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https://pharmaceutical.report/Resources/Whitepapers/9d8a8e46-5aee-46c5-93c8-89cc7fb0eae0_Comparative Tolerability Whitepaper_FINAL.pdf
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BROADENING THE DEFINITION OF TOLERABILITY IN CANCER CLINICAL TRIALS TO BETTER MEASURE THE PATIENT EXPERIENCE
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Robust safety and tolerability data are essential in cancer therapeutic studies, and some trials are specifically designed with a key objective of demonstrating improved safety and tolerability. The development of a clinical trial framework and data elements to demonstrate comparative safety and tolerability requires a suite of endpoints and approaches to enable meaningful interpretation of results for regulatory and clinical decision-making.
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