The Green Park Collaborative – International just completed a pilot project that tested 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 collaborative produced guidance on Alzheimer’s disease, and an evaluation of the pilot project that explores the challenges and opportunities of international collaboration on such guidance.

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.