US FDA’s Pazdur Suggests NCI Should Help Sponsors Enroll Clinical Trials For Innovative Drugs
Oncology sponsors would handle ex-US trial enrollment, but Pazdur feels tapping into the NCI network would improve trial speed and diversity. Biggest challenge will likely be generating sponsor enthusiasm for move that would involve giving up some control of development.
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US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
How Should The US Government Coordinate Emergency Clinical Trials?
Research institutions, CROs, biopharma industry and other stakeholders are asked to comment on potential governance structure that would determine when trials are needed to address disease outbreaks and other public health emergencies.
Political Trials On All Sides: Lilly CEO Laments Loss Of ‘Chamber of Commerce Republicans’
David Ricks says the challenging political environment is empowering regulators. The Lilly leader also talked Twitter and drug prices, in a STAT Summit interview.