Keywords: Interim data reporting
Room: Marriott Balcony A
With more studies being designed with an adaptive component, accurate and timely tables, listings, and figures (TLFs) are essential to be able to make informed decisions about the trial. Reviewing interim data has its own set of challenges. This group will discuss the approaches when preparing TLFs prior to DBL in order to provide study leaders the information they need to make the adaptive design of the study possible.
Question 1) What strategies have you used to balance the issues of quality of the data versus the need for timely reporting? Do you use the full C DISC reporting model (SDTM and ADaM), or are there alternative approaches that are better suited for interim analyses?
Question 2) Have you worked on a trial where the interim measure for decision-making is different than the study endpoint? Question 3) How do you provide the decision-makers the confidence in the interim TLF summaries that support their decision?