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|Articles|July 31, 2013
Jules Mitchel: Thoughts on Risk-Based Monitoring
Jules Mitchel of Target Health discusses risk-based monitoring trends in the clinical trials industry
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Jules Mitchel of Target Health discusses, his views on its importance of risk-based monitoring in the clinical trials industry, now that is such a popular topic.
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In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.
The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.
Why clinical development’s next AI bottleneck is not the model, but the system around it.
In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.
FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines
The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.
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Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.
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