August 21, 2020

Introduction

Rare disease drug development is one of the fastest growing areas for biopharmaceutical investment and research, but the research and commercialization challenges inherent to rare disease product development present significant risks that sponsors must anticipate and navigate to be successful.

 

This paper provides an overview of proactive global clinical trial feasibility assessments, to make the case that such an assessment can yield valuable information regarding patient recruitment and site selection for rare disease clinical trials as well as every other aspect of drug development and market access. We also discuss the pros and cons of using a “proactive global feasibility” approach, and offer suggestions on how to improve the process based on the authors’ experience when conducting such studies. We also offer an additional perspective on alternative tools in our feasibility armamentarium, such as digital patient identification methods.

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