Tagged with RWE,

Japan Real-world data (RWD) offers the possibility of providing important information to help inform regulatory decision-making. But turning this possibility into reality still depends on the quality and reliability of the data, say J&J’s Yumi Wakabayashi and Vicky Han in October 2023’s DIA Global Forum magazine. With appropriate efforts to ensure…

Europe Writing in the DIA Global Forum’s special November 2022 issue on the Digital Virtuous Loop Karin Van Baelen and Susan Sandler – both of Janssen – and AbbVie’s Álmath Spooner look at Europe’s progress towards true real-world evidence integration and its potential impact on decision making across the healthcare continuum.…

Global One of the enduring conundrums around ground-breaking and potentially paradigm-shifting treatments such as CAR-T is the ever-thorny question of how fast to move them to market when the promise seems so great, but the evidence remains so patchy.   So far, top tier regulators such as the US FDA and…

Opinion Nigel Hughes of the European Health Data & Evidence Network (EHDEN) outlines EHDEN’s scope and purpose and highlights why greater collaboration on real-world data (RWD) will be crucial to ensuring better global health outcomes.    Ultimately, EHDEN is striving to ensure 21st century research can be conducted with 21st century…

Opinion Holmusk’s Nawal Roy highlights the increasing recognition of the value of real-world evidence (RWE) by both innovative pharma companies and drug regulators and its potential to increase market capture and profitability.   RWE has the potential to expand the market size of a disease and accelerate market capture of a…