Department for sponsorship of clinical studies
The Department for Sponsorship of Clinical Studies (SPEC) is responsible for sponsorship and management of national and international Gustave Roussy clinical studies. This department conforms to the requirements of the European Directive (2001/20/CE) relating to the conduct of clinical trials. It contributes actively to the development of clinical research in France by participating in the Coordination of Institutional Sponsors (CPI) group and in the Delegations to Clinical Research and Innovation (DRCI) group. These groups were established by the Ministry of Health. It also participates in proposing legislative measures and good clinical practice.
In 2014, 95 studies were in progress, 57 of them being in the course of recruitment. Of these 57 studies, 12 were international clinical trials. In total, no fewer than 8 new trials were initiated in 2014 and 349 visits were made to participating centres to ensure that the trials were being well conducted in accordance with current legislation.
Since 2013, steering meetings have been organised by Clinical Research Associates (ARC) from the Department, which bring together all the trial professionals so that a better picture of ongoing clinical studies may be obtained.
The constant increase in the number of trials and their growing complexity requires continuing adaptation on the part of SPEC, so that the high quality of the research can be ensured while the rights of the patient, the research partner, are not abrogated. This is reflected in the institution of new validation steps, regular monitoring of Clinical Research Organizations, better preparation of the processes of the project, adjustment of monitoring taking account of the identified risks, continuing audit programmes and the maintenance of constant regulatory surveillance.
Tasks and goals
- To guarantee that studies are conducted ethically and conform to current national and international regulations (submission of studies to health authorities and ethics committees and international regulatory coordination). To put necessary quality control measures into practice;
- Implement and supervise national and international studies by coordinating the various professional participants in the research and by providing help with production of documents and for the logistics of the research;
- To ensure proper quality control and coordination of research projects (putting in place organisational measures, quality control of data gathering, traceability of drugs) in order to guarantee patient safety and adherence to Good Clinical Practice (GCP);
- To carry out budgetary assessment and financial monitoring of studies (negotiation of contracts with industrial partners and service provider companies), so as to remain within the financial limits determined by industrial support, the public grants.
A growth area
In conformity with the Cancer Plan, patient information sheets are submitted for review, opinions and advice to the Patient Committee of the Cancer League prior to commencement of the trial.