a reverse double blind trial structure is the kind of thing I'd like to have seen used in the NEU ph III trial, if only that it rewards the trial participants by "giving everyone a go"
I see two negatives to a crossover trial.
The first is longer trial duration. The mecasermin trial was a 20 week drug + 28 week washout + 20 week placebo + 4 week follow-up routine. That’s almost 18 months per patient. With just 30 patients, the mecasermin trial took almost 4 years to complete. Do the math….if the Ph 3 trofinetide trial uses even longer dosing periods (26 weeks) and has at least 4 times as many patients….
The second potential problem with a crossover trial design is carry forward effect. The authors stated that they could not rule this out as a cause of the mecasermin trial failure.
$$, page-47
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