Design of Clinical Studies of Pharmacologic Therapies for Alzheimer’s Disease (April 2013)
This EGD on Alzheimer's disease tests a process for developing disease-specific guidance for clinical studies that meet the needs of both payers and health technology assessment bodies.
CMTP worked with the GPC International to develop an Evidence Guidance Document (EGD) on Alzheimer’s disease in order to test an international process for developing disease-specific guidance on the design of clinical studies to meet the needs of payers and health technology assessment bodies.
The guidance provides recommendations regarding the selection criteria, interventions, comparators, outcomes, and follow-up employed in phase 3 and 4 trials of pharmaceutical therapies intended for use in patients with mild or moderate Alzheimer’s disease.
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