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 contr ast to phase-IV trials-are not subject to the regulations of SS 40, 41 of t he German Drug Law and national and international Recommendations on Good C linical 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, surveillances studies may have an additional regulatory impact. Indeed, th ey may be accepted as a relevant extension to the documentation on both saf ety and efficacy and in some cases even as an alternative to the tedious ex perimental investigation thereof, provided they meet newly defined quality criteria (that are discussed here more extensively). Although not developed to this purpose and although these recommendations are mainly formal with some relevant shortcomings in defining content quality, they are an importa nt source of reference for the individual physician to guide his decision a bout the value and acceptability of any surveillance study, including those not primarily intended to be used in a regulatory context.