How post-authorization studies have become a crucial part in drug development

In our weekly expert view piece, pharmacovigilance team leader at Berlin-based CRO, KCR, examines the increasing benefits of post-authorization studies and the collection of real-world data.

Time and costs of bringing a medicinal product to market have risen rapidly over the last two decades mainly as a result of increasing regulatory and scientific requirements on clinical development. Maintaining the highest quality standards of the clinical research improves the chances for an efficient marketing approval process, however expanding the time and complexity of pre-authorization procedures is not the proper method to satisfy the growing need for early access to innovative, advanced therapeutic options.

Post-authorization safety studies (PASS) have recently become critically important in the context of real-world data collection, simplified authorization procedures and early access to new and safe therapies.