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PROGRAM OBJECTIVE

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Understand how real-world evidence can be used effectively in a regulatory environment.

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THE CHALLENGE

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The cost of developing new drugs and approving new indications for existing drugs continues to be high, leading to high drug prices.

Randomized clinical trials (RCTs) are the "gold standard" to ensure drug safety and efficacy. RCTs are also time-consuming, complex and costly. Recent legislation (Prescription Drug User Fee Act VI and the 21st Century Cures Act) mandates investigation into new ways to generate evidence.

Real-world data (RWD) from claims and electronic health records can provide evidence to complement what is learned in RCTs and enable innovation in clinical trial design. It is important to understand the utility and limitations of this data to use it responsibly.

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OUR ROLE

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OptumLabs, in collaboration with the MRCT Center, is co-leading Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) to examine the principles, methodologies and use of real-world data in regulatory review and approvals of medical treatments.

OPERAND convenes diverse experts from industry, academia, government and others to advise, oversee and replicate clinical trials with deidentified clinical and administrative claims data from the OptumLabs Data Warehouse.

The program will replicate two RCTs: ROCKET for atrial fibrillation and LEAD-2 diabetes control. Our goal is to test different methods to inform standards for how to reliably generate evidence for new drug indications and safety surveillance of existing drugs.

Understanding how data, statistical methods and researcher decisions influence observational study results is key to enabling innovation in the use of real-world evidence for regulatory decision-making.

– William Crown, Chief Scientific Officer, OptumLabs
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COLLABORATORS

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Project co-leads

  • OptumLabs  
  • The Multiregional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center)
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Sponsors

  • Amgen
  • AstraZeneca
  • Merck
  • Optum
  • Pfizer
  • Sanofi
  • UCB BioSciences, Inc.
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Research collaborators

  • Brown University
  • Harvard Pilgrim Health Care Institute
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Expert advisory panel

  • Andre Araujo, PhD, Eli Lilly & Company
  • Dorothee B. Bartels, PhD
  • Sandeep Burugupalli, MPH, Pfizer
  • Cathy Critchlow, PhD, Amgen
  • Greg Daniel, PhD, MPH, RPh, Duke-Margolis Center for Health Policy
  • David Dore, PharmD, PhD, Optum Analytics 
  • Jennifer Graff, PharmD, National Pharmaceutical Council 
  • John Graham, PharmD, GlaxoSmithKline 
  • Solomon Iyasu, MD, MPH, Merck
  • Javier Jimenez, MD, MPH, Sanofi
  • Linda Kalilani, PhD, MPhil, UCB BioSciences, Inc
  • Sajan Khosla, PhD, AstraZeneca
  • Robert LoCasale, PhD, MS, Sanofi
  • David Martin, MD, Food and Drug Administration (ex officio)  
  • Patricia Russo, PhD, Novartis
  • Richard Willke, PhD, ISPOR