In a multilateral paradigm shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late-phase (RWLP) trials. The increasing use of real-world data (RWD) and real-world evidence (RWE) to support clinical development has been informed by recent regulatory guidance and accelerated by the global COVID-19 pandemic. Stakeholders across the spectrum are demanding evidence of the benefits of treatment interventions. According to “The State of the Biopharmaceutical Industry 2021,” a survey by GlobalData, RWE ranks fourth among the top trends in the industry.{1} Verified Market Research estimates that the global RWE market will reach $1.9 billion by 2026.{2}
Data from RWLP studies are invaluable in bridging the gap from drug efficacy to effectiveness and from development to commercialization. As pricing and market access pressures mount and the cost of drug development rises, the use of RWE in research and development has become a strategic focus for sponsors and regulators alike. Increasingly, RWE is being used to support regulatory filings and augment traditional randomized controlled trials.