FDA, EMA ad­vise on risk-based mon­i­tor­ing in clin­i­cal tri­als

US and EU of­fi­cials ex­plained on Wednes­day what their re­spec­tive reg­u­la­to­ry agen­cies look for in clin­i­cal tri­al risk-based mon­i­tor­ing (RBM) and how RBM can im­pact re­view times.

Un­der a co­op­er­a­tive agree­ment with the FDA, the Duke-Mar­go­lis Health Pol­i­cy Cen­ter con­vened the pub­lic work­shop in Wash­ing­ton, DC for a de­bate on im­prov­ing the im­ple­men­ta­tion of RBM in clin­i­cal tri­als by iden­ti­fy­ing how reg­u­la­tors can help with some of the cur­rent bar­ri­ers to wide­spread adop­tion of RBM. Par­tic­i­pants looked for clar­i­fi­ca­tion around how reg­u­la­tors’ ap­proach­es to RBM dif­fer.

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