Their frequency is showing net growth.

Various Forms:
• Registry; Observatory
• Pharmaco-Epidemiology; Epidemiology
• Risk Factors research ; Pharmaco-Surveillance study
• Survey

Examples of non-interventional studies that B&I has led recently:

- Register type database; requested by the authorities, on the prescription of surfactants on premature babies.
The objective was to confirm the current indications. 1250 premature babies where included and followed over 4 years. This represents one third of premature babies in France yearly. The confirmation was obvious: 3 repeated instillations instead of only 1.

- Logistical platform to follow the launch of an anti-hypertensive among 6000 physicians. Access organized into a hierarchy for the customer (representation, marketing); access for the investigators.

- Interview Questionnaire for 3000 patients in a controlled-case study (26,000 patients in Europe and Australia). Computer assisted interview, patented by the University of Amsterdam. The main cases are bronchial cancers, and the control group was made up of non- tobacco related cancer patients (prostate and breast). This direct interview approach is very gratifying for the patients who are questioned, and this same technique can be applied in various clinical situations.

The regulation process is very different from that of interventional studies and trials. The 2001/20 directive excludes non-interventional studies from its field of application.

The authorization circuit passes by the “CCTIRS”, the “CNIL”, the “CNOM” (Respectively Scientific, Informatics & Liberties and Medical Committees) and if necessary by an EC.