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QURE Clinical Utility

Reduce the time and cost of obtaining clinical utility data to obtain coverage and reimbursement with private and public payers.

Business Solutions

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The Quicker, More Efficient Path to Clinical Utility Evidence

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.

Simulated Clinical Trials

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.

Key Benefits

  • Generates clinical utility data that you can provide to private and public payers
  • Identifies the need for new product and/or educational intervention
  • Links behavior change and intervention impact directly to patient outcomes
  • Reduces time and effort to perform patient recruitment
  • Reveals or affirms unmet needs in the care pathway

Settings Where Simulated Patients Are Especially Well Received by Payers

Challenging to gather enough patients

Reduces harm linked to current practice

Product already linked to better outcomes

Long-term outcomes too distant or catastrophic to miss

Scientific Papers on Utilizing Virtual Patients to Establish Clinical Utility

How it Works

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

QURE data resulted in two high-quality, peer-reviewed publications demonstrating the clinical utility of our FirstStepDX genetic test."
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Michael Paul