Real-World Evidence for Modern Development
Traditional randomized controlled trials remain essential for drug development, but they have important limitations that real-world data (RWD) can help address.
Limitations of Traditional Randomized Clinical Trials (RCTs)
- Patients with comorbidities, concomitant medications, or complex clinical histories are often excluded, limiting representation of routine-care populations.
- Medications are evaluated under protocol-defined conditions that may not fully reflect real-life treatment use patterns.
- Clinical development remains time-consuming and costly, while success rates continue to be challenging.
How RWD Complements RCTs
RWD generated from routine clinical care can complement traditional clinical trials by providing:
- Broader patient representation across comorbidity profiles and clinical subgroups
- Real-life treatment patterns and clinical decision-making
- Longitudinal outcome information across multiple lines of therapy