Quality assurance measures in non-interventional studies: Results of a survey among the members of the Association of Research-Based Pharmaceutical Companies

Abstract

Research into the therapeutic efficacy of a preparation, its safety and tolerability in the human body, as well as its development into a medicinal product is governed by strict legal provisions and regulations such as those stipulated in the German Drug Law (AMG) and the German Ordinance for Good Clinical Practice in Trials on Medicinal Products for Human Use (GCP-V). In the post-marketing setting, when drugs are tested under routine conditions and in large numbers of patients, non-interventional studies (NIS), which include Anwendungsbeobachtungen (AWB) as the most common form in Germany, have shown to be effective instruments for assessing the safety of a medicinal product and for confirming the results obtained in clinical trials regarding the efficacy of the drug. NIS/AWB studies are not subject to the same strict regulations that govern the development of a medicinal product; in fact they follow recommendations such as those issued by the Federal Higher Authorities and the Expert Committee on Good Epidemiological Practice. Further provisions on NIS/AWB are laid down in the “Codex of the Voluntary Self-regulation for the Pharmaceutical Industry” and the “Common point of view of the Associations of the Pharmaceutical Industry on the assessment of criminality in the collaboration between industry, medical institutions and their staff”. In early 2007, the German Association of Research-Based Pharmaceutical Companies (VFA) consolidated the essential elements of these recommendations, supplemented them by new provisions and published the resulting document as „VFA Recommendations for the Improvement of Quality and Transparency of Non-interventional Studies“. Among other initiatives, these recommendations stipulate specific measures for quality assurance in NIS, approximating NIS standards to those applicable to clinical trials. At the same time NIS are being subjected to transparency criteria with regard to the planning, conduct and publication of the results similar to those that have long been required for clinical studies. A survey among VFA members showed that the VFA recommendations were implemented widely and successfully by the companies currently conducting NIS/AWB projects only a few months after the recommendations had been published. The number of newly initiated NIS has slightly dropped; this trend comes with an increased administrative and logistic burden, greater emphasis on medico-scientific questions, and a focus on adequate methodologies for the analysis of NIS/AWB.