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UK Explains How To Plan For Randomized Trials Using Mainly RWD Sources

Guideline Does Not Cover Clinical Trials Using RWD As A Control Arm

 
• By Vibha Sharma

The UK Medicines and Healthcare products Regulatory Agency has finalized the first part of a series of new guidance documents addressing issues around using real-world data in support of regulatory submissions. 

Electronic health record or EHR on tablet show personal health information
Use of RWD can make clinical trials more cost-effective • Source: Alamy

The UK medicines regulator has finalized much-awaited guidance explaining how drug sponsors can conduct randomized controlled trials (RCT) primarily using real-world data (RWD) sources to support a regulatory decision relating to a medicinal product. 

Its use could make it more feasible for sponsors to repurpose their existing medicines for new conditions and help bring life-changing new medicines more quickly to those who need them,

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German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
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