Implementing Good Clinical Practice in Two Noncommercial Phase II Studies in Children with Cancer

Abstract

In noncommercial clinical drug research theimplementation of the principles of Good Clinical Practice(GCP) has been criticized for introducing unnecessarybureaucracy at the expense of scientific activity, especiallywhen small populations such as children or patientswith orphan diseases are concerned. Patients andMethods: From May 2003 to September 2005, we conductedtwo prospective open-label multicenter phase IIstudies in pediatric oncology. Aside from medical questions,these studies set out to explore the requirementsaccording to the essential standards of the ICH-GCPGuideline in anticipation of the implementation of the EURegulation in German Drug Law in August 2004; the latter,prospective investigation was initiated by the CoordinatingCenter for Clinical Trials (KKS). Results: The mainGCP requirements were systematically reviewed and criticallydiscussed by focusing mainly on the situation ofnoncommercial pediatric drug research. Conclusion:While putting GCP into practice in academic research increasescosts, the challenge will be to apply these guidelinesto good effect, for better quality and increased evidence.Implementing Good Clinical Practice in TwoNoncommercial Phase II Studies in Children with CancerAlexandra Wagner-Bohna Anita Ripkens-Reinharda Gerlinde Benninger-Döringa Joachim Boosba Coordinating Centre for Clinical Trials, University Hospital of Münster,bDepartment of Pediatric Hematology and Oncology, University Children’s Hospital of Münster, Germany