PRA recently performed a feasibility study to identify investigators who see patients with a rare neuromuscular autoimmune disease and who have the capability to perform a Phase II clinical trial. It was estimated that there may only be 1,000 to 3,000 patients in the US and Europe with the condition. By identifying 88 interested investigators and areas of high prevalence during the feasibility study, PRA and the sponsor developed a unique, data-based strategy for the clinical program.
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Download this resource to learn how to conduct studies with patients who lack legal competence and the 4 ethical pillars of medical research.