Project Pragmatica: US FDA’s OCE Initiative Aims To Encourage Simple Clinical Trials
OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.
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Fully Enrolled Confirmatory Studies Can De-Risk Novel Accelerated Approval Endpoints – FDA Official
Oncology Center of Excellence Deputy Director Paul Kluetz talks about what might make a drug a good candidate for a Project Frontrunner-type development program and how sponsors might benefit from FDA’s experience with OCE’s first Project Pragmatica pilot.
US FDA Exploring Consortium To Develop Treatments For ‘Economically Infeasible’ Cancer Indications
The FDA could partner with industry, academia and advocacy groups to speed development of novel treatments for cancers that are not commercially viable.
FDA’s Califf Calls For Return To Large, Simple Trials Without The ‘Useless Stuff’ That Slows Development
US FDA Commissioner Califf praises both Project Pragmatica and the ‘very powerful’ partnership between OCE Director Rick Pazdur and National Cancer Institute Director Monica Bertagnolli.