Patient Registries: Disease, Safety, Product, Service, and Quality

Our unmatched experience and expertise in patient registries makes us the unequivocal leader in designing and implementing these programs.

Writing the Book on Registries
In 2007, the AHRQ published “Registries for Evaluating Patient Outcomes: A User’s Guide.” Outcome’s Drs. Richard Gliklich and Nancy Dreyer were the principal investigators and senior editors of this landmark federal initiative.

Clinical Trial or Patient Registry?

Although randomized phase I-III clinical trials provide important data, they generally study carefully selected groups of patients under controlled conditions. Physicians, payers, and patients all want evidence of the results of medical products, therapies, and services in larger and more diverse populations and in situations that represent real-world conditions. In a world of limited resources and patients with a myriad of risk factors and health conditions, stakeholders need to determine which products and services are safer and more effective under a variety of real-world scenarios and in the populations that they serve.

Real-World Evidence

Patient registries, whether disease-based or product-focused, can provide your organization, as well as the health community, with invaluable data about the natural history of a disease under standard care practices and/or the safety and effectiveness of a product. These data can then be presented as evidence to:

• Meet safety requirements and manage benefits and risks
• Provide evidence to meet evolving coverage or reimbursement requirements
• Generate scientific evidence and publications
• Develop Treatment Guidelines
• Demonstrate good product stewardship

What do you want from your patient registry?

• Generate knowledge and evidence (scientific presentations and publications)
• Demonstrate effectiveness or comparative effectiveness in different populations
• Meet post-marketing commitments
• Generate evidence for coverage
• Monitor safety
• Manage risks and benefits
• Generate data for new indications or label extensions
• Change behavior
• Improve quality of care
• Prove product value through economic or quality of life benefits
• Bring scientific information to stakeholders sooner
• Enhance the practice of personalized medicine

You may choose to initiate a patient registry for many reasons: scientific, commercial, or regulatory. One fact holds true for all registries – they are very different from clinical trials in terms of design, logistics, approvals, sites, and site expectations; therefore, success demands different expertise and core competencies.

Whatever drives your patient registry, Outcome can provide all the services needed to design, implement, and manage a high-quality study. We lead the way in patient registries because of our unmatched experience, value, and feature-rich technology, our focus on customer service, and our unique partnerships.