How are adverse event data collected on the BSRBR-RA Study?

An adverse event is “any untoward medical occurrence in a patient being administered a pharmaceutical product, which does not necessarily have a causal relationship with the product.”

Details of adverse events experienced by participants whilst on the study are collected on scheduled follow-up forms. This includes all events, whether the participant is still receiving treatment or not, and whether the event could be related to the therapy or not.

Why is collecting adverse event data important?

The collection of adverse event data is a core feature of the BSRBR-RA. These data form the basis of safety analysis conducted by our researchers. We rely on health professionals at our registered hospital sites to provide us with accurate, up to date adverse event information in order that these data can be analysed and the safety of drugs can be monitored.

What happens to adverse event data when it is received into the BSRBR-RA Database?

Once a follow up form has been completed by the hospital and verified by the Project Administration team, any adverse event data that has been reported are forwarded to the Pharmacovigilance (drug safety) team, who then review the information.

An event may be marked as a Serious Adverse Event (SAE) if it meets our defined seriousness criteria (for example, if the participant was hospitalised overnight or received IV antibiotics). The team may also request additional information relating to the event from the hospital site, if needed.

The event is then clinically coded using the Medical Dictionary for Regulatory Authority (MedDRA). This provides a ‘standardisation’ of descriptive clinical data provided by clinicians and supports the BSRBR-RA’s researchers in performing important drug safety analyses.

How are these data used by researchers?

The researchers working on the study extract a dataset from the study database to analyse, which includes adverse events with the MedDRA codes that they are interested in. A recent example of this can be found on our recent blog post from Dr Kim Lauper. Her work on nbDMARDS looked at serious infection adverse event data, including Mycobacterium tuberculosis.

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