Trial Enrollment Difficulties
posted on
Jul 03, 2012 11:01PM
Edit this title from the Fast Facts Section
"This week the Journal of the American Medical Association (JAMA) published a study entitled Effects of Dietary Composition on Energy Expenditure During Weight-Loss Maintenance. While I’m guessing most readers have not read this study, I’m pretty sure most of you have heard about the results as it was all over the news this week."
...then later in the comments...
"Speaking of which, it’s illustrative of just how hard it is to run a good study to examine their exclusions. They started their screen with almost 700 potential Subjects to get a non-confounded group of 21."
...so I guess we can have some sympathy for the difficulties MNKD is having finding 2 groups of 150 (?) subjects each. By these numbers they would need to screen 10,000 patients to find 300 subjects, and the target population is of a similar type. But even if their success rate is much higher, you can see that it is a big challenge.