Public-private project to give patients a voice in drug development

Uppsala University and Swiss pharma giant Novartis (NOVN: VX) lead a new public-private research project "Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)" under the Innovative Medicines Initiative (IMI), which was launched this month.

Drugs are developed for patients and there is an emerging consensus that they should be involved in determination of benefit-risk considerations during the life cycle of medicinal products. The patient voice is becoming increasingly important, not only for the companies that develop new therapies, but also for the authorities that assess, regulate and decide which drugs are effective, well tolerated and cost-effective for patients and the community.

Industry, regulatory authorities, health technology assessment bodies, reimbursement agencies and patient organisations are in agreement regarding the high value of patient preferences. However, there is little guidance on conducting and using such studies in pharmaceutical industry, regulatory and reimbursement decision environment. PREFER will provide a set of systematic methodologies and recommendations to assess, engage and include patient perspectives during the development, approval, and post-approval of new therapies.