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Adaptive Designs in Pharmaceutical Research
Join Karen Kesler, one of Rho's experts in Adaptive Designs, as she reflects on the current state of Adaptive Designs in pharmaceutical research. She'll cover topics such as FDA preferences, regulatory concerns, biostatistical considerations, and protocol implementation logistics. We look forward to hearing from you as we discuss and shape this emerging field together.
My Friend Frane
“Many randomized studies in small patient populations and studies in early research (such as Phase I and Phase II trials) have small to moderate numbers of patients. In such studies the use of simple randomization or blocking on only one or two factors can easily... [more]
Futility is Not Equivalence: A Lesson in the Interpretation of Results
I had this fascinating discussion with one of my colleagues this week about the Whitehead boundaries and the interpretation of crossing the futility boundary. I had always treated the area below the futility boundary as the null hypothesis acceptance region and glossed over the fact... [more]
Everything Old is New Again: A List of Some (not so new) Adaptive Design Resources
Although we are used to thinking of adaptive designs as new, some of them have actually been around for awhile. The PhRMA white paper series (DIJ 2006 40 (4)) includes group sequential designs and adaptive randomizations. Statisticians have been working on these methods for decades.... [more]
