QURE Clinical Utility

Gaining access to real-world clinical practice data can take months, if not years, and often millions of dollars to acquire. Whether you’re evaluating new diagnostic tests, new therapeutic options, or new educational tools, QURE’s randomized patient simulations provide evidence of clinical utility and accelerate market access at a fraction of the time and cost. We ensure you generate robust clinical utility evidence to aid coverage and reimbursement efforts.

QURE’s simulated patient cases have been scientifically validated to elicit real-world clinical practice patterns from providers. This offers a novel, inexpensive way to reveal whether an intervention (therapeutic agent, diagnostic test, etc.) provides clinical utility. QURE can do this in a more cost-effective way than enrolling live patients in randomized controlled trials. Simulations meet all standards set by the Center for Medical Technology Policy on clinical utility.

The randomized controlled trials take place in two rounds. Round one demonstrates the existing variability and practice gaps in diagnosis and treatment of the condition of interest. Round two demonstrates the difference in diagnosis and/or treatment for intervention arm(s) given access to new life-science products. QURE publishes two peer-reviewed papers clarifying the unmet need and the clinical utility/benefit that can be achieved to provide coverage and reimbursement and/or comparative effectiveness research (CER).

RCTs Answer 3 Key Questions

1. What Are the Gaps in Care?

• In practice
• In innovative care
• In the use of products

2. How Do We Measure and Improve the Utilization of the Product?

• Introduce the product to an intervention group(s)

3. Do We Have What Need to Prepare for Regulatory and Coverage?

• Statistically significant improvement, garnered from high-quality data collection
• Results have to stand up to peer-review