The Evidence Base rang in the new year with a look back at the real-world evidence (RWE) landscape of 2021. In this retrospective, Darcy Hodge highlights the FDA’s push for clear RWE standards in clinical trials and approval applications. In addition, she examines how the rise of RWE in 2021 was inexorably tied to the COVID-19 pandemic.
Hodge writes, “February saw the ‘vaccine race’ begin, albeit much more pressing than man’s journey into space. Once again RWE was shown to make one small leap in research, but another large step for humankind. RWE research crucial for the global vaccination program was initially pre-printed in February and was later printed in the August edition of the journal Med. The real-world study highlighted that two vaccine brands had their efficacy reinforced by RWE, following their approval by the FDA.”
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(Source: The Evidence Base, December 23rd, 2021)