We recently discussed how cardiovascular device innovation is slowing in our webinar, 5 Steps to Success for Your Cardiovascular Medical Device Trial. This trend can be attributed to a variety of factors such as rising development costs and additional time needed to bring devices to market and a movement toward larger, longer and more complex clinical trials due to expanding regulatory requirements.
To get a better understanding of the specific issues that pose the greatest challenges when conducting global high-risk medical device trials, we polled our participants. Here are the results:
- Regulatory compliance – 38 percent
- Standards for diagnosis and care – 38 percent
- Cultural, language barriers – 12 percent
- Import/export – 4 percent
- Other – 8 percent
Unsurprisingly, regulatory compliance and standards for diagnosis and care account for more than three-quarters of participants’ biggest concerns. As many of you have experienced firsthand, both areas frequently experience change as they expand and modernize to meet the unique needs of today’s trials.
While using FDA standards for safety monitoring, data quality, endpoint definitions, sample size calculations and follow-up is often a smart approach, one should also be aware of any possible changes. While global regulatory bodies are likely to accept these standards, they are constantly in flux. Trials started today will still need to meet the regulatory expectations of the future.
Beyond potential regulatory changes, there may also be additional local requirements, despite compliance with ICH-GCP requirements, regarding standard of care, post-study medication access and minimum insurance coverage levels for enrolled patients. For example, some countries, including China and Japan, require clinical testing in local patient populations prior to product registration.
It is important to take into account differences in standards of care when conducting multinational trials, including:
- Use of background medications in one population but not another can impact generalizability of results
- Rates of reported AEs may be affected by cultural differences (eg, stoicism, reluctance to complain)
- Standards for diagnosis also vary across regions, and sponsors should consider local requirements for diagnostic testing and/or imaging and validate radiology and other technical equipment before study initiation
For more information on global challenges in the clinical development for interventional cardiovascular devices and how to overcome them, please download the webinar slides and be on the lookout for an upcoming eBook. If you’d like to be alerted when the eBook is available, please leave your contact information in the comments section.