Using real-world data to optimize your next oncology protocol
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Oncology clinical trials are critical to advancing cancer treatment, yet they are often complex, costly, and prone to delays. To address these challenges, leveraging real-world data (RWD) at the protocol design stage offers significant opportunities for improvement. This playbook explores how high-quality RWD can be used to optimize clinical trial protocols, enhancing study feasibility, patient recruitment, and site selection while reducing the likelihood of costly amendments.
Drawing on regulatory guidance and recent research, this playbook outlines a four-step process for incorporating RWD into trial planning, from initial study design to broader portfolio adoption. Case studies highlight the positive impact of RWD on patient diversity and trial efficiency, providing a practical guide for biopharma companies to set their oncology trials up for operational and scientific success.
