[HTML][HTML] Real-world evidence for regulatory decision-making: guidance from around the world

L Burns, N Le Roux, R Kalesnik-Orszulak… - Clinical Therapeutics, 2022 - Elsevier
Purpose Interest in leveraging real-world evidence (RWE) to support regulatory decision
making for product effectiveness has been increasing globally as evident by the increasing …

Real-world evidence—current developments and perspectives

F Schad, A Thronicke - … journal of environmental research and public …, 2022 - mdpi.com
Real-world evidence (RWE) is increasingly involved in the early benefit assessment of
medicinal drugs. It is expected that RWE will help to speed up approval processes …

[HTML][HTML] Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: a retrospective …

JM Boyle, G Hegarty, C Frampton… - European Journal of …, 2021 - Elsevier
Abstract Purpose Real-World Data (RWD) studies are increasingly used to support
regulatory approvals, reimbursement decisions, and changes in clinical practice for novel …

Real world data in health technology assessment of complex health technologies

MA Hogervorst, J Pontén, RA Vreman… - Frontiers in …, 2022 - frontiersin.org
The available evidence on relative effectiveness and risks of new health technologies is
often limited at the time of health technology assessment (HTA). Additionally, a wide variety …

Perspectives on emerging technologies, personalised medicine, and clinical research for cancer control in Latin America and the Caribbean

G Werutsky, CH Barrios, AF Cardona… - The Lancet …, 2021 - thelancet.com
Challenges of health systems in Latin America and the Caribbean include accessibility,
inequity, segmentation, and poverty. These challenges are similar in different countries of …

Emerging technologies in public health campaigns: Artificial intelligence and big data

TO Olorunsogo, A Anyanwu, TO Abrahams… - International Journal of …, 2024 - ijsra.net
This research explores the integration of Artificial Intelligence (AI) and Big Data into public
health campaigns, envisioning a future where precision, personalization, and proactive …

A Case for Synthetic Data in Regulatory Decision‐Making in Europe

C Alloza, B Knox, H Raad, M Aguilà… - Clinical …, 2023 - Wiley Online Library
Regulators are faced with many challenges surrounding health data usage, including
privacy, fragmentation, validity, and generalizability, especially in the European Union, for …

[HTML][HTML] Integration of real-world evidence from different data sources in health technology assessment

P Graili, JR Guertin, KKW Chan… - Journal of Pharmacy …, 2023 - frontierspartnerships.org
Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders
involved in the therapeutic product lifecycle but remains underutilized in the health …

[HTML][HTML] Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology …

K Zisis, E Pavi, M Geitona… - Journal of Pharmacy & …, 2024 - frontierspartnerships.org
Objective: This review aimed to assess the current use and acceptance of real-world data
(RWD) and real-world evidence (RWE) in health technology assessment (HTA) process. It …

Use of real-world evidence for oncology clinical decision making in emerging economies

F Petracci, C Ghai, A Pangilinan, LA Suarez… - Future …, 2021 - Taylor & Francis
Real-world evidence (RWE) can provide insights into patient profiles, disease detection,
treatment choice, dosing strategies, treatment sequencing, adverse event management and …