Netherlands To Require Information On Patient Involvement In Drug & Device Trials
Executive Summary
Sponsors of Dutch drug and device trials will have to describe in their study applications how patients were involved in drawing up and executing research plans or justify their non-involvement.
You may also be interested in...
EMA Confirms CTIS Ready For Mandatory Use By 31 January Deadline
The European Medicines Agency says that over 80% of the blocking issues and related workarounds affecting the Clinical Trials Information System have been resolved.
EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape
The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
Qualifying Digital Biomarkers ‘Much Easier Now’ Thanks To EMA Efforts
The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.