I am looking forward to the International Congress on Clinical Trials for Medical Devices in Berlin later this month, where I will be talking about the globalization of clinical trials and mutual acceptance of foreign clinical data for regulatory and guideline purposes.
An abstract concerning my presentation you can find on the website of CTMD 2016. In short, I am intrigued to see that while advancing technologies, and international guidelines facilitate the extrapolation of clinical data from one region to the other, the changes with respect to acceptance of foreign data seem to be minimal. Especially in the US where > 60% of the safety and effectiveness data for PMA’s originates from US soil only over the last 15 years.
It seems that the benefits are outweighed by other factors, such as intrinsic and extrinsic ethnic differences. As these might well be hard to overcome, I wonder whether, in medical devices, we should introduce the concept of bridging studies similar to what is done for medicinal products. I am looking forward to the discussions, and please do not hesitate to contact me at Applied Clinical Services.com when looking for support for your medical device study.