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Sepsis Pipeline Could Be Resuscitated With Narrower Trials, Researchers Propose

 
• By Bridget Silverman

Sepsis trials designed with narrower enrollment criteria could allow treatment effects to emerge, countering the “signal to noise” problem that has plagued late-stage trials in sepsis, researchers suggest.

Sepsis has long been the Bermuda Triangle of pharma R&D, responsible for a litany of clinical failures for three decades. But researchers from UCLA and Massachusetts General Hospital East are proposing that narrowing the focus of clinical trials could allow treatment effects to become clearer -- and foster a still-nascent pipeline of new approaches to what could be a very large market for the often-fatal systemic response to infection, a common condition in critical care medicine.

Despite positive signs in preclinical and early clinical studies, demonstrating improved survival has been an insurmountable hurdle for sepsis candidates....

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More from Clinical Trials

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from R&D

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.