The clinical development process in the life sciences industry has historically focused mainly on fulfilling regulatory requirements, with the expectation that positive reimbursement decisions would generally follow. However, the past decade has shown the impact payers and Health Technology Assessment (HTA) bodies can have on the development and adoption of drugs, devices and diagnostics.

The Green Park Collaborative (GPC) is an international, multi-disciplinary pilot initiative to explore the scientific feasibility of developing guidance for the life science industry on the design of clinical studies to meet the needs of both HTA organizations and coverage bodies. The GPC operates under the direction of a multi-sectorial international steering group co-chaired by the Center for Medical Technology Policy (CMTP) and Health Technology Assessment International (HTAi).  ICER is serving as the initiative’s scientific secretariat.

ICER has performed background research on documentation regarding Alzheimer’s drug treatments from multiple perspectives, including regulators, HTA bodies, public and private payers, clinical associations, and patient advocacy organizations.  ICER’s draft report outlines the clinical framework and compares stated gaps in evidence for Alzheimer’s drug treatments across countries and perspectives to highlight areas of consensus and disagreement.  Finally, this information is used to make research recommendations to close important gaps.  The final product is expected to describe specific clinical study design methodologies that will have the best chance of producing robust evidence to guide clinical and policy decisions on drug treatments for Alzheimer’s disease.