seems like a way off but focussing on the positives
last trial
3 years to enroll, then 24 months to endpoint, 400 patients, 3 groups, complicated endpoint
this trial
1 year to enroll, then 12 month endpoint, 300 patients, 2 groups. >5 years injury excluded, (replicate prior results achieved) simple pain endpoint.
knowns - who to treat, when to treat, what mixture to treat them with, which clinics to do it, how it helps.
this trial is much less exploratory. but its still pivotal, so cant exactly call it a "confirmatory efficacy" trial. i have limited understanding of statistics but i would think (even with reduced enrollment numbers) that by removing 1 treatment arm , and exluding a certain non responding group from enrollment they would more likely achieve a stronger statistical significance between groups than last round.
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