Procurement and Distribution of Study Medicines

Abstract

When compared to clinical trials involving a new (unapproved for human use) drug or biologic, utilizing an approved, commercially available medication in a clinical trial can introduce a new set of variables surrounding procurement and distribution, all of which are fundamental to successful trial implementation. Numerous procurement factors must be considered, including the identification of a suitable vendor, manufacturing of a matching placebo, and expiration dating, all of which can become more intricate when the study increases in complexity by involving factors like active comparators, drug tapering regimens, and research sites in more than one country. Distribution is a similarly complex operation, which involves adherence to regulatory requirements and consideration of aspects such as blinded study designs or utilization of additional safeguards with the use of controlled substances. This chapter will review the basic factors to be taken into consideration during the planning and operational stages of a clinical trial involving a marketed medication and provide examples of how to manage these factors, all of which are aimed at ensuring compliance with both applicable local and international laws and with guidance documents aimed at protecting the rights, safety, and well-being of trial participants.