Clinical Trials
Medical device sponsors can use real-world evidence without submitting identifiable patient-level data under a new guidance that is expected to expand to drugs and biologics.
The UK’s roadmap for reducing animal testing is a positive starting point, but greater transparency from the drug regulator and a more detailed workplan from government will be required to make the plans a reality, an expert from Cruelty Free International says.
The EU’s draft Biotech Act promises faster clinical trial approvals and innovation incentives, but the industry warns that intellectual property provisions have limited appeal.
A Friends of Cancer Research working group believes “seamless” trial designs could be used more frequently for rare cancer drug development, but advanced planning is key.