Health Research and Policy

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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