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 afire of broadbased data from comparable studies. This will, hopefully, enable data from several countries to be submitted for registration purposes in each, and to detect regional diyferences in dosage, efficacy and safety early, i f 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, necessary for national registration or qualification for reimbursement. Also, diyferent drugs or dosage regimens may need to be considered as standards and the acceptability of the inclusion of placebo may be questioned because of local ethical or scientific standards. Such adaptations have to be made with speed and flexibility, while maintaining a central system for data storage and analysis. The various relationships of protocols for a core global program with their national adaptations and deviations from global plan that do not affect objections, design, intervention or success/failure criteria, and that are deemed necessary to adapt a master plan to local needs are presented. The options for centralized v decentralized type management for such a program are discussed.