External Controls In Research

UBC, a leading provider of pharmaceutical support services, convened a virtual gathering of experts for an invigorating discussion on the use of external comparators in clinical research and post-marketing programs. This discussion lead to the creation of an External Controls in Research Series that will be released in segments, whereby our experts respond to key questions relating to the what, why, and how of the use of external comparators.

The discussion included a group of experienced biopharmaceutical development professionals including epidemiologists, statisticians and data scientists exploring essential considerations in generating evidence on the safety and efficacy/effectiveness of treatments using external comparator groups in the study design.

In this External Controls in Research Series, we will be exploring various topics such as the historical decisions of regulators in accepting results from studies using external comparators; what factors should be considered when selecting optimal data source(s) to identify patients for the comparator group; and the future of external comparators in drug development. Comparing outcomes of patients in an appropriate external comparator cohort with outcomes of the study population allows researchers to accelerate evidence generation and achieve a range of clinical development objectives.