Adverse Effects of a Multicentre System for Ethics Approval on the Progress of a Prospective Multicentre Trial of Cancer Treatment: How Many Patients Die Waiting?
Internal Medicine Journal 2007 October; 37(10): 680-686
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A Prospective Monitoring of Fatal Serious Adverse Events (SAEs) in a Dutch Colorectal Cancer Group (DCCG) Phase III Trial (CAIRO) in Patients With Advanced Colorectal Cancer Mol, L.; Koopman, M.; Ottevanger, P.B.; Punt, C.J.A. (2010-02)BACKGROUND: Early and correct assessment of treatment-related mortality is highly important in clinical cancer trials. However, no data are available on the quality of safety monitoring. PATIENTS AND METHODS: An on-site ...
Tully, Joanna; Ninis, Nelly; Booy, Robert; Viner, Russell (2000-04-29)OBJECTIVE: To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. DESIGN: Prospectively collected data from a multicentre study ...