The medical device marketplace is all about FDA clinical trials, determining whether a device creates good patient outcomes and is reimbursable, and the avoidance of economic risk. These factors, interestingly, bear in a significant way on the manner in which clinical trials for medical devices are conducted, according to speakers at the May 7th Annual Meeting of MassMEDIC held at the UMass Boston Campus. (MassMEDIC is the association of manufacturers of medical devices).
First it should be noted that some devices can be FDA approved if they are sufficiently similar to prior devices, without conducting clinical trials. Further, extended double blind clinical trials are generally less indicated for devices than for drugs; drugs are ingested into the system and may impact safety in “off target” areas, while the impact of devices typically is local and can be observed directly and more simply.
One of the pushes in designing faster U.S. trials is the presumed trend to conduct trials in the first instance in Europe, of even in Asia, where regulatory difficulties are less extreme. In the United States, particularly if there is a “dangerous” possibility in the trial, satisfying FDA is indeed a longer process and consequently bringing a product to market will take longer here.
All that said, various trade groups are working with the FDA to speed up the process by using “single arm” trials (a single treatment is evaluated). Another push is to speed the process by going directly to human testing, without prior animal studies, with respect to smaller groups of subjects.
Cutting through all of this is the reality that United States studies often fail to achieve targeted enrollment; 45% of proposed studies, according to a 2013 Harvard University survey, failed to fully fill; 15% of these studies received absolutely no participation.
Another trend is toward “adaptive” study design. The FDA has been approving these studies in certain cases, eliminating pilot studies, collapsing the process, and allowing the design of the study to be modified, as it proceeds, based upon the data obtained in preliminary indications. This allows speeding up the study that is clearly promising, or reducing the sample size as you go forward.