Specialist Cohort Event Monitoring

A key benefit of SCEM studies is their adoption by the National Institute for Health Research (NIHR) which provides the opportunity for assistance from the Clinical Research Network (CRN). The CRN facilitates high quality research in the NHS and comprises both local CRNs and 30 speciality groups of research-active specialist healthcare professionals (HCPs), so that research can be supported both geographically and by therapy area, depending on the drug of interest.
In a SCEM study the DSRU study team first establishes a cohort of specialists prescribing the study drug, assisted by the NIHR CRN. The specialist HCP makes the clinical decision to prescribe the study drug and registers on the DSRU’s study recruitment website. The HCP or care team obtain informed consent from the patient to include them in the study and completes the baseline questionnaire using the patient’s medical records and returns to the DSRU study team for processing. After the index date (e.g. 3, 6 or 12 months after first prescription, the exact period depends on the study) a bespoke follow-up questionnaire is completed by the HCP using the patient’s medical records, then returned to the study team for processing. Selected events of medical interest, deaths and pregnancies are followed up. Data is collated and analysed.