In this meta study, only about one third of IBD patients reviewed would have been eligible to participate in FDA studies on the efficacy of biological agents (Adalimumab, Certolizumab pegol, Infliximab, Natalizumab, etc.) for IBD.
Most patients with moderate–severe IBD evaluated in an outpatient practice would not qualify for enrollment in a pivotal RCT of biological reagents; this finding raises important questions about their therapeutic efficacy beyond the clinical trial populations.
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