As illustrated in Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005–2013 (Pharmacoepidemiol Drug Saf 2017 Mar 26), the conceptual differences between registries and studies need to be clearly understood.
Patient registries are often integrated into routine clinical practice with systematic and sometimes automated data capture in electronic healthcare records, but disease, exposure or outcome-specific registries usually require recording of specific relevant data. Whilst the duration of a registry is normally open-ended, that of a study is dictated by the time needed to define and collect data relevant for the specific study objectives. Studies also often require introduction of specific procedures, questionnaires or data collection tools. Studies are set up and managed based on limited endpoints and a specific protocol, whereas patient registries are traditionally set up focusing on system(s) specifications in order to ensure a continuous, efficient and collaborative data collection; safe data hosting; accessible, retrievable, interoperable and re-usable data.
A registry can be used as a source of patients for studies based on either primary data collection (where the data collected for new patients are also used for a specific study) or secondary data collection (analogously to the use of electronic healthcare records). For this purpose, registries data can be enriched with additional information on outcomes, lifestyle data, immunisation and mortality information obtained from linkage to the existing database such as national cancer registries, prescription databases or mortality records.
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|