Efficient PASS based on bespoke data collection in secondary care
One of our key capabilities is to design and conduct PASS studies using bespoke data collection in primary, secondary or specialist care. While we use electronic health records (EHR) as the data source for many of our studies, in the UK there is insufficient secondary care EHR data available for post-authorisation studies. Bespoke data collection provides a viable alternative when EHR databases, such as CPRD, lack the necessary detail and with the correct experience and expertise, can be a straightforward approach to answer the research question. Read our case study below to understand our method for conducting these PASS studies.
Case study: PASS based on collection of bespoke safety and utilisation data in secondary care
We received a request from a Marketing Authorisation Holder (MAH) for a post-authorisation study to assess the utilisation and safety of their product, an intravenous analgesic used in the post-operative setting in the UK.
- We designed a study suited to the UK secondary care setting which used bespoke data collection through electronic data capture.
- Prescribers or centres specialising in anaesthesia or surgery were recruited to the study via the National Institute for Health Research (NIHR) Clinical Research Networks (CRN).
- Patients were enrolled anonymously into the study by prescribers.
- Prescribers or the care team collected the anonymised data needed to meet the study objectives via electronic data capture, as part of routine clinical practice.
- Data was collated, coded and analysed. Interim and final reports written and submitted to the MAH.
Contact us if you are interested in post-authorisation studies based on bespoke data collection in primary or secondary care.