Background: Efficacy and safety profiles of new medicines are extensively studied before market entry. However, this is usually done in a controlled environment and in a homogeneous and relatively small sample, and thus not reflecting the total span of the target population. Therefore it is of utmost importance to monitor the risk/benefit balance and adverse effects of medicines after market entry.
Aim: To create a registry based on real-world data that rapidly generates information about adverse events and the risk/benefit balance of (new) medication. We focus on patients with overactive bladder (OAB), since this is a frequently occurring disease for which a new medication has entered the market recently. OAB acts as the first use-case for this new registry, but the new registry can be applied flexibly to any (new) medication and disease.
Method: Eligible OAB patients will be selected on the basis of electronic health record data of general practices participating in NIVEL Primary Care Database and will be invited for participation via a trusted third party. The patient perspective will be included through a series of questionnaires. The registry combines results from the patient questionnaires and routinely recorded data in primary care. Patient questionnaires and feedback portal will be developed in collaboration with ‘Stichting Bekkenbodem Patiënten’.
Result: Safety issues of new medication will be rapidly detected and reported and the risk/benefit balance of new and existing treatments can be compared. Participating patients and GPs will receive regular feedback, resulting in better treatment. The registry provides a wealth of data available for research, which will provide input for policy decisions (e.g. guideline development or funding). The developed methodology can be easily transferred to other medicines and health problems.