Deborah Layton and Saad AW Shakir

Background

It is recognised that there is a paucity of data sources to conduct studies in the EU on hospitalised patients (pts) and those seeing specialists.SCEM is method which has been used to meet the requirements of Post-Authorisation Safety Studies (PASS) to address this need for systematic large scale safety surveillance of new medicines mostly initiated by hospital specialists in a hospital or other secondary care settings (e.g. outpatient clinics). To date, four SCEM studies have been included with Risk Management Plans (RMP) of recently marketed drugs.

Objectives

To discuss design considerations of SCEM.

Methods

A description of design of SCEM, incl. pt identification, specialist research frameworks, study size, data collection and study duration.

Results

SCEM assembles new user cohorts on the basis of a common exposure (study drug). The sampling frame comprises all secondary care settings likely to use the study drug in clinical practice. Specialists register within a research network established with collaborative support from the UK NIHR Clinical Research Network.Pt inclusion criteria are minimal and eligible pts for are those whom the clinical decision to treat has been made by a specialist, prior to pt consent. NHS ethics approval is required. The desired pt sample size is powered to examine primary safety issues identified in the RMP, and study duration planned to maximise cohort accrual. Longitudinal data collection (min 3 mths per pt) is supported via specialist completed questionnaires (secondary use pt medical charts). Inclusion of a comparator cohort is possible, dependent on the availability of an ideal counterfactual treatment.

Conclusion

Since the adoption of a new medicine into clinical practice in the UK is often initially facilitated by specialists, there is a need for data capture across all clinical settings to ensure that exposed populations are characterised and monitored. SCEM studies attempt to overcome some limitations of PASS ( such as potential selection bias and under-reporting) conducted exclusively in the primary care setting, or using primary care based data sources with partial information on pts health experience since specialist initiation.