This is a question that we hear often. I ran across this article in Healing Innovations that takes a look at why early clinical studies are often performed off shore. According to FDA’s website, typically “pilot studies involve a limited number of subjects and sites, and close monitoring of all adverse events. The size and duration of the pilot study can vary depending upon the type of device being investigated.”
It is not a secret that most medical device companies perform pilot studies outside the United States (OUS). The stated reasons are many:
- Cost reductions
- Avoiding a protracted FDA IDE
- Ability to make design changes
- Not having to make continual IDE amendments
There are many factors that help drive down the cost on an OUS study. Namely, factors include: reduced hospital, physician and investigator, diagnostic exam and operating room expenses. Another key cost variable is CRO, but the article stresses that you must be cognizant of the quality and language barriers. But, cost alone is not the only reason to consider OUS.
The article stresses that a critical obstacle in a U.S. based study is the inconsistency of the FDA review teams. Every group and review team at the FDA has its own personality – some groups can be difficult while others have a more collaborative approach. The length of the review time can be dictated by the overall personality of the FDA team. The more difficult the team, the longer the review process can drag out.
The Health Innovation article stresses that one of the most compelling reasons to go OUS is it provides you with design flexibility. OUS pilot studies provide you with an opportunity to refine your design and gain critical insight. Foreign FDA counterparts typically do not require amendments unless the design change impacts patient safety. Conversely, design changes for U.S. based trial can have an impact on trial length and costs.
The article stresses that you should not exclude a U.S. pilot study, but to think strategically about the early study design and understand that you have OUS options in countries with a strong track record.
What are your experiences with US and OUS pilot studies? Do you have any recommendations to share? Please feel free to leave a comment below.
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