| |
Why Are So Few
TMD Trials of Adequate Size?
Larger trials cost
more money, and inadequate funding is likely part of the answer
to this question. In some of our trials, for example, the approximate
cost per subject for an RCT with 1 year of follow up at three
time points is roughly $5,000, and that is with a substantial
infrastructure already in place. Costs in industry and NIH-supported
trials are commonly $10,000 to $20,000 per subject.
But expense is probably
not the entire reason for the small sample sizes. Smaller clinics
may not have enough eligible patients per year. Or, overly restrictive
inclusion criteria may limit recruitment. With such restrictive
criteria, it is possible that only 1 in 10 or 1 in 20 TMD subjects
presenting to the clinic may be eligible. Unless a single clinical
site has a large volume of patients, such as over a 100 per month,
such a trial will likely require many years to accrue enough subjects.
|