Tagged with RWE

China Writing in the July 2024 edition of DIA’s Global Forum magazine Mingcan DU and Fengyun (Vicky) HAN of Johnson & Johnson Global Regulatory Policy and Intelligence look back at the evolution of the use of real-world evidence (RWE) in regulatory decision-making in China, including key use cases and future prospects.…

Global Writing in the June 2024 edition of ISPOR’s Value in Health journal, Nancy J. Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD look back on the history of QALYs in cost-effectiveness analysis and policy decision making, and why the backlash against QALYs in the United States…

Global ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), and PharmaBoardroom’s content partner, continues to monitor healthcare trends and conduct horizon scanning around the world. The “ISPOR 2024-2025 Top 10 HEOR Trends” marks the fifth publication of the Society’s biennial report, which is based on input from its members…

Europe The EMA’s Peter Arlett looks back on two years of the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to improve the environment for clinical trials in the EU by transforming how trials are initiated, designed, and run. In conversation following DIA Europe 2024 in Brussels,…

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…

Global Emerging cell and gene therapies herald immense clinical value for patients, society, and healthcare systems: carrying the potential to offer life-changing solutions for people with few or no alternative treatments. Given the limited amount of long-term evidence for these therapies due to their relatively recent development, however, bringing them to…

Norway Anette Margrethe Storstein MD PhD of the Norwegian Brain Council introduces the burden of neurodegenerative disease in Norway today, the ongoing impact of the country’s National Brain Plan, and Norway’s untapped potential in neuroscience R&D.   Norway has unfulfilled innovation potential. There is a lot to be gained from an…

Norway Norway, more well-known internationally as an innovation hub for oil & gas and marine biology, is attempting to reverse the trend of reducing numbers of clinical trials and cultivate a domestic healthcare research industry. Drawing on the country’s comprehensive health registries, universal healthcare system, links with its Nordic neighbours, and…

Norway Ole Alexander Opdalshei introduces the role of the Norwegian Cancer Society within Norwegian cancer research, care services and information dissemination; how medical research charities are able to direct funding towards areas of cancer research missed by the private and public sectors; the burden of cancer within Norway; and the introduction…

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…