DiSCeRN - eviDence Synthesis of Clinical Study reports for NOACs (DiSCeRN - phase 1)

Atrial fibrillation is a condition in which the heart's rhythm is abnormal. It increases the risk of blood clots and strokes. To lower these risks, anti-clotting (anticoagulation) medication is used. These treatments aim to reduce blood clotting, but avoid increasing severe bleeds or other problems.

Currently, anticoagulation management predominantly uses warfarin, which although effective, needs patients to have regular blood tests to check the treatment is working correctly. Recently, novel groups of drugs (NOACs) have been developed which aim to reduce the risk of blood clots and strokes but may need less frequent blood tests. However, some NOACs have been found to be more harmful than warfarin and have been withdrawn from use. Other NOACs seem useful and are now recommended by clinical guidelines. It is important to know the balance of benefit and harms with NOACs compared with standard treatments, to decide which treatment patients should use.

We have carried out a review of published data on these drugs, noting their overall risks versus benefits to current treatments.

However, our review highlighted the possibility of unpublished data (which often contains negative data). To obtain additional unpublished material, we made a freedom of information (FOI) request to the European Medicines Agency (who regulate drug licensing) for full disclosure of unpublished data in relation to these drugs. We were successful in our request and now hold several large sets of additional data which must be reviewed.

This proposal therefore outlines phase 1 (development of plan) of a project to study this data with a view to completing a full detailed review in phase 2.

A full and unbiased analysis of the unpublished data is vital to ensure that these drugs are being used with all known risks and benefits.

Amount awarded: £29,328