The Future of Pharmacovigilance: Proposals for More Efficient and Effective Systems-Based Approaches

Abstract

Clinical research is at a cross-roads of sustainability due to the current cost of development, amount of regulation, and irrational use of medicine. There are also too many silos in clinical research and development, post-marketing safety, as well as a lack of standards, and effective communication. This paper covers the future of pharmacovigilance and argues that it needs to re-focus and not be a silo in the last phase of clinical research. In fact, the integration of pharmacovigilance is an integral part of much needed change in clinical research and development based on the application of systems thinking. Clinical research and development must improve as a whole system through the synergy of all parts.