VFA (Association of Research-Based Pharmaceutical Companies)
The German pharmaceutical company Sanofi-Aventis has conducted a survey questioning 38 VFA-member companies in Germany about clinical studies with minors in the years 2003 and 2004. In the year 2000, already, a survey had been conducted amongst member companies. This survey was aimed at surveying the scope of the clinical examinations as well as at examining them with regards to certain tendencies. Furthermore, the companies' respective experiences were to be evaluated. According to the survey's results, in the years 2003/2004 two-thirds of the companies conducted pharmaceutical studies on minors. The number of studies involving minors thus remained constant in comparison to the year 2000. For 2005/2006 no increase was expected either.
The survey further shows that most clinical studies were conducted on minors between 2 and 11 years (31 clinical examinations in total).The studies were conducted both in clinics and in cooperation with physicians in private practice.
The experiences of the VFA-companies show that the majority of companies had problems finding investigators to perform pharmaceutical tests with minors. This is assumed to be due to the lacking readiness of practitioners to conduct clinical examinations on minors.
Surveys furthermore illustrated that the ethic commissions saw the clinical studies with minors much less sceptical than did the parents. Amongst others, the contribution of the parents is, however, decisive for the studies' feasibility.
Hark, Mareile / Elvert, Gerd / Hundt, Ferdinand (2006): Arzneimittelstudien bei Kindern in Deutschland. Ergebnisse einer Evaluierung unter VFA-Mitgliedsunternehmen zur Durchführung von klinischen Prüfungen bei Minderjährigen. In: pharmind 68 (6), S.693-698.