Real-World Evidence Conference

Real-world data (RWD) and real-world evidence (RWE) often find their place in clinical development toward its conclusion. Results derived from them are often reserved for medical affairs, market access, or to bolster existing pre-planned clinical trials. However, this approach can create significant challenges, hindering the potential utility of RWE due to trial designs and protocols that may not align well with generating fit-for-purpose RWD. Today, there is growing momentum from regulators and scientists to shift towards a systematic integration of RWE during the initial trial design phase.

This presentation sheds light on the barriers that traditionally separate randomized clinical trials (RCTs) and RWE, highlighting the need for a more blended approach. Emerging concepts such as externally controlled trials and innovative designs like cohort multiple randomized controlled trials or trials within-cohorts are gaining traction as effective means to capture novel patient insights. By exploring the convergence of these diverse methodologies, we can uncover more meaningful and comprehensive insights than what each can achieve independently.