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The Future of all-Comers Trials in the Era of Precision Oncology
J Andrew Williams1, Nitin Jain2, Caroline MacNish Porter1
1Precision Diagnostics Development, AstraZeneca R&D, Cambridge, UK.
Abstract:
Approvals of new therapeutics are increasingly restricted to specified biomarker subgroups, even where pivotal clinical studies meet primary endpoints in broader "all-comers" populations. In this article, we discuss the potential factors that increase the likelihood of approvals in biomarker subpopulations rather than all-comers. We outline mitigation strategies drug developers can pursue to plan for potential label restrictions and achieve companion diagnostic readiness, ensuring patients receive timely access to innovative medicines.
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