American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
Biostatistics Seminar Series


Andrea Troxel, Ph.D.
Professor, Department of Population Health
NYU Langone Health

PRAGMATIC CLINICAL TRIALS AND NEW APPROACHES TO CONSENT

Pragmatic clinical trials aim to enroll a sample of participants that is widely representative of the target population, in order to enhance generalizability. To accomplish this goal, eligibility criteria are made less restrictive than in explanatory trials. Some critical but often overlooked drivers of selection, however, are the enrollment and consent processes themselves; standard "opt-in" consent processes, in particular, tend to result in a non-representative, more engaged sample of trial participants. An alternative is the use of "opt-out" framing when recruiting trial participants. We explore the ethical, practical, and technical aspects of such an approach, with particular attention to its impact on statistical power and effect size. We use the framework of a latent variable that is associated with both the propensity to enroll and the responsiveness to treatment, and simulate a wide array of possible scenarios. We provide examples relating to behavioral interventions in chronic disease.


Date: Wednesday, February 7, 2018
Time: 4:00 - 5:00 P.M.
Location: Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
485 Lexington Avenue
(Between 46th & 47th Streets)
2nd Floor, Conference Room B
New York, New York

**Outside visitors please email celeat@mskcc.org for building access. You must be on the security list to enter the floor.

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