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FDA Eager For More Master Protocols in Oncology: Approach Means Lower Cost For Sponsors—and Less Control

This article was originally published in RPM Report

Executive Summary

FDA officials are enthusiastic about broad, multi-agent cancer trials built on the I-SPY model. For sponsors, the trials mean less control over the development path and ultimate value proposition for the therapy—but may have important benefits on defending high prices for truly effective new therapies.

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