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"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

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Harness the power to transform clinical development

Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.

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Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.

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The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

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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 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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