A recent report, “Trial designs using real-world data: The changing landscape of the regulatory approval process,” calls for hybrid trial designs to produce regulatory-grade real-world evidence.
According to a pharmaphorum report, the report’s authors propose meshing parts of randomized controlled trials and observational study designs.
“We see a growing need to contextualise clinical trial data, particularly for niche conditions where it is not feasible and sometimes not ethical to randomise patients,” Nancy Dreyer, IQVIA CSO and co-author of the report, said.
Click here to read the report.
To read pharmaphorum’s article, click here.