1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

Lung Cancer “Master Protocol” Eyed As Paradigm-Changing Approach To Drug Development

 
• By Sue Sutter

The biomarker-driven, multi-arm, multi-drug registration trial is expected to get under way in March 2014 with five drugs from different sponsors. With the promise of greater speed and efficiency in patient enrollment and late-stage development, it is being viewed as a potential model for other cancer settings.

A first-of-its-kind “master protocol” for a Phase II/III registration trial in lung cancer not only could lead to new treatments for advanced squamous cell disease, it could fundamentally change the clinical development paradigm for new oncologics in the U.S. and elsewhere.

Governmental entities, research and advocacy communities, and the pharmaceutical and device industries have come together through a public-private partnership to...

Welcome to Pink Sheet

Create an account to read this article

Already a subscriber?

More from United States

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion

 
• By Sue Sutter

The CDC’s current shared clinical decision-making recommendation for vaccinating healthy children age six months and older should trigger full coverage under the Affordable Care Act, but is not always happening at pharmacies and doctors’ offices, an Epstein Becker attorney said.

US FDA Suspends Valneva’s Ixchiq Based On Four New Serious AE Reports

 
• By Sue Sutter

After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By Grace Moser

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

More from North America

US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

 
• By Laura Helbling

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.

Medicare Part D Plans Turn to Coinsurance, Higher Deductibles Amid IRA Changes

 
• By Tim Casey

Newly implemented IRA provisions may not necessarily lower drug costs for those enrolled in Medicare Part D plans, according to research by the USC Schaeffer Center for Health Policy and Economics.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.