What is an evidence-generation program?
An evidence-generation program is a strategic framework used to plan, develop, and deliver data that demonstrates the clinical effectiveness, safety, economic value, and real-world impact of a pharmaceutical product. It includes both pre- and post-launch activities and may involve clinical trials, real-world evidence (RWE) studies, observational research, health economics and outcomes research (HEOR), and patient-reported outcomes (PROs). Programs are typically tailored to the needs of key stakeholders such as regulators, payers, providers, and patients.
Why are evidence-generation programs important?
Evidence-generation programs enable pharmaceutical companies to build a comprehensive value story, address stakeholder evidence requirements, and support market access and reimbursement. By generating relevant and credible data throughout the product lifecycle, companies can inform clinical decision-making, enhance competitive positioning, and meet evolving expectations for transparency, patient-centered outcomes, and long-term impact.
