Industry sponsored medical device clinical trials

Abstract

The total number of industry sponsored medical device trials registered with the US trial register between October 2005 and June 2009 was 1,017. The majority (30.5%) of the sites belonged to phase III trials, followed by clinical studies not characterized by means of trial phase (29.1%), but still being interventional studies. The total number of sites for all study types and study status was 7,276 – with the largest number (n=2,221) for phase III trials, 2,116 for not defined trial types and 1,975 for phase IV trials. North America contributes 4,556 sites representing 62.6% of all sites globally. Europe accounts for 2,051 sites (28.2%). The remaining 9.2% are predominantly located to Asia (3.0%), with 1.2-1.4% to Oceania, East Europe, Middle East and Latin America. There are 437 industry sponsors of the 1,017 trials registered, averaging fewer than three trials per sponsor. Only 55 sponsors had four or more registered trials. Cardiovascular devices stand out as the dominant therapeutic area with 35.5% of all trials, 47.3% of all sites and 62.5% of all subjects. Other important areas are orthopaedics, ophthalmology and endocrinology. The top 10 pharmaceutical companies had combined revenue of US$263.5 billion – or more than 10 times the sales of the top 10 medical device companies. Clearly, the market for drug development is far greater than for medical devices, a fact reflected in the activity level of clinical research between those two medicinal product areas. The vast majority (90.8%) of medical device trial sites are located to North America and Europe and only a small share to the rest-of-world. The globalization process of clinical research is thus more international for drugs and biologicals than for medical devices.