XVI.Add.II.2.3. Registries

Patient or disease registries as defined in the Guideline on Registry-Based Studies5 may play an important role for evaluating the effectiveness of RMM by monitoring the use of medicines or health services, thus collecting data relevant to determine behavioural or health outcomes. Behaviours relevant to RMM include e.g. changes in prescribing patterns, usage of diagnostic tests identifying risk factors for adverse reactions or attending teratogenic risk counselling. Registries may be beneficial for collecting data for specific populations such as patients with rare diseases, patients who require highly specialised healthcare interventions, or pregnant women. Some registries collect additional information, such as lifestyle factors, smoking, alcohol use, nutrition, and weight, which may be risk factors for certain adverse reactions and therefore be useful for RMM effectiveness evaluation.

The financial and administrative burden and time effort for setting up tailor-made registries may limit their use solely for RMM effectiveness evaluation and access to existing registries for secondary data analysis may be preferable. Important limitations to be considered are voluntary patient enrolment which may affect accrual rates and introduce selection bias, data quality issues or missing data (12,13).

A registry-based evaluation of the effectiveness of RMM should follow the Guideline on RegistryBased Studies6 .