Sense and nonsense of post-authorization surveillance

Post-authorization surveillance studies analyze the intended use of medicat ions in accordance with their authorized labeling. They are characterized b y the principle of non-intervention, i.e. they do not take influence on the decision whether or how to treat and to survey treatment in the individual patient. These aspects define the difference between surveillance studies and phase-IV clinical trials. In consequence, surveillance studies - in con trast to phase-IV trials-are not subject to the regulations of 40, 41 of th e German Drug Law and national and international Recommendations of Good Cl inical Practice (GCP). In essence, they are pharmaco-epidemiological investigations that make use of personified patient data. Within the context of the European regulatory policies they are part of the overall pharmacovigilance effort. In Germany, surveillance studies may have an additional regulatory impact. Indeed, the y may be accepted as a relevant extension to the documentation on both safe ty and efficacy and in some cases even as an alternative to the tedious exp erimental investigation thereof, provided they meet newly defined quality c riteria (that are discussed here more extensively). Although not developed to this purpose and although these recommendations are mainly formal with s ome relevant shortcomings in defining content quality, they are an importan t source of reference for the individual physician to guide his decision ab out the value and acceptability of any surveillance study, including those not primarily intended to be used in a regulatory context.