Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what …
Road map of real world evidence (RWE) in Europe
Several European countries have been utilizing big data together with randomized control trials to guide healthcare decision making and to address market access issues. The Region Europe RWE Advisory Board was formulated to explore potential areas of real world evidence (RWE) use in countries like UK, France, Portugal etc. The board engages …
The pharma lens on real world evidence (RWE) for payer and patients
Real World Evidence (RWE) helps payers make reimbursement decisions and assists patients in budget management and estimating risk benefit of interventions. The integration of RWE in value assessment frameworks, used for ascertaining drug value, can help payers make informed evidence-based reimbursement decisions. RWE provides insight into real world impact of an …
Real world evidence (RWE) and market access in the US
Randomized control trials demonstrate drug safety and efficacy and hence are fundamental for regulatory approval. However, real world data (RWD) becomes a progressively more important source of evidence as we move across the development continuum of a drug. RWD can be potentially useful for obtaining regulatory approval as well. Communicating …