This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
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This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.
