FDA ad­dress­es ex­pand­ed use of da­ta mon­i­tor­ing com­mit­tees in draft guid­ance

The FDA laid out con­sid­er­a­tions for how spon­sors should lever­age com­mit­tees to help an­a­lyze clin­i­cal tri­al da­ta in draft guid­ance pub­lished Mon­day. The draft ar­rives as the use of these da­ta mon­i­tor­ing com­mit­tees has in­creased over the past sev­er­al years.

The 29-page doc­u­ment, once fi­nal­ized, will re­place the FDA’s 2006 guid­ance on the top­ic, ti­tled Es­tab­lish­ment and Op­er­a­tion of Clin­i­cal Tri­al Da­ta Mon­i­tor­ing Com­mit­tees. The up­dat­ed guid­ance ad­dress­es an in­creased use of da­ta mon­i­tor­ing com­mit­tees over the past sev­er­al years, as well as the ex­pand­ed scope of what da­ta mon­i­tor­ing com­mit­tees are used for.

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