Real-world evidence for medical affairs: who can actually use it?

USE CASE
Real-World Evidence & Scientific Communication Intelligence 

Real-World Evidence (RWE) has moved from a regulatory novelty to an expectation. Payers increasingly require RWE to support formulary placement. Regulators are accepting RWE for label expansions and post-approval commitments as part of the FDA's Real-World Evidence Framework, established under the 21st Century Cures Act. Physicians want outcome data from patients like their own. The appetite for evidence generated outside the controlled trial environment has never been higher.

So what’s the difference between Real-World Data (RWD) and Real-World Evidence (RWE)?

• RWD is health information collected outside the controlled clinical trial setting and drawn from the routine delivery of care. Common sources include electronic health records (EHRs), administrative and insurance claims, patient registries, wearables and digital health devices, pharmacy dispensing records, and patient-reported outcomes.
• RWE is what emerges when that data is analyzed with scientific rigor: the clinical and economic insights about how treatments perform in actual patient populations.

The distinction matters because RWD is abundant but raw; RWE requires study design, analytical methodology, and interpretive discipline to be credible.

The challenge for Medical Affairs leaders isn't access to real-world data. Most large pharmaceutical companies have invested substantially in RWE data assets: claims databases, EHR data partnerships, patient registries. The challenge is the scientific and operational fluency to generate, interpret, and communicate insights from those assets quickly enough to be relevant in competitive and regulatory timelines.

The Four Commercial Use Cases for RWE in Medical Affairs

Medical Affairs teams are being asked to deploy RWE across four distinct commercial conversations, each with different audiences, timelines, and evidentiary standards.

• In regulatory contexts, RWE supports label expansion submissions and satisfies post-approval commitments, evidence generated from real patient populations that complements or extends what controlled trials established.
• For payer audiences, formulary placement increasingly depends on demonstrating outcomes in populations that mirror a health plan's own members, not idealized trial enrollees; a medical director wants to see persistence, adherence, and total cost of care data from patients who look like their own.
• In HCP scientific exchange, field medical teams need rapid access to subgroup and outcomes data that speaks to the specific patient profiles physicians treat in their practice, questions that arise in the room, not six weeks later.
• And internally, pipeline and portfolio decisions benefit from RWE signal: understanding how a new asset performs against existing treatment patterns in the real world informs development prioritization and lifecycle management before a Phase III readout can.

Why Real-World Evidence Analysis Lages Behind the Data

A VP of Medical Affairs managing multiple therapeutic areas needs to answer complex scientific questions: How are patients in the real world performing on our treatment compared to what was observed in the clinical trial? What subpopulations are showing differential benefit? These questions require sophisticated data analysis, and they're being asked more frequently than most Medical Affairs data teams can service.

A payer medical director asking about real-world outcomes in their patient population doesn't want to wait six weeks for a custom analysis. They want to have that conversation now.

Genie for Real-World Evidence Analysis

Databricks Genie enables Medical Affairs leaders to interrogate their RWE data assets in natural language. A VP of Medical Affairs can ask: 'In our claims database, what's the proportion of patients initiating therapy who were previously treated with our product versus treatment-naive, and how does their 12-month persistence compare?' That question, which would have required a data scientist several days to answer, surfaces in seconds.

Real-World Evidence in Payer and Regulatory Conversations

The life sciences companies that will win the RWE era are the ones whose Medical Affairs teams can generate and communicate evidence with scientific credibility and commercial speed. Genie removes the data access bottleneck that slows the evidence generation process. In a market where scientific conversations are increasingly evidence-driven, that speed advantage is real.

DATABRICKS GENIE · KEY DIFFERENTIATORS
Built for your data, governed by your rules, answerable to any business leader.

• RWE data asset integration: Claims, EHR, registry, and lab data in a unified environment — no system-switching for multi-source analyses.
• Scientific governance: Genie operates within your data use agreement and scientific review framework — analysis requests are logged and attributable.
• Indication and treatment pathway awareness: Genie understands your therapeutic area's treatment landscape in the context of your data assets.
• MSL support: Field Medical teams can access appropriate RWE insights to support scientific exchange conversations with HCPs — with appropriate access controls.

See What Genie Can Do for Your Team

Databricks Genie is available today. See how your industry peers are using it to reimagine how they access and act on their data.