A national survey on patients' enrollment rate in clinical trials: the French experience

Abstract

6601 Background: The rate of patients enrolled in clinical trials is one of the main indicators of clinical research and care activity. The French Cancer Plan (2003–2007) put on a quantifiable target of 10% of patients to be enrolled in high-quality clinical trials. To help investigators meet this objective, a substantial financial support for clinical research associates (CRA) recruitment was given mainly to University Hospitals and Comprehensive Cancer Centers. In the meantime, significant financial support was given to competitively selected projects. Methods: We carried out a national survey in 2007 in order to identify clinical research activities in oncology in France for the period from 2002 to 2006. A questionnaire was sent to University Hospitals and Comprehensive Cancer Centers and data on number of trials ongoing (open for enrolment), number of trials sponsored by the institution, number of patients enrolled and human resources (CRA) from 2002 to 2006 were collected. Data on academic and industry-sponsored trials were collected separately. Results: We showed that the number of patients enrolled in clinical trials increased continuously over the period considered, from 21,500 in 2002 to 26,700 in 2006. Based on the inclusion figures and assuming that there will be between 350,000 and 400,000 patients eligible for the clinical trials (epidemiological data), the enrolment rate for patients in clinical trials is expected to be between 7.4 and 8.5% in 2006 versus 5.8 and 6.7% in 2002. Nearly 80% of all participating patients were included in academic trials. Over 75% of patients benefited from a therapeutic trial. At last, the number of clinical trials increased by more than 20% over the same period, while the number of CRA doubled all over the French territory. Conclusions: Our results show that public intervention for improving enrolment to cancer clinical trials seems to be efficient. Other types of intervention are being considered, targeted on investigators, on patients, or on both such as the French registry of clinical trials in oncology. Future work should also consider clinical research in other institutions—local hospitals and private centers—whose research activities are increasingly growing in the cancer field. No significant financial relationships to disclose.