Hospital PASS studies: conducting real-world observational studies in secondary care
Our article in the Spring edition of Pharmafile explains our unique SCEM method for conducting PASS studies in hospitals and specialist care in the context of rivaroxaban.
The DSRU developed a unique methodology to conduct Post-authorisation Safety Studies (PASS) in hospitals and specialist care in the UK, known as Specialist Cohort Event Monitoring (SCEM) in 2010 (see reference below). This technique was developed to address the need for safety studies in secondary care, specifically for patients who receive initial or all drug treatment in hospitals or hospital outpatient clinics. This method is ideally suited to conducting PASS studies on Direct Oral Anticoagulants, such as rivaroxaban. The steps of the SCEM method are listed in Box 1 below. Key points about SCEM include the gathering of event data from the medical records of consented patients by hospital prescribers or care teams, and the DSRU’s collaboration with the National Institute for Heath Research Clinical Research Network (NIHR CRN) and other networks across the UK to identify secondary or specialist care prescribers in the relevant speciality.
We have completed four PASS studies in secondary or specialist care, with more in the pipeline. Details are available here.
Further information about our SCEM methodology for conducting PASS in secondary and specialist care, including case studies, is available here.
If you wish to discuss a possible PASS in primary, secondary or specialist care (or a combination), please get in touch.
Reference for our Hospital PASS methodology:
Layton D, Shakir SA. Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance. Drug Safety. 2015;38(2):153-63.