Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.
BACKGROUND
A public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials.


METHODS
We performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of <15 % of trials sites without patients enrolled.


RESULTS
In 2013, the median delay to contract signature was: 55 days, compared with 76 days in 2008 (27.6 % reduction), 50.5 % of all sites and 58 % of sites with a dedicated CRA included ≥80 % of the planned number of patients compared with 44.8 % in 2008 (12.7 % increase) and 21.3 % of all sites and 9 % of sites with a dedicated CRA closed with no patients included, compared with 26.4 % in 2008 (19.3 and 65.9 %, respectively).


CONCLUSIONS
These results provide evidence that it is possible to improve a country's attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western Europe to improve Europe's attractiveness to industry-funded trials.
Centre National de Gestion des Essais de Produits de Santé, 3 quai des Célestins, BP2251, 69229, Lyon, Cedex 02, France. bordet@univ-lille2.fr.
Régis
R
Bordet
Centre National de Gestion des Essais de Produits de Santé, 3 quai des Célestins, BP2251, 69229, Lyon, Cedex 02, France. m.lang@cengeps.fr.
Marie
M
Lang
Centre National de Gestion des Essais de Produits de Santé, 3 quai des Célestins, BP2251, 69229, Lyon, Cedex 02, France. c.dieu@cengeps.fr.
Christelle
C
Dieu
Centre National de Gestion des Essais de Produits de Santé, 3 quai des Célestins, BP2251, 69229, Lyon, Cedex 02, France. nathalie.billon@sanofi.com.
Nathalie
N
Billon
Centre National de Gestion des Essais de Produits de Santé, 3 quai des Célestins, BP2251, 69229, Lyon, Cedex 02, France. jp.duffet@cengeps.fr.
Jean-Pierre
JP
Duffet
D035843:Biomedical Research / Q000706:statistics & numerical data* / Q000639:trends; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D005060:Europe; D005602:France; D006801:Humans; D011446:Prospective Studies; D055818:Public-Private Sector Partnerships / Q000458:organization & administration / Q000706:statistics & numerical data* / Q000639:trends; D012108:Research Personnel / Q000706:statistics & numerical data*; D013997:Time Factors