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Publications

Journal Article Ahead of print

PubMed: 41478757 DOI: 10.1016/j.therap.2025.11.008

Accelerating recruitment in clinical trials: A strategic challenge.

Therapie

Authors: Dominique Deplanque, Ariane Galaup, Christine Trillou, Philippe Barthélemy, Arnaud Bayle, Lionel Da Cruz, Erik Domain, Michael Duruisseaux, Cécile Fouret, Laetitia Gambotti, Cécile Girault, Damien Gonthier, Aurélie Guérin, Antoine Hommais, Jean-Sébastien Hulot, Dorothée Ko, Marie Lang, Vincent Laugel, Bruno Laviolle, Christophe Le Tourneau, Julie Oheix, Tabassome Simon, Jérémy Skryspski

Affiliations

  • University Lille, Inserm, CHU Lille, CIC 1403 - Centre d'investigation clinique, 59000 Lille, France.
  • LEEM, 75017 Paris, France.
  • F-CRIN (French Clinical Research Infrastructure Network), CHU de Toulouse Purpan, 31059 Toulouse, France.
  • Hôpital Antoine Béclère, AP-HP, 92140 Clamart, France; PHFB Consulting, 92170 Vanves, France.
  • Bureau biostatistique et épidémiologie, Gustave Roussy, université Paris-Saclay, Inserm, CESP U1018 Oncostat, Ligue contre le cancer-Université Paris-Saclay, 94800 Villejuif, France.
  • Direction générale de l'offre de soin, Ministère en charge de la santé, 75007 Paris, France.
  • Direction de la recherche clinique et de l'innovation, AP-HP, Hôpital Saint-Louis, 75010 Paris, France.
  • Institut de cancérologie des Hospices civils de Lyon-Réseau GCO, 69002 Lyon, France.
  • Medtronic, 75014 Paris, France.
  • Agence de l'innovation en santé, 75007 Paris, France.
  • Fédération francophone de cancérologie digestive, faculté de médecine, 21079 Dijon, France.
  • Collège national des généralistes enseignants - Collège académique, 75011 Paris, France.
  • Pfizer, recherche clinique, 75014 Paris, France.
  • Département recherche clinique, Institut national du cancer (INCa), 92513 Boulogne-Billancourt, France.
  • Université Paris Cité, Inserm, CIC 1418, PARCC U970, F-CRIN INI-CRCT, 75015 Paris, France; AP-HP (HEGP, CIC), 75000 Paris, France.
  • MSD France, 92800 Puteaux, France.
  • Comité national de coordination de la recherche (CNCR), 75014 Paris, France.
  • Centre d'investigation clinique, hôpitaux universitaires de Strasbourg, 67000 Strasbourg, France.
  • Univ Rennes, CHU Rennes, Inserm, centre d'investigation clinique 1414 de Rennes, service de pharmacologie clinique, 35000 Rennes, France.
  • Institut Curie, 75005 Paris, France.
  • Syndicat national de l'industrie des technologies médicales (SNITEM), 92400 Courbevoie, France.
  • Sorbonne université, Assistance publique des hôpitaux de Paris, hôpital Saint-Antoine, service de pharmacologie et plateforme de recherche clinique de l'Est parisien (URCEST_CRCEST-CRB), F-CRIN FACT, 75012 Paris, France.
  • AFCROs, 92100 Boulogne Billancourt, France; ICTA PM, 21121 Fontaine-lès-Dijon, France.

Abstract

Clinical research provides an important gateway to therapeutic innovation and, in many cases, national participation in trials can facilitate the future availability of new treatments in the country concerned. Clinical research activity in general is declining in France, especially in terms of industry-led trials; the only exception being early-phase cancer trials. There is an urgent need to boost the level of French participation in major international trials, although this will require a marked improvement in recruitment performance. Although the many factors contributing to the mediocre performance of France merit discussion, the overriding necessity is to bring forward solutions for increasing the level of participation in clinical trials going forward. It is against this background that we propose these recommendations for facilitating and increasing overall enrolment. There are a number of potential ways in which improvements could be achieved, beginning with identifying eligible patients and offering them the opportunity to take part in clinical trials, either through greater engagement by healthcare professionals or the development of decentralised trials. Other opportunities include optimising territorial coverage through inter-hospital networks or clinical trials centre networks, strengthening and improving clinical trials centre organisational structures by introducing AI-driven patient pre-screening tools, and lastly reprofiling some of the roles involved in clinical research and the provision of associated training. While some of these recommendations require regulatory changes, the majority could be implemented immediately, and would provide a rapid response to this major strategic challenge.

MeSH

Drug Therapy, Pharmacology, Research, Therapeutics