The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD) characteristics, and of course identify the maximum tolerated dose (MTD).
Conventionally, SAD and MAD studies were conducted separately, but increasingly are combined into an ‘umbrella’ protocol which addresses both SAD and MAD objectives.
At the recent JSM meeting in Chicago, Cytel's Jim Bolognese presented the results of work he has conducted evaluating the T-Statistic ( or T-Stat) method for adaptive dose finding of MTD. In this blog we'll provide a brief summary of Jim's findings, and share his slides with our blog readers.