April 28, 2020

Introduction

As the quest to develop more effective treatments for cancer continues, a growing number of therapies are receiving accelerated approval from the U.S. Food and Drug Administration (FDA). The percentage of new oncology drugs that have gone through the Accelerated Approval Program increased approximately 30 percent between 2012 and 2020. Accelerated approval often comes with a commitment for post-approval follow-up safety studies that can extend for many years, and for some treatments, decades. A CAR-T therapy receiving accelerated approval might, for example, require a 15-year follow-up safety study.

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Such long study periods pose challenges for Sponsors and Contract Research Organizations (CROs) in minimizing patient attrition and data loss. At the same time, Sponsors and CROs must develop cost-effective approaches to these studies so that they are sustainable and produce regulator-grade data.

 

Here, we explore how the demands of long-term follow-up studies of oncology therapies are changing and present recommendations for keeping sites and patients engaged in the ongoing research effort.

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