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Beyond Phase I: Expansion Cohort Trials Bring Efficiencies, Regulatory Challenges

 
• By Sue Sutter

First-in-human, expansion cohort trials are on the rise in oncology, but protocols for such studies can be highly problematic, lacking clear objectives, well-defined populations and independent oversight.

Sponsors seeking to conduct Phase I expansion cohort studies must be prepared to address numerous design, statistical and ethical hurdles inherent in such an approach so that the data can be used to support product registration, a multi-stakeholder group said at a cancer research policy conference Nov. 17.

Traditional clinical trial phases in oncology development are increasingly becoming blurred, leading to more first-in-human trials that are subsequently expanded...

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More from United States

US FDA Maintaining Approval Output Despite Losing Staff

 
• By Derrick Gingery

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Lilly’s Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit

 
• By Cathy Kelly

Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.

Cancer Drug Combos: US FDA Guidance Offers Options Beyond Factorial Trials

 
• By Manas Mishra

Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

US FDA Rare Disease Hub RISEs After Slow Start

 
• By Michael McCaughan

The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.

More from North America

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.