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Cancer Drug Dose Optimization Benefits Include Better Pivotal Trial Retention, Fewer Clinical Holds

 
• By Sue Sutter

US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.

Quick sand
Basing a drug development program on a shaky dose is like building a house on quicksand, OCE director Richard Pazdur says. • Source: Alamy

The significant advantages of conducting more extensive dose-optimization studies early in oncology drug development will overcome industry and patient concerns about perceived delays in bringing new therapeutics to market, representatives from the US Food and Drug Administration, industry and patient community said.

At the Friends of Cancer Research annual meeting last month, a multi-stakeholder panel discussed the FDA Oncology Center of Excellence’s Project Optimus initiative, the agency’s call for cancer drug developers to conduct randomized, dose-optimization studies

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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
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Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.