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Overall Survival Data Collection Can Help Mitigate Bias In Open-Label Studies, US FDA Says

 
• By Sue Sutter

FDA oncology review staff discuss cases studies involving Amgen’s Lumakras and Novartis’ Pluvicto, where there was a perceived loss of equipoise, and how mitigation strategies helped save the latter’s pivotal trial.

Crystal ball
Oncology sponsors need to plan ahead for ways to mitigate bias resulting from a potential loss of equipoise. • Source: Shutterstock

Pre-planned, long-term collection of overall survival data for patients who withdraw from a clinical trial may be able to “save” an open-label study tainted by systemic bias resulting from a potential loss of equipoise, US Food and Drug Administration oncology officials said.

Patient and investigator education, blinded independent central review (BICR) assessments in real time, allowance for crossover, and capping enrollment at sites with high dropout rates can help mitigate bias in...

Key Takeaways

  • Given the new paradigm of precision oncology, the potential loss of equipoise is likely going to be a recurrent issue, especially if a control arm is...

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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.

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.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

More from R&D

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.