1. Pink Sheet
  2. >>Geography

Remote Decentralized Clinical Trials Could Solve RCT Problems

IMI Project Aims To Establish New Paradigm For Clinical Trials

 
• By Francesca Bruce

A new project by Europe’s Innovative Medicines Initiative that is comparing decentralized and traditional clinical trials was launched just before Janssen announced its own decentralized trial.

Render illustration of Clinical Trial title on medical documents
A new IMI Project Aims To Find A new Way Of Doing Clinical Trials

Europe’s Innovative Medicines Initiative has launched a new project, Trials@Home, to evaluate how remote decentralized clinical trials (RDCTs), which use new technologies to allow bigger, more diverse and remote populations to take part in clinical trials, could become the gold standard for clinical research. The project’s coordinator, Diederick Grobbee, explained to the Pink Sheet how RDCTs may replace traditional randomized control trials (RCTs).

The launch of the project came just before Janssen Pharmaceutical Cos. announced on 16 November its own decentralized trial...

More from Europe

More from Geography

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

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.