What is an evidence hierarchy?
An evidence hierarchy categorizes sources of clinical and scientific information according to their strength and credibility. At the top are systematic reviews and randomized controlled trials (RCTs), followed by observational studies, expert opinion, and anecdotal reports. This hierarchy is commonly used by regulatory bodies, payers, and guideline developers to assess evidence quality.
Why is the evidence hierarchy important in pharmaceutical development and market access?
Understanding and aligning with the evidence hierarchy is essential for demonstrating clinical value, passing HTA reviews, and securing favorable payer decisions. It informs evidence-generation planning and ensures that the right types of data are prioritized to meet stakeholder expectations across regulatory, clinical, and economic domains.
