Design, planning and conduct of stratification and validation cohorts

PERMIT WP3 hosted two workshops to delve into tools and methods for designing, planning, and conduct stratification and validation cohorts. The workshops were conducted with twelve experts in these fields on 26th and 27th April 2021. We discussed the usefulness of data simulation for determining sample size; the different focus of personalised medicine studies, depending on the type of illness or treatment; the convenience of monitoring associated clinical data; the adequation of genomic data for stratifying; and the mitigation of the risk of bias. In addition, challenging aspects of the planning and design of cohorts were discussed. We concluded that there is a need for recommendations regarding integrating cohort data from different studies, integrating multimodal data profiling studies, and regulation in the stratification stage of personalised medicine studies.