Remote Decentralized Clinical Trials Could Solve RCT Problems
IMI Project Aims To Establish New Paradigm For Clinical Trials
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.
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The COVID-19 pandemic has given a fresh impetus to the ongoing EU project on remote decentralized trials with more appetite for innovative approaches.
European payers and health technology appraisal organizations have warned that their decision making is being increasingly hampered by evidence gaps. Some solutions may lie in the better use of existing mechanisms, such as scientific advice and managed entry agreements, while others could be introduced through the overhaul of the EU pharmaceutical legislation.
The difficulties in getting advanced therapies, such as Novartis’ CAR T therapy Kymriah, to patients have shifted and manufacturing capacity is no longer the biggest issue.