Abstract
| DATE: | January 24, 2013 |
| TIME: | 1:15 - 3:00 pm |
| LOCATION: | Medical School Office Building, Rm x303 |
| TITLE: | Sequential Methods for Comparative Effectiveness Experiments: Point of Care Clinical Trials |
| SPEAKER: | Mei-Chiung Shih, Assistant Professor VA Palo Alto Cooperative Studies Program Coordinating Center Department of Health Research and Policy, Stanford |
The goal of comparative effectiveness research (CER) is to support evidence-based choices of
treatments already in use. Currently the majority of randomized clinical trials for CER are conducted
in the traditional research mode which requires designated study personnel and data collection and
management systems. They are also usually designed to demonstrate superiority, and often require large
sample sizes, because there can be more than two treatments to be compared and the effect sizes between
treatments in current use are typically small to moderate. Such traditional trials can therefore be very
expensive. In this talk, we describe two novel clinical trial design features for such CER:
(1) Point-of-care clinical trials, which aim to embed clinical research in routine care and can
integrate experiment and implementation; (2) selection instead of superiority; aiming to select treatments
whose results are close to the best treatment, by eliminating (at interim analyses) non-promising treatments
that are unlikely to be much better than the currently observed best treatment based on generalized
likelihood ratio tests. These approaches can also be used for implementation of new care guidelines or
new but approved interventions/devices.
This is joint work with Professor Philip Lavori.
Suggested reading:
Fiore et al. A point-of-care clinical
trial comparing insulin administered using a sliding scale versus a weight-based regimen.
Clinical Trials 2011; 8:183-195.
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