FDA Urges Centralized Clinical Trial Monitoring Over Frequent On-Site Visits - Guidance
This article was originally published in The Pink Sheet Daily
Recent Duke University survey found that firms predominately conduct frequent visits to each clinical investigator site but "the rationale behind any specific monitoring approach does not appear to be evidence-based."
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Recent Q&A draft guidance is aimed at assisting sponsors in planning and conducting risk-based approaches to monitoring, but ACRO’s Doug Peddicord says agency needs to take a more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.
Agency yields to some, denies other industry requests in final guidance that declines to lay out one prescriptive monitoring path.
The agency estimates that 88 sponsors will develop approximately 132 monitoring plans annually, as recommended in FDA’s draft guidance on oversight of clinical investigations; CDER will not be conducting prospective reviews of these plans but may do a pilot program in the future.