How COVID-19 Is Driving RWE Uptake In Clinical Trials
With the COVID-19 pandemic exacerbating the challenges of recruiting patients for studies targeting catastrophic diseases and rare cancers, regulators are becoming more receptive to new ways of using real-world evidence in clinical trials.
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It is possible to maintain the current focus on the use of real-world data in drug development by finding simple solutions to existing challenges, argues an expert at a US-based RWD platform.
A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection.
EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.