Project Optimus, initiated by the FDA, seeks to transform early cancer research by focusing on optimized doses and reducing toxicity in blood cancer drugs. The strategy involves moving away from the traditional maximum tolerated dose approach and implementing randomized, parallel dose-response trials. This shift is crucial due to the significant adverse effects that blood cancer drugs can cause, emphasizing the importance of controlling toxicity in hematology research. The FDA's goal is to balance the maximum tolerated dose with a safe and tolerable dose for most patients, aiming to minimize toxic side effects in drug development. However, this transition may lead to increased costs and challenges for smaller companies in funding clinical trials, potentially impacting the number of investigational drugs in the future.
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by Randy Doting... at www.medscape.com 11-15-2023
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