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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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ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
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A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.