ABSTRACT
PURPOSE: The aim of non-interventional studies (NIS) with medicinal products is to investigate the use of authorized medicinal products in daily routine. In the past, this type of study has been subject to frequent criticism, and many recommendations have been published. The aim of our study was to assess the quality of NIS study protocols. METHODS: Nearly all NIS study protocols submitted to the German Federal Institute for Drugs and Medical Devices (BfArM) within a period of one year could be analyzed. The protocols were evaluated in terms of objectives, methods and included patients, as well as with regard to their compliance with quality recommendations for NIS by federal authorities and pharmaceutical industry associations. RESULTS: The 136 NIS available for study were scheduled to enroll approximately 330,000 patients (2,500 patients per study) and 43,000 healthcare professionals. Of these NIS, 58 % were performed with medicinal products that had been authorized within the past 5 years; however, 68 % of the investigated active pharmaceutical ingredients were older than 5 years, and 19 % were even older than 19 years. Only 56 % of the protocols provided information on publication policy, and 65 % required the involvement of ethic committees. The adherence to current quality recommendations was average, but the compliance of NIS performed by member companies of the Association of Research-Based Pharmaceutical Companies was significantly higher than that of other sponsors. CONCLUSIONS: Current quality recommendations are still not fully implemented in most NIS protocols. Therefore, the scientific value of many NIS is still questionable, and the criticism that NIS are mainly conducted for marketing reasons could not be refuted by the data analyzed here.