Post-trial access to treatment: How managed access programs could be a solution

Abstract

The rising cost of clinical development, coupled with the ethical obligation to ensure that patients exiting a clinical trial are able to remain on active treatment if necessary, has led some pharmaceutical and bio-pharmaceutical companies to review their trial protocols and consider alternative options. The traditional open-label extension or phase IV trial is appropriate in some instances, as is a post-trial supply program using the legislation available for unlicensed medicines in the many countries around the world. This article looks at some of the key considerations and how many companies are adopting different supply models.