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Activity Number:
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301
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 14, 2002 : 10:30 AM to 12:20 PM
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Sponsor:
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ENAR
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| Abstract - #301279 |
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Title:
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A Method of Incorporating Subject and Clinician Preferences in Random Treatment Allocation
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Author(s):
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Stephen Wisniewski*+ and Philip Lavori
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Affiliation(s):
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University of Pittsburgh and Stanford University
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Address:
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127 Parran Hall/130 DeSoto Street, Pittsburgh, Pennsylvania, 15261, USA
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Keywords:
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clinical trial ; randomization ; equipoise
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Abstract:
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Many efficacy studies have identified a variety of drugs that are effective in the treatment of psychiatric disorders. Recently large-scale studies have been initiated to assess the effectiveness of standard treatments for bipolar disorder and treatment resistant depression. Subjects with these disorders often have strong opinions on what treatments are acceptable, which has implications on identifying those that would be willing to consent to participate in the study and subsequently the generalizability of the results of the trial. In order to address this shortcoming, the equipoise-stratified randomization approach was developed and implemented in studies of bipolar disorder and treatment-resistant depression. The equipoise-stratified randomization approach permits those involved in the trial to eliminate treatment options, as long as the remaining treatment options permit the possibility of randomization. We will present a summary of the equipoise-stratified randomization approach and review some of the analytic strategies that can be implemented in the analyses of studies that use this approach, including model bases analyses and the use of permutation tests.
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