Purpose

GEREQ (Gestion recherche Québec) Infrastructure development to promote clinical research in Quebec

Issues and Needs

In the short term, the development of clinical research in Canada will be catalyzed by a variety of impulses related to recent changes in Canadian regulation and the marked and projected enhancement of public and private funding in this area. However, despite the international recognition that several medical investigators have developed in most therapeutic fields, the Quebec university hospital environment is far from competitive in its ability to attract investment in the management of R & D projects. major clinical. 

Among the findings of recent reports on the state of clinical research in Quebec, five main findings summarize the problem underlying the weak development of public clinical research in comparison with other Canadian provinces: Quebec’s insufficient productivity in research clinical, the scarcity of major clinical trials piloted and managed in Quebec, the underdevelopment of the clinical research culture and the lack of a permanent infrastructure supporting the implementation and management of major clinical studies. To fill these gaps, the Quebec university clinical research community emphasizes with its massive and diversified support for the GEREQ project, the urgent need to develop on an operational basis three essential levers: 

1) methodological expertise according to the rules of epidemiology and experimental medicine; 2) a strong and sustainable management infrastructure that allows routine, high quality major studies to be completed in accordance with the requirements of international regulatory authorities; 3) new ways of accessing patients via structural links with patient databases. 

Project Purpose

The purpose of this project, entitled GEREQ (“Clinical Research Management Quebec”), is to develop a platform for managing major clinical research projects that will also be used to teach clinical research and create links. Structures for Access to Patients. 

This platform will be designed as a “tailor-made” project and data management service center for clinician researchers at clinical research centers, centers of excellence, and academic / academic centers interested in developing their research capacity. clinical, to increase the level of public and private funding and the quality and scientific visibility of research projects that are clean or carried out through various consortia. By pooling and centralizing expertise and specialized infrastructure, the platform will manage the necessary critical mass of resources (professional and technical) to ensure substantial economies of scale, 

This platform, located on “neutral” ground outside the universities/centers / institutions, will also serve as a privileged place for practical training courses on methodology and clinical (research) good practices for the various professionals in clinical research from different institutions. 

Finally, this platform will serve as a communication center and integrating factor of public clinical research activities in Quebec by 1) the creation of bridges and working protocols with the various satellite units for clinical research developed (or to be developed ) in Centers of Excellence, UHC and other partners; 2) creating links with existing structures and databases (RAMQ, Conseil du médicament, IRIS Project, etc.); 3) by creating international links with similar platforms. 

The project and its objectives: April 2001-March 2004

The project is articulated on five axes of work, each with general objectives and measurable performance indicators (Ans 1,2, 

Axis 1: Management Platform: Develop (including computer and technical work, standard operating procedures, etc.) set up (including a web connection) and operate the centralized clinical management platform for clinical studies. at the provincial level, from a transfer of technology and knowledge of a core of expertise and resources already functional and recognized 2 in Quebec. 

Axis 2: Training and teaching: Promote and facilitate the implementation of training by Quebec universities through the development of training material to be put on the web, practical training protocols at the platform and training sites. structural organization of internships. 

Axis 3: Satellite research units in the institutions: Evaluate the optimal mode of implantation, support the setting up of 6 or 7 pilot units of clinical research in hospital-university institutions as a relay of the platform in each institution or centre. 

Axis 4: Promotion of the platform: Develop promotional material (web and other promotional vehicles) and presentation of platform services to centres, institutions, community of researchers in Quebec, industry and contacts International. 

Axis 5: Links with existing infrastructures: Develop (exploration of domains and action plans) structural links with patient databases and with the various potential users of the platform. 

Axis 6: International Links: Develop (exploration of domains and action plans) (eg Baltimore, Dukes in the United States, MacMaster in Canada, Lyon in Europe) links with similar platforms. 

Potential users of the project

The users of the platform will find themselves mainly in the Quebec public sector: researchers-clinicians interested in setting up large-scale clinical studies funded by the Canadian, Quebec and international public granting agencies; FRSQ thematic networks teams, centres of excellence in clinical research, public health researchers, those of the Technology Assessment Board. Some will come from the university-hospital environment outside Quebec. The platform will also be of interest to the biopharmaceutical industry through research practices that adopt high-quality standards, based on multidisciplinary expertise, synergy with consortia of investigators specialized in certain therapeutic fields and on ‘