CAPS Methods Core Seminar: Steven Gregorich, PhD

Controversies and Unresolved Issues in the Design of Randomized Controlled Trials Testing Clinical/Behavioral Interventions

550 16th St
San Francisco, CA 94158
United States

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Within the context of an efficacy, effectiveness, or implementation science trial (RCT), many clinical/behavioral trialists insist that optimal study designs require (i) intervention and control groups that are matched with respect to the amount of time and attention required of study participants and (ii) adjustments to alpha levels for 'multiple comparisons.'  Other clinical/behavioral trialists argue that (i) a 'usual care' control group design often is best and (ii) adjustments for 'multiple comparisons' are unnecessary and undesirable.  In this talk, I detail scientific, policy-related, and ethical arguments for the superiority of the latter perspective.  Additionally, some scientists contend that pilot trials, in part, are intended to yield an effect size estimate that will inform a power analysis supporting the design of a future full-scale RCT, whereas others argue that pilot trials should limit their focus to evaluating acceptability and feasibility of the intervention and study procedures.  The latter viewpoint is the correct one, but raises a question about how to determine the appropriate effect size estimate to use in a power analysis.  We will discuss related issues including implications for obtaining research funding and publishing results from RCTs.


Steve's research focuses on disease prevention and preventive health behaviors within diverse populations. His 24-year career includes over 75, largely federally funded, research projects, centers, and career development awards.  Relevant to this talk, he has served as principal statistician and/or data coordinating center director of 20 large-scale randomized controlled trials testing behavioral/clinical interventions.

Title:  Controversies and Unresolved Issues in the Design of Randomized Controlled Trials Testing Clinical/Behavioral Interventions

Presenter: Steve Gregorich, PhD

Department of Medicine & Department of Preventive and Restorative Dental Sciences, UCSF

Date and Time: Tuesday, October 23, 2018, 11:00 am– 1:00 pm

Location: AmFAR Conference room, MH-3700 , 550 16th Street (at 4th Street), 3rd Floor, Mission Bay, SF 94158

Please RSVP to Estie Hudes; also let her know if you are coming from outside Mission Hall and need to be put on the building security list.