The Global Core Clinical Protocol and its Rational Adaptations

Abstract

The trend towards worldwide and almost simultaneous clinical development of a new drug has created the need for intense coordination of clinical protocol design among groups. Goals of global clinical research activities are to obtain economies of scale in bringing the new drugs to the populations in need quickly and to avoid national drug lags. Thus, clinical activities of this nature aim to rapidly build a file of broad-based data from comparable studies. This will, hopefully, enable data from several countries to be submitted for registration purposes in each, and to detect regional differences in dosage, efficacy and safety early, if any.However, to arrive at such a uniform output in a fast and flexible manner requires strong consistency in protocols, beyond what may be globally feasible under current operating conditions. National studies may need to cater to honest differences of opinion or experience, particularly of national leaders, or may need to be geared to provide the locally obtained evidence...