COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of the potential effects of these changes is the more strategic use of real world evidence to support evidence generation for regulatory approval of clinical trials.
Dr. Radek Wasiak, Chief Data Officer at Cytel and Sreeram V Ramagopalan, Roche, recently co-authored a publication in the Journal of Comparative Effectiveness Research (JCER) on this likely development. The mix of delayed trials, missing data, and other challenges to traditional statistical design has meant that new tactics need to be deployed to salvage otherwise critical trials.
Outlining the true potential of RWE made Dr. Wasiak’s article one of JCER’s top ten most widely read in 2020.
The article summarizes new and innovative uses of RWE to tackle challenges associated with sample size, historical data (or lack thereof), endpoint selection, and other features of advanced clinical trial design. The pandemic has refined both the technological resources and human resources to deploy studies more reliant on RWE.