Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

Objectives:  To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.

Design:  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.

Setting:  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.