Real World Evidence in Japan

Real World Data (RWD) is patient data collected outside of a randomized controlled trial (RCT) to understand how existing medicines and treatments work outside clinical trials. RWE data demand is increasing as payers demand huge amount of data defining value and effectiveness of medicines. This has led to increasing demands of data sources like EHRs, Patient Registries, Databases, etc.� In Japan government pays 70% of healthcare expenses of citizens. Due to various reasons like higher proportion of geriatric population, increasing number of natural calamities, continuously increasing medical cost is increasing burden on government. As a result there is demand of demand of RWE data for reimbursement of drugs is increasing in Japan. Pharma companies procure RWE data mainly from paid database from government, hospitals, etc. but they lack uniformity of data. Pharma companies can collaborate with data providers in Japan for continuous supply of uniform RWD.   Introduction to RWD/RWE Real World Evidence (RWE)/Real World data (RWD) is patient data collected outside of a randomized controlled trial (RCT), often for non-research purposes (e.g., electronic medical records (EMRs), claims data). Real world data are observations of effects based on what happens after a prescriptive (treatment) decision is made where the researcher does not or cannot control who gets what treatment and does not or cannot control the medical management of the patient beyond observing outcomes. Unlike controlled clinical trials, real world evidence studies use observational data such as electronic medical records, insurance claims information and patient surveys. By examining data associated with the delivery of care, real world analyses can assess how various treatments impact how long patients stay in the hospital, whether they are readmitted to the hospital, a patient's overall health status, cost of care and other key evidence-based outcomes.   Author: Harsh Parikh