I recently participated as a panelist in an event organized by the PLEXUS Innovation Hub in Philadelphia to discuss the business, regulatory and clinical considerations of conducting clinical trials and product launches in the US and outside the United States (OUS) for medical device and technology companies. We had a knowledgeable group of industry folks on the panel, and it was a pleasure being part of this group.
Our discussion revolved around considerations to take into account when small/start-up companies are deciding between US or OUS for first-in-man studies and product launches. I took away three key insights including:
- Clearly outline therapeutic area, patient population(s), and protocol requirements–Begin developing your strategy by defining the the elements that are critical to your clinical development and market launch success. Evaluate the options that will help you achieve your goals quickly, effectively, and in a cost-conscious manner.
- Confirm a strong regulatory infrastructure–It’s imperative to do your due diligence, and to make sure the country you’re considering has a strong regulatory framework and process.
- Ensure study sites and staff are trained and follow industry standards for conducting clinical research–In order to protect the rights, safety, and well-being of trial subjects and ensure the clinical trial data are credible, it is imperative that the study sites follow International Conference on Harmonization (ICH)/Good Clinical Practice (GCP). The ICH guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
Additionally, the FDA issued draft guidance in 2015 outlining their policy for accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices.
What do you think? Do you have similar thoughts on the key areas to consider when determining to conduct your trials in the US, OUS, or a combination of both? I’d love to hear your thoughts and ideas on this topic in the comments section.