Posted by Michael Wonder on 11 Aug 2019
The evolution of real world studies
9 August 2019 - The use of real-world evidence is evolving quickly.
Having cut their teeth using real-world evidence (RWE) to validate safety post-approval, companies are increasingly interested in using evidence of real- world efficacy to win approval in new indications, leading to landmark regulatory decisions for drugs including Pfizer’s Ibrance. Regulators on both sides of the Atlantic want to facilitate RWE use but barriers including infrastructure limitations and data quality concerns remain.
Pfizer and the FDA shed light on the evolution of RWE in April when breast cancer drug Ibrance secured approval in a new indication on the strength of data from electronic health records (EHRs) and other real-world sources. Analyses of real-world tumour responses and safety data persuaded the FDA that Ibrance is safe and effective in men, leading it to expand the label.
