The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees) in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences. One key operational management issue when producing analysis for DMCs is that rules must be defined so that trial unblinding is not compromised and bias remains controlled. In this blog, we will explore an innovative approach developed by members of our statistical programming team to improve the efficiency of this process, while maintaining the highest levels of data security.
During last week’s East Users Group Meeting, Michael Proschan of the NIH and NIAID, gave a presentation on ‘Blinded Adaptations, Permutations and t-tests.’ Given the close connection between adaptive t-tests and adaptive permutation tests, Proschan argued that it is possible to determine the validity of an adaptive t-test from the validity of an adaptive permutation test. Proschan concludes that in adaptive settings, “permutation tests are often valid in adaptive settings, even if blind is maintained.”
Michael's slides are available below. You can also find two of his recent papers on blinded adaptations in the 'Related Items of Interest' section.