Understanding ADAPT in the SDTM TS Domain: Adaptive vs Non-Adaptive Trials
Understanding ADAPT in the SDTM TS Domain: Adaptive vs Non-Adaptive Trials Understanding ADAPT in the SDTM TS Domain: Adaptive vs Non-Adaptive Trials The Study Data Tabulation Model (SDTM) plays a critical role in organizing and submitting clinical trial data. One of the parameters that regulatory agencies look for in the Trial Summary (TS) domain is the ADAPT parameter ( TSPARMCD=ADAPT ), which indicates whether the trial follows an adaptive design. In this blog post, we will explore the meaning of ADAPT and provide examples of adaptive and non-adaptive trials. What is ADAPT in the TS Domain? The ADAPT parameter identifies whether the clinical trial is adaptive ( ADAPT=Y ) or non-adaptive ( ADAPT=N ). An adaptive trial allows for modifications to the study design based on interim results, making the trial more flexible and often more efficient. "Adaptive clinical trials allow for changes in design or hypothe...