Bordet Régis, Lang Marie, Dieu Christelle, Billon Nathalie, Duffet Jean-Pierre
Centre National de Gestion des Essais de Produits de Santé, 3 quai des Célestins, BP2251, 69229, Lyon, Cedex 02, France.
BMC Med Res Methodol. 2015 Aug 19;15:67. doi: 10.1186/s12874-015-0044-8.
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.
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.
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).
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.
2007年法国启动了一项公私合营（51/49%）计划，以提高法国研究点在行业资助的国际临床试验中的吸引力。该计划制定并实施了一系列组织行动和支持行动。在此，我们报告6年后对法国研究点参与行业资助临床试验的影响评估。
我们对法国公立医院的临床研究活动进行了一项前瞻性前后对照研究，以评估CeNGEPS制定和实施的行动的影响。该计划包括一系列组织行动（建立卓越研究点、国家网络和专职临床研究助理（CRA））、支持行动（工具、模板和培训）以及根据绩效为研究点或网络进行竞争性预算分配。使用以下绩效标准评估影响：1）80%的试验点将合同签署延迟缩短至≤60天；2）至少80%的试验点纳入≥80%的计划患者数量；3）无患者入组的试验点关闭比例<15%。
2013年，合同签署的中位延迟时间为：55天，而2008年为76天（减少27.6%），所有研究点中有50.5%以及配备专职CRA的研究点中有58%纳入了≥80%的计划患者数量，相比2008年的44.8%有所增加（增加12.7%），所有研究点中有21.3%以及配备专职CRA的研究点中有9%关闭且无患者入组，相比2008年的26.4%有所减少（分别减少19.3%和65.9%）。
这些结果证明，提高一个国家在行业资助临床研究方面的吸引力是可行的。两项主要行动，即在全国建立配备训练有素的专职人员的卓越研究点以及建立临床研究人员国家网络，可以适用于西欧其他国家，以提高欧洲对行业资助试验的吸引力。
