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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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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

More from R&D

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.