Decentralized Clinical Trials: Quantifying Costs, Benefits Could Drive Adoption, Reduce Disruption
Routine inclusion of approaches such as local assessments and remote monitoring could reduce patient burden and avoid protocol deviations, but industry needs to see a return on investment, in the form of easier recruitment, better diversity and/or faster studies, experts said.
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Despite encouragement from regulators, quality-by-design and risk-based monitoring approaches for clinical trials have not been fully adopted. Experts say careful, cross-disciplinary thinking is needed in the study design phase, along with adoption of the quality mentality seen on the manufacturing side.
AI initiatives in a country known for its software prowess, along with startup support, clinical trial rule changes, crunched approval timelines, unified digital regulatory interfaces and a R&D policy laying out $600m in funds, are all meant to build something greater than the sum of its parts. In a bottom-up approach, India is building an innovation ecosystem
The US FDA is not expecting sponsors to launch ‘pandemic-proof’ trials, but does want to see advance planning so that adaptations can be implemented for unexpected emergencies with ‘less burnout.’