New research raises more questions about whether medical device manufacturers are completing required clinical trials, which are supposed to ensure that their products are safe and effective.
In a study published in the Journal of the American Medical Association (JAMA) on August 11, researchers from Yale University report that only a fraction of post-market clinical trials required by the FDA for high-risk medical devices are actually being completed.
The new study comes as the FDA seeks ways to get medical devices to the market even faster, and with more flexible clinical trial requirements that are more accommodating to medical device manufacturers.
Researchers in the latest study looked at data on high-risk therapeutic devices that received premarket approval by the FDA in 2010 and 2011, determining whether manufacturers had completed required post-approval studies (PAS), which are conducted after the device is already made available to healthcare professionals and consumers.
The findings indicate that only six of 33 PAS studies required by the FDA were actually completed, and only 20 of 171 manufacturer/investigator-initiated post-market studies were reported as complete.
“Among high-risk therapeutic devices approved via FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between 3 and 5 years after FDA approval,” the researchers concluded.
The findings come about two months after an analysis published in BMJ found numerous discrepancies in data submitted to the FDA by medical device manufacturers seeking premarket approval for cardiovascular devices. Those discrepancies often included the number of participants varying in the actual study from the number reported to the FDA, substantially different results from similar FDA studies, and many of which were never peer-reviewed.
The findings also came at about the same time as the FDA released a new report on it’s role in medical device safety. The agency says it has made significant strides in ensuring medical devices are safe and effective, including in how it reviews and requires clinical trials.
“Over the past five years, the Food and Drug Administration’s device program has shown a pattern of markedly improved performance,” the executive summary states. “Today it is performing strongly across a wide range of performance measures.”
However, the FDA report indicates that the agency wants to “streamline” the clinical trial approval process and get the devices on the market even faster. To do so, the agency is considering allowing adaptive clinical trials and more flexible trial requirements.
The latest study found that, in general, the FDA already relied on only one study per device.
Researchers cited problems with metal-on-metal hip replacement systems as one indicator as to the importance of postmarket approval studies.
Thousands of metal-on-metal hip replacement lawsuits have been filed in recent years throughout the U.S., alleging that the manufacturers failed to adequately research the design or warn about the large number of implants that were failing within a few years and requiring revision surgery.