IMI Get Real work package 1 Case Study
Our analysis focused on mentioned uncertainties in the clinical evidence that emerged from regulatory and reimbursement assessments for COPD drugs approved by the EMA, Health Canada (HC), and/or the Therapeutic Goods Administration (TGA) between 2010 – 2015. We categorized the agencies' questioning of uncertainty around validity and applicability of efficacy data to help inform a decision-making framework for including RWE earlier in drug development to reduce such uncertainties.
Read full analysis and conclusions in the research brief.
Original research presented at ISPOR 2016 in Washington, DC.