Unlock patient access to transformative therapies by addressing one of the principal evidence barriers to reimbursement: establishing when departure from the randomized controlled trial (RCT) standard is scientifically justified and how treatments should be evaluated when only non-randomized evidence is available

Led the international Meeting of the Minds initiative, convening senior leaders from regulatory agencies, HTA and reimbursement bodies, industry, academia, and patient organizations to develop a shared framework for evidence generation and evaluation beyond the traditional RCT paradigm.

Published internationally developed criteria for when deviation from the RCT standard should be considered scientifically acceptable, together with a methodological framework for generating and evaluating credible comparative evidence. The initiative has since expanded to address post-launch confirmation of long-term effectiveness, durability, and value.