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‘Resilient’ Trials: US FDA Wants To Apply COVID Lessons In Trial Design

 
• By Michael McCaughan

The US FDA is not expecting sponsors to launch ‘pandemic-proof’ trials, but does want to see advance planning so that adaptations can be implemented for unexpected emergencies with ‘less burnout.’

resilient clinical trials
• Source: Shutterstock

The US Food & Drug Administration wants clinical trial designs to anticipate potential changes that might be necessary in the event of a public health emergency or natural disaster.

During an October workshop on mitigating clinical trial disruptions, Center for Biologics Evaluation & Research Deputy Director Celia Witten captured a key message from the discussion: “The goal is not to ensure that every

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• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

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• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

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Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By Marion Webb

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

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SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By Marion Webb

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.

LSX Europe: Women’s Health Education Is The Key For Unlocking VC Investment

 
• By Natasha Barrow

Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.