Enormous progress has been made globally in the use of evidence derived from patients'
clinical information as they access their routine medical care. The value of real-world data …

Background When a new drug becomes available, patients and doctors require information
on its benefits and harms. In 2011, Germany introduced the early benefit assessment of new …

Purpose Regulatory agencies and other stakeholders increasingly rely on data collected
through registries to support their decision‐making. Data from registries are a cornerstone of …

Real-world evidence (RWE) is clinical evidence on a medical product's safety and efficacy
that is generated using real-world data (RWD) resulting from routine healthcare delivery …

1 BACKGROUND The European Medicines Agency (EMA) has the responsibility for the
scientific evaluation, supervision, and safety monitoring of medicines in the European Union …

Information derived from routinely collected real‐world data has for a long time been used to
support regulatory decision making on the safety of drugs and has more recently been used …

Background. Since 2011, when the German Pharmaceutical Market Restructuring Act
(AMNOG) came into effect, newly licensed pharmaceuticals must demonstrate an added …

Real-world studies have become increasingly important in providing evidence of treatment
effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold …

We outline our vision that by 2025 the use of real-world evidence will have been enabled
and the value will have been established across the spectrum of regulatory use cases. We …

Objective Phase IV trials are often used to investigate drug safety after approval. However,
little is known about the characteristics of contemporary phase IV clinical trials and whether …