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

ODAC Backs Random Sample Audits Of Progression Events

 
• By Sue Sutter

FDA’s Oncologic Drugs Advisory Committee supports easing the current requirement for blinded, independent central review of 100% of patient scans in studies using progression-free survival as the primary endpoint. However, committee members say FDA needs the flexibility to require full case audits in certain circumstances, depending upon tumor type and study size.

Independent review of study investigators’ progression assessments in only a subgroup of patients is a feasible strategy for oncology trials, but may not be appropriate in all cases, FDA’s Oncologic Drugs Advisory Committee said July 24.

While ODAC members endorsed the concept of auditing only a random subgroup of patients’ scans, they said 100% review may still be necessary for small studies and trials in which...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos for Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

The US Medicare Patient Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

More from North America

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
• By Derrick Gingery

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.