1- Scientific context and project objectives

A major challenge in the coming years is to maintain France’s and Europe’s lead in the field of international pharmaceutical development and research. To achieve this, it is essential to develop highly effective networks and structures, specialising in clinical trials. The Clinical Investigation Centre (CIC 501) in Clermont-Ferrand (officially recognised by Inserm in 2005), is the largest public clinical research platform in France. As a result it must actively contribute to the dynamics at regional and national level. As a multi-thematic platform, it is open to all local academic teams involved in clinical research and is also a recognised partner of numerous pharmaceutical businesses, with specific expertise in the study of medicines intended to treat pain. The CIC is seeking to become a reference centre on this theme, beyond national borders..

2- Project description

To increase the centre’s capacities and complete the application of Good Clinical Practices (international (ICH) system of Quality Assurance applicable to biomedical research), consideration has been given to computerising the means dedicated to carrying out clinical trials. The objective is to develop an automated, reliable, effective and rapid acquisition system of the few thousand (or sometimes several tens of thousands) clinical and biological data generated by each study. Moreover, current clinical research approaches integrate more and more genome, transcriptome, metabolome and proteome approaches in physiological and physiopathological explorations or for understanding how medicines work in humans. With this development taking place, the centre is undertaking to equip itself with new means for processing the data obtained through these techniques. The CIC is also currently involved in a project integrating an analysis of the transcriptome, in a national epidemiological study looking to understand the imbalances involved in stubborn neuropathic pain.

3- Public or controlled use

The clinical protocols are based on rigorous experimental plans usually involving several patients or healthy volunteers, according to a pre-defined sequence of tests that will be repeated several times in exactly the same way, to quantify the influence of the different causal factors studied (medicines, biomedical equipment). Data will be collected according to a very precise time schedule, using exploratory devices set depending on the specific objectives of each test (electrophysiological, haemodynamic, psychometric, questionnaires, etc.).

The information system developed by this project should contain various modules:

• Automatic generation of files for collecting data received from measurement devices or entered manually. Each file must be parametrisable to adapt to all scenarios.
• An automatic identification tool (badge with bar code) of the patient and medical personnel carrying out the measurement (BPC traceability).
• A secure tool for transmitting data to a centralised storage zone.
• A customer application for linking all of the data stored centrally, validating data, using specific processing tools, printing a formatted report and transmitting data to customers.
• A customer application for drawing up the visit sequence before the different modules by the patients.
• A central storage zone comprising a results database, an image server and a genome or transcriptome database associated with pain.

The technologies used will need to be tried and tested as the CIC’s work requires guarantees of quality and confidentiality (CNIL coding/anonymisation requirements) for saving data.

Due to the specific features of how a CIC is run, the system has not been designed for unrestricted application to other laboratories. It may, however, be opened (based on precise access arrangements) to other French networking clinical investigation centres.

4- Expected results

The programme has three main objectives concerning the CIC:

• Improve productivity by reducing or cutting out the intermediate stages of entering data on paper
• Increase the reliability of data collection as clinical trials are being carried out: (1) by automating the data entry procedures, (2) by standardising data in a standard output format.
• Offer new services to clinical researchers by enabling them to easily integrate data from medical imagery equipment and genome and/or transcriptome analysis techniques.

LifeGrid, the regional information system