Clinical trials for rare disease therapies face many challenges. Some of these include the small patient population on which they draw, the fact that often there may be many unanswered questions about a specific disease, and the potential variation in the way a rare disease manifests itself in patients. We spoke to John Boland, Vice President of Product Development for the Atlantic Research Group, about the contract research organization’s recent white paper on “Critical Considerations for Rare and Orphan Disease Trial Planning.” (bit.ly/2qE2qpb)
We also learned about some of the special challenges of conducting rare disease clinical trials and how to best address them.
RARECast is a weekly series by Daniel S. Levine. Levine is an award-winning business journalist who has reported on the life sciences, economic development, and business policy issues throughout his 25-year career. He founded Levine Media Group in 2013, which produces The Bio Report and RARECast podcasts. Read his full bio here.