ISSUE: Clinical trials designed for regulatory approval rarely adequately cover the evidence needs for reimbursement and health technology assessment. OVERVIEW: Clinical trials are mostly designed to establish the efficacy and safety of medical therapies, upon which regulatory approval can be sought. However, more and more markets are seeking evidence of cost-effectiveness, upon which to base reimbursement decisions. There is therefore an increasing need for trials to capture relevant health economic outcomes, including long term efficacy/safety data, quality of life, health resource utilisation and costs. This panel session will explore the need for, and development, ‘smarter’ trials and corresponding methodology for analysing these trials in order to meet both regulatory and reimbursement requirements. The panel will comprise of experts from regulatory, reimbursement evaluation and industry.