Real World Evidence

Real-World Evidence Synthesis, Study Design, and Database Analysis

Real-world evidence is used to address information gaps throughout the product lifecycle, from development through launch and commercial growth into the mature stage; real-world evidence can address research questions that are difficult to answer using data from a randomized controlled trial, such as long-term clinical effectiveness and safety, prescribing patterns, patient-centered outcomes, and cost impact. External influencers and modifiers like price reviews, reimbursement assessments, new competition, generic market entries, and new indications require a nimble and proactive RWE approach to continue commercial success. Evidence needs are increasingly more demanding and cover a wide range of topics:

• Differentiation in sub-populations
• Target populations
• Usage difference
• Effect of switching on outcomes
• Differentiation vs. generic
• Post-launch commitments to regulatory authorities

The impact of real-world evidence is becoming tangible across the spectrum of stakeholders:
 

• Regulators use real-world evidence to inform label expansion decisions and for post-market safety surveillance.
• Payers have used real-world evidence to inform pricing assessments when making reimbursement decisions.
• Manufacturers use real-world evidence to provide scientific insight on the effectiveness and safety.
• Physicians may increase their use of a product based on real-world evidence.