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Guidance By Guidance, US FDA Is Reshaping The Look Of Cancer Drug Trials

 
• By Sue Sutter

Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is coming soon on master protocols, adaptive designs and novel endpoints, FDA's Gottlieb says.

Macro photo of tooth wheel mechanism with SUPPORT, ADVICE, HELP, GUIDANCE, ASSISTANCE and DIRECTION words imprinted on metal surface
US FDA is churning out a host of new guidance documents supporting the modernization of cancer drug trials.

The US FDA is using its guidance-writing powers to reshape the look of oncology clinical trials, with the goal of streamlining and modernizing cancer drug development in order to foster a more patient-focused approach.

In the past three months, the agency has issued draft guidance documents aimed at expanding the ages of cancer patients...

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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

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

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The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

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UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By Vibha Sharma

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
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Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

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