Prospective Non-Interventional Studies and Real World Evidence

Real-world evidence is becoming critical to establish effectiveness, long-term drug safety, quality of life, resource use, and to determine the impact of a healthcare intervention on the treatment pathway of local population. It can also determine the effect that a healthcare intervention has on outcomes for patients who may be excluded from randomized controlled trials. The addition of real-world evidence to clinical trial evidence provides a comprehensive dataset for healthcare system stakeholders to make decisions about whether a treatment should be approved and reimbursed. Thus, an important part for companies’ value proposition with payers..

We focus on “Real-World Evidence” (RWE) meaning evidence coming from registries, electronic health records (EHRs), and insurance data, where studies may be required by regulators and the subsequent results are used to inform potentially HTA decision-making.

Real World Evidence through the natural life cycle: