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

 
• By Michael McCaughan

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.

FDA officials are eager to experiment with “master trial” protocols to allow simultaneous studies of multiple targeted oncology therapies as an alternative to traditional, single-agent registrational studies.

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
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Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
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Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
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A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

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Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
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