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Monitoring Clinical Trials
Statistical, philosophical, and ethical issues
March 17, 2006
Chuck Kowalski
It is not uncommon for investigators to analyze clinical trial data several times as they accumulate during the planned course of the study. Thus, e.g., in a trial planned to last for a period of five years, groups may be compared annually or, even, every six months. This is done first for safety, to ensure that the participants in the trial are not being harmed by the intervention, but also to enable the early stopping of trials when efficacy is clearly established; or in case it is unlikely that efficacy will be established when all the data are in. These ethical safeguards require that adjustments to analysis strategies be made to account for the fact that multiple testing affects the overall significance level of the tests. For example, if five tests are done, each at the nominal 5% level of significance, the probability that one or more will be significant even when the groups do not differ is over 20%.
In this Workshop we elaborate on the philosophical and ethical dimensions of study monitoring, and present some of the statistical methods that have been developed to control inflation of the type I error rate associated with multiple testing. Particular attention is paid to clinical equipoise as the ethical anchor of clinical trials and the use of Data and Safety Monitoring Boards as exclusive, apartheid keepers of the accumulating data.
- Instructors
- 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 monitoring clinical trials.
- Prerequisite
- Familiarity with basic statistical concepts and procedures, say at the level of CSCAR's Workshop, Statistics: A Review. Knowledge of the basic structure of RCTs, as covered in CSCAR's Workshop, 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).
- Dates & Times
- March 17, 2006, 8:30 AM - 5:00 PM
- Location
- Rackham Building, West Conference Room, 4th Floor.
- Fees
- $150 for University of Michigan affiliated faculty, staff and students
- $325 for others
Registrations on or before March 6, 2006 - $180 for University of Michigan affiliated faculty, staff and students
- $390 for others
Registrations after March 6, 2006 Please make check payable to CSCAR-University of Michigan, or give the University of Michigan Project/Grant or shortcode to be billed. Send check to CSCAR, 3550 Rackham Bldg., University of Michigan, 915 E. Washington St., Ann Arbor, MI, 48109-1070.
- Registration
- Call CSCAR at 734-764-7828. Enrollment is limited.