ABSTRACT
As randomized clinical trial (RCT) programs have increasingly become more global geographically, numerous challenges have resulted [1]. One issue that arises with such global programs is the sometimes differing regulatory advice or requirements on primary or secondary endpoints [2]. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has recognized this with the ongoing development of ICH E17 guidelines on the general considerations for the design of multiregional clinical trials. It is largely a function of the inexact science of medicine that health authorities with diverse healthcare systems do not always agree on which endpoints should be primary to evaluate a patient’s response to a treatment for a specific disease, and therefore for a specific treatment development program. Even when there is agreement on the clinical measurement, there may not be agreement on the specific details in defining or analyzing that endpoint.
