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Using real-world data to optimize your next oncology trial protocol

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"Using real-world data to optimize your next oncology trial protocol"

Set your trial up for operational and scientific success

Clinical trials serve as the linchpin in bringing innovative cancer treatments to market. However, modern trials can be complex, expensive, prone to delays, and their success is far from guaranteed.[1] Thankfully, trial sponsors and contract research organizations (CROs) can now draw on high-quality real-world data (RWD) at the protocol design stage — with encouragement and formal guidance from regulatory agencies like the FDA[2] — to anticipate potential problems and address them before they become costly and time consuming.

In this playbook, clinical research experts from Bristol Myers Squibb and Flatiron Health unpack the current challenges facing clinical trials and provide a four-step guide to help the various roles involved in clinical trial design maximize the impact of RWD on future trials.

This paper also covers:

  • Data on RWD’s current usage
  • Case studies demonstrating the real impact of RWD on protocol design
  • Steps to maximize use of RWD in your organization

 

[1] Only 3.4% of oncology trials go successfully from phase I to approval, and barely more than a third from phase III, by far the lowest among major therapeutic areas. Estimated R&D investment needed to bring a new medicine to market, 2009-2018. JAMA (2020)

[2] Real-world evidence — where are we now? NEJM (2022)


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