Clinical research

Clinical Trials and E-Health: Impact of New Information Technology Applied to Clinical Trials (Including Source Data-Medical Records) and to Human and Drug Research

¹ Laboratoires MSD-Chibret, Paris, France
² Délégation Régionale à la Recherche Clinique et à l’Innovation, AP-HM, Marseille, France
³ Agence Française de Sécurité Sanitaire des Produits de Santé, Saint-Denis, France
⁴ Unité d’Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France

Correspondence and offprints : Jean-Charles Reynier, Délégation Régionale à la Recherche Clinique et à l’Innovation, AP-HM, CHRU de Marseille, 13354 Marseille Cedex 05, France. E-mail: JCREYNIER@ap-hm.fr

Received: 4 March 2010
Accepted: 29 March 2010

Abstract

Within the last few years, new technology has come to play an important part in our professional and private daily environment. Healthcare has not escaped this progressive mutation with computers reaching the bedside. Clinical research has also shown growing interest in these new tools available to the clinical investigator, the patient, as well as to specialist departments for diagnosis and follow-up of patients, and to the different professions in clinical research. If the use of new technology seems to make life easier, by centralizing data or by simplifying data-sharing between different teams, it is still a matter of private data which must remain reliable, confidential and secure, whether it is being used in ordinary healthcare or in academic or industrial research.

The aim of the round table was to estimate the impact of new information technology applied to clinical trials (including source data-medical records) and to human and drug research. First, an inventory was made of the development of these new technologies in the healthcare system. The second point developed was identification of expected benefits in order to issue guidelines for their good use and hazard warnings in clinical trials. Finally, the impact of these new technologies on the investigator as well as the project manager was analysed.