The flood of study feasibilities and the value of a centralised approach

Introduction Due to an increase in multicentric paediatric clinical trials after 2007 following the EU Paediatric Regulation, there has been a substantial increase in the number of feasibility questionnaires (FQ). Paediatric clinical trial conduct has made unique advances through the conect4children (c4c) pan-European network, funded by the Innovative Medicines Initiative (IMI2). We examined the role of a national, centralized coordination center in Belgium to pre-fill feasibility questionnaires and quality control responses from sites. Methods This report describes the 4-year learnings of prefilling and performing quality control for FQ by the Belgian Network representative. Additional information has been included from a broad survey sent to sites in the Belgian Network, of which 13 of the 15 sites have responded. Results PIs are confronted by between 10 to 50 FQ requests per year, each taking at average 60 minutes. The number of redundant questions asked by sponsors is on average 43% of the FQ. Of the 112 completed feasibilities, approximately 82% required quality control adjustments by our national coordinating center. Inconsistencies were primarily found in PIs’ report of experience, number of paediatric studies conducted, recruitment estimates and site qualifications. With a centralized and repetitive collection of FQ, a prefill of 65% of the requested information and potential corrections can be performed. A time reduction of 10 to 46% is estimated when a FQ is facilitated through the national representative. Conclusions The increase in paediatric clinical trials has substantially burdened sites within Belgium. Quality control and adjustments by a national central organization could be beneficial to increase feasibility quality and efficiency.