The presentation is intended for Clinical Trial programmers or statisticians who are working on the solid tumor studies in oncology. There are three types of studies in oncology: Solid Tumor, Lymphoma and Leukemia. The solid tumor study usually follow RECIST (Response Evaluation Criteria in Solid Tumor) while Lymphoma follows Cheson and Leukemia follows study-specific criteria. The presentation will provide the brief introduction of RECIST 1.1 such as lesions (target, non target and new) and their selection criteria (size, number and etc). It will also discuss how the changes in tumor measurements will lead to responses (Complete Response, Partial Response, Stable Disease, Progression Disease and Not Evaluable).
Then, the presentation will introduce how RECIST 1.1 data are streamlined in CDISC – mainly in SDTM and ADaM. The presentation will introduce the new oncology SDTM domains - TU (Tumor Identification), TR (Tumor Results) and RS (Response) according to RECIST 1.1. The presentation will also show how ADaM datasets can be created for the tumor response evaluation and analysis in ORR (Objective Response Rate), PFS (Progression Free Survival) and TTP (Time to Progression).