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White Paper
Natural History Studies for Rare Diseases
Development strategies for external comparator arms leveraging real world insights
Sep 30, 2020
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  • Natural History Studies for Rare Diseases

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Natural history studies have historically been used by clinical researchers to understand disease progression in poorly characterized diseases. More recently, these studies have been re-purposed in a variety of ways to facilitate clinical development in rare disease. These include serving as external comparators to support rare disease treatment approvals when it is unethical or unfeasible to evaluate the treatment with a randomized controlled design.

When these real-world, protocol-driven studies are integrated into the early clinical development planning process, they can accelerate drug development, improve the odds of regulatory approval and reimbursement, and bring new life-changing treatments to patients in need.

This white paper explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.

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