An observational analysis of patient recruitment in clinical trials in France using real-word database PMSI

Abstract

AbstractBackgroundFrance has significant clinical research and development potential, however, struggles in comparison to neighbouring countries. A significant reason is the difficulty to recruit patients, thus causing delays in the availability of new therapies to market. IQVIA uses Health Insurance Claims Data among other data assets, to better locate patients for trials based on the potential of hospitals.ObjectiveThe aim of the study was to monitor whether an increased number of patients enrolled in clinical trials in France was observed when PMSI data supported patient recruitment, as well as describing clinical trial landscape worldwide and in Europe.MethodsWe used data from ClinicalTrials.gov and Citeline to describe the clinical trial landscape in Europe between 2010 and 2019. We also looked at the IQVIA internal clinical trial tracker, Clinical Trial Management System (CTMS) to describe IQVIA-run trials and their performance after matching trials supported with PMSI data in France. We compared the average number of enrolled patients per site in PMSI and non-PMSI supported trials according to the study phase, using a Student t-test.ResultsResults suggest that the support of PMSI on the average number of enrolled patients per site, when comparing at similar trial phase level, shows a positive trend especially for phase 4 studies (11.0 with PMSI vs 9.3 without PMSI, p=0.67), and for phases 3b, 3 and 1, when compared to non-PMSI supported studies.ConclusionsThe findings of this study suggest that PMSI use has the potential to increase patient recruitment into clinical trials run in France, rendering France more attractive in its exploitation of the clinical research potential. Optimising patient recruitment has a direct impact on the availability and timeliness of innovative therapies to market for French patients.