Evaluation of Clinical Trials in Onco-haematology: A New Method Based on Risk Analysis and Multidisciplinarity.

BACKGROUND: European member states are increasingly vying with one another to recruit patients for clinical trials (CTs). The French national agency for medicines (ANSM) now receives an ever-growing number of CTs, extending response times. The aim of the new methodology presented herein is to reduce assessment times below the national mandatory timeframe of 60 days and to improve patient safety. MATERIALS AND METHODS: Based on an analysis of the criteria defining CTs, 4 key points were identified (safety, fragile population, loss of opportunity, design complexity) to build a criticality score which would determine evaluation type. This score also determines the resources needed (complete evaluation, multidisciplinary advice, ad hoc evaluation) and the timeframe required for appropriate analysis. All post-phase I CTs were analysed from the implementation of the new assessment method, on 01/02/2018 through to 31/12/2019. RESULTS: 447 CTs were analysed (63% industry and 37% academic sponsors). Based on a criticality scale, 27% of the CTs received a type A evaluation (complete), 37% a type B (multidisciplinary evaluation), 23% a type C evaluation (ad hoc evaluation) and 13% a type D evaluation (fast evaluation). From 2014 to 2017, 37% of the CTs were analysed within the mandatory timeframe, with a mean of 68 days, reaching a maximum of 102 days in 2017. Using this new assessment method, 92% of CTs respected the mandatory timeframe in 2019; the mean time in 2018-2019 was 34 days; Grounds for Non-Acceptance (GNA) were raised for 66% of the CTs (69% from academic sponsors and 65% from industrial firms). 3 CTs were refused. CONCLUSION: Here, we demonstrate the feasibility of risk analysis and multidisciplinarity method, which resulted in a dramatic improvement of assessment times.

[Frequency of adherent colibacillus in a population with acute pyelonephritis and a population with acute cystitis]. / Fréquence des colibacilles adhérents dans une population de pyélonéphrite aiguë et dans une population de cystite aiguë.

Urothelial adhesion of Escherichia coli is one of the principal factors of colonisation and infection of the upper urinary tract. We compared 3 measurements of bacterial adhesion: 1) Mannose-Resistant Haemagglutination (MRHA), é) Adhesion to urothelial cells, 3) Latex particle agglutination, to test 85 strains of Escherichia coli in 42 cases of acute pyelonephritis and 43 cases of acute cystitis. These tests were positive in 73.8% to 85.7% of the acute pyelonephritis population and in 4% to 2.3% of the acute cystitis population (statistically significant difference). This study confirms the major role of strains carrying type PAP adhesion in the pathogenesis of acute pyelonephritis.