To Adjust or Not to Adjust?: Simple vs. Adaptive/Forced Randomization

• Activity Number: 198
• Type: Roundtables
• Date/Time: Monday, August 2, 2010 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Yuko Y. Palesch*+
• Companies: Medical University of South Carolina
• Keywords: adaptive randomization ; forced randomization

Abstract

In multicenter randomized clinical trials (RCTs), a variety of randomization strategies exist to control for treatment group balance while attempting to maintain the randomness of treatment allocation to protect the validity of statistical inferences. Recently, with improved interactive technologies, dynamic (i.e., treatment-, covariate-, and response-adaptive) and forced randomization methods have appeared frequently in the literature and have become popular in multicenter RCTs. These adjustments to simple randomization pose a challenge to implement (unlike the statically adjusted randomization), and statistically, they remain controversial. The roundtable discussion will debate the pros and cons of adjustments to simple randomization in a multicenter setting where randomization is managed centrally.