The RWE Problem Isn't Quality. It's Communication.

The quality of manufacturer-generated real-world evidence is rarely the problem. According to Cate Lockhart, PharmD, PhD, AMCP's chief science officer, pharmaceutical companies routinely invest significant resources to meet rigorous internal compliance and quality standards before a single study reaches a payer audience.¹ The breakdown, she argues, happens after the science is done, in how the evidence is packaged, framed, and communicated to decision-makers who often lack the experience to evaluate it.

Lockhart leads AMCP's Real-World Evidence Initiative, a multistakeholder effort to bridge the gap between manufacturers and payers.² In this second installment of her conversation with Pharmaceutical Commerce, she turns to what credible, decision-ready RWE actually looks like from the payer's perspective — and why closing that gap requires a shared language as much as it requires better data.

Central to that effort are AMCP's newly published RWE Standards, which address the problem from both directions.¹ For manufacturers, the standards function as a roadmap, guiding how evidence should be presented so it maps directly to payer decision-making frameworks. For payers, who have historically had far less experience evaluating observational research than clinical trial data, the standards include a payer-focused checklist specifying what to look for when assessing a study.³ The framework also expands the definition of relevant RWE beyond post-marketing safety and effectiveness, recognizing that different evidence types carry value at every stage of a product's life cycle, from pre-approval through long-term outcomes tracking.¹

Lockhart calls the standards a "translation tool." In this installment, she explains what that means in practice.

Access the first part of Lockhart’s interview with PC:

1. Payers Want Real-World Evidence. Why Aren't They Using It?

References

1. Lockhart CM, et al. AMCP real-world evidence standards: Overcoming barriers to using real-world evidence in US payer decision-making. J Manag Care Spec Pharm. 2025;31(12):1230-1236. Published online June 27, 2025. Accessed June 23, 2026. https://www.jmcp.org/doi/10.18553/jmcp.2025.25108
2. Academy of Managed Care Pharmacy. Real-World Evidence (RWE) Initiative. AMCP.org. Accessed June 23, 2026. https://www.amcp.org/RWE
3. Academy of Managed Care Pharmacy. AMCP Real-world Evidence Standards to Support Payer Decision-Making. AMCP.org. Accessed June 23, 2026. https://www.amcp.org/resource/amcp-real-world-evidence-standards-support-payer-decision-making