Medical Device Trials

As the largest gathering of medical technology industry professionals in the Midwest, LifeScience Alley’s annual conference brings together over 1,600 global leaders in the medtech and health care industries to build their professional networks, increase knowledge of the latest industry developments, and improve their businesses.  Join other medtech professionals on Dec. 7^th as they share vital information on the shifting commercialization and health care delivery landscape.  The 2011 Conference features two keynote addresses, seven seminar tracks with 14 educational sessions, and an exhibit hall.  Please come and visit The Integra Group at our booth.  Please view the agenda here:

Two recently published surveys on the performance of Contract Research Organizations (CROs) have highlighted the importance of selecting the right CRO to partner with when conducting pharmaceutical and medical device clinical trials. At the same time, however, the surveys seem to muddy the waters on who is actually “the best” CRO for you.  There are three main points to consider when selecting a CRO: relationships, experience, and cost.

At the 2011 Society for Clinical Trials meeting in Vancouver, Canada, a workshop on designing “small clinical trials” was offered.  Christopher Coffey of the University of Iowa and Janet Wittes of Statistics Collaborative presented the information, (along with “surprise guest,” Canadian physician Dave Sackett) based on an FDA/NIH course.  The general lesson of the day was that in small clinical trials, you need to be even more careful and precise about every aspect of the trial.  In larger trials, you can afford a little sloppiness, because the large sample size smoothes away some of the rough edges.  But in small trials, every data point counts.  You are trying to “squeeze precision from a stone.”  There’s only so much you can get from a limited sample size, so it’s important to do it right and get as much out of it as you can.

I sat on a panel titled Serving 2 Masters: CMS and the FDA - One Clinical Trial: Two Different Needs at yesterday’s MedTech Investing Conference with Dr. Dan Schultz (Greenleaf Health), Dr. Richard Baer (Emerson Consultants), and Gary Goetzke (Celleration). The discussion focused on similarities and differences between FDA and CMS requirements for clinical trials. Together the panelists explored opportunities for medical device companies to carefully design clinical studies to meet both sets of requirements.