Ann Arbor MI 48109-1070.