Regulatory and Reimbursement Success with External Comparators

Regulatory and reimbursement success with external comparators

Augment your clinical studies with a control arm from real world data to add comparative context. Generate impactful evidence to support successful market authorization and reimbursement.

External comparators: what, where, and how to use

What is an external comparator?

An external comparator or control (sometimes called a synthetic control) is aggregated, real world data (RWD) from patients that are similar to your clinical trial population.

Where are external comparators sourced from?

We identify trial-like patients in our RWD sources based on your trial’s eligibility criteria and capture outcomes on those patients that align with the clinical trial protocol.

How can you apply external comparators?

Your researchers can use an external comparator to understand how trial-like patients progress without exposure to the interventional product from your trial. Comparisons can be made between the treated and untreated populations to understand how well your investigational product works. This evidence can be used to enhance your submissions to regulators and payers.

Resolving the evidence gap for single-arm trials

Trials designed as single-arm, or uncontrolled, have comparative evidence gaps that can be bridged with external controls or comparators. An analysis of IQVIA’s Health Technology Assessment Accelerator indicates that submissions relying on a pivotal single-arm clinical trial are more likely to receive a positive HTA decision if an external control or comparator from RWD is also included in the submission.

External comparators powered by the IQVIA CORE

  • Deep Patient-Level Data – Through one of the world’s largest curated healthcare data sources, we can help find highly target patients to match your trial population across the globe.
  • Scientific Leadership – Our disease experts, epidemiologists, and regulatory scientists can help you successfully engage regulators and payors to design the right external comparator for your study.
  • Extensive Research Expertise – Leverage our acquisition, integration, and analysis of diverse clinical and RWD sources to generate compelling evidence and accomplish your research objectives.
  • Transformative Technology – Get the data you need in the most efficient way possible while adhering to global regulations and data privacy standards.
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