Randomized controlled trials will always be the backbone of drug development. But increasingly, sponsors need more than pre-approval efficacy data – they need proof that a treatment performs as expected once it reaches real patients, in real clinical settings, outside the controlled conditions of a traditional trial. That’s where Real-World

Evidence (RWE) studies come in, and it’s an area where American Research Center (ARC) has built dedicated capability.

What Real-World Evidence Actually Is

Real-World Evidence refers to clinical evidence about the usage, benefits, and risks of a medical product derived from analysis of Real World Data (RWD) – data collected outside the confines of a traditional randomized controlled trial. Sources of RWD typically include:

  • Electronic health records (EHRs)
  • Insurance claims and billing data
  • Patient registries• Prospective observational studies
  • Patient-reported outcomes

The FDA has increasingly recognized RWE as a valid tool – not a replacement for controlled trials, but a complement to them – particularly for supporting label expansions, post-market safety surveillance, and payer/reimbursement decisions.

Why Sponsors Are Investing More in RWE

A few forces are driving this shift:

Regulatory acceptance is growing. Since the 21st Century Cures Act directed the FDA to evaluate the use of RWE in regulatory decision making, the agency has issued a series of guidance documents clarifying how RWD/RWE can support both efficacy and safety claims in specific contexts.

Payers want proof beyond the trial. Health insurers and value-based care organizations increasingly want to see how a treatment performs across broader, more diverse patient populations before committing to coverage — something a tightly controlled Phase III trial population often can’t fully capture.

Post-market safety obligations. For many approved products, RWE studies are how sponsors fulfill post-marketing commitments and continue to monitor long-term safety signals.

Diverse, real-world populations matter. Traditional trials often enroll narrower patient populations than what a drug will encounter in practice. RWE studies help sponsors understand performance across comorbidities, age ranges, and demographics that a Phase III protocol may have excluded.

What an RWE Study Looks Like in Practice

Unlike an interventional trial, an RWE study typically doesn’t involve administering an investigational product under a strict protocol. Instead, it might involve:

  • Prospective observational tracking of patients already on an approved or standard-of-care treatment
  • Structured chart review and data abstraction from existing patient records
  • Patient registries following outcomes over time
  • Comparative effectiveness research against standard-of-care alternatives

This means RWE studies often demand different site capabilities than a traditional interventional trial — strong data infrastructure, experienced coordinators comfortable with longitudinal follow-up, and a patient population large and diverse enough to generate statistically meaningful results.

Why Chicago Is a Strong Fit for RWE Research

Chicago’s scale and demographic diversity are genuine advantages for RWE work specifically. A large, varied patient population across a major metro area gives sponsors access to the kind of real-world heterogeneity – in age, ethnicity, comorbidity profile, and care setting – that makes RWE data meaningful. Combined with a dense regional healthcare infrastructure, it’s a market that supports both the depth and diversity RWE studies depend on.

ARC’s Approach to Real-World Evidence Work

Real-World Evidence has become one of ARC’s core service lines alongside our Phase II and Phase III trial work. Our team applies the same regulatory discipline and patient-centered operational standards to RWE studies that we do to interventional trials – with the data infrastructure and longitudinal tracking capabilities RWE research requires.

Partnering With ARC on Your Next RWE Study

If you’re a sponsor or CRO exploring Real-World Evidence as part of a post-market strategy, label expansion effort, or payer engagement plan, we’d welcome the conversation.

Learn more about our services or reach out to our business development team at info@theamericanresearch.com.