Risk-Based Monitoring: US FDA Clarity And Industry Standards Aren't Enough
Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.
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Recent Q&A draft guidance is aimed at assisting sponsors in planning and conducting risk-based approaches to monitoring, but ACRO’s Doug Peddicord says agency needs to take a more straightforward, proactive approach to encouraging the move away from 100% source data verification.
Digitizing data collection and monitoring has taken longer than desired due to various challenges, including resistance to change, unanticipated burdens and trial complexity, officials from ACRO and Medidata say, countering US FDA Commissioner Gottlieb’s criticisms that CRO business practices are holding back change.
Better use of digital tools to capture – and audit – data can help lower developmental costs, US FDA commissioner says, urging a move away from manual processes ‘perpetuated by entrenched players like contract research organizations that profit off the old ways of doing things.’