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Pazdur To Oncology Drug Developers: Step Back, Slow Down – And Find The Right Dose

 
• By Kate Rawson

FDA’s “Project Optimus” draft guidance on dose optimization is in the works. Until then, randomized dosing studies need to be an IND-level conversation.

Cancer cells on scientific background.3d illustration
Waiting to address dosing issues post approval will not be an option in the future. • Source: Shutterstock

 It may be time to start applying the brakes to oncology drug development.

Perhaps surprisingly, that’s the opinion of the US Food and Drug Administration’s Oncology Center of Excellence director Richard Pazdur. The...

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Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

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Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By Sue Sutter

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 
• By Anabel Costa-Ferreira

Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.

No ‘Doomsday’ For US Pharma Despite Political Uncertainties, EU Industry Chief Says

 
• By Eliza Slawther

While challenges in the US present an “incredible opportunity” for Europe, there is no “doomsday” happening there, Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says.