Difference between a product registry and a patient registry
When a new medicine is approved to treat a health condition, the researchers or pharmaceutical company running the clinical trial are responsible for monitoring its long-term effects. This is part of something called ‘pharmacovigilance’ – the practice of monitoring the effects of medical drugs after they have been licensed to identify previously unreported adverse drug reactions.
Product registries are set up to collect this information related to pharmacovigilance. They are different to patient registries as they only include people taking the medicine in question and only collect information on the drug’s effects. Patient registries, on the other hand, can include data from anyone living with a condition, and these patients may use a wide range of medicines or none at all.
Historically, the majority of registries were product registries. However, recently there has been a large international shift towards patient registries because of the amount of data they can collect and the multiple purposes they can be used for. As a result, new patient registries may wish to consider using a system which would allow a pharmaceutical company to integrate pharmacovigilance measures in the future, thereby preventing duplication of information and efforts.
Differences between a patient registry and a natural history study
Patient registries collect information from the whole patient community on a wide range of aspects for multiple purposes and tend to be relatively broad in scope. Registries may be used to collect disease information, recruit patients for trials, monitor patient care, observe patient behaviour patterns and support reimbursement discussions.
Natural history studies are often confused with patient registries but the two are distinct. Natural history studies have a very specific goal to track the course of a disease over time by examining patient demographics, genetic differences and other factors that are related to the disease and its outcome. They follow a distinct cohort of patients for a prolonged period of time to understand how a particular disease progresses through patients’ lives. By understanding this, it allows patients to know what to expect and helps doctors/advocates to develop disease management guidelines, ensuring that patients get the scans, tests, treatments, support and care that they need at the right time.
Confusion between the two can occur as patient registries often incorporate natural history measures or are used to run natural history studies. For instance, they might ask patients to regularly provide updates on the symptoms they are experiencing. However, incorporating natural history measures in a registry is not always practical or necessary.
The lines between the two can blur in the field of rare diseases. Often, there is no clear picture of disease progression, and therefore natural history measures often need to be incorporated into registries. ‘Registries for evaluating patient outcomes: A user’s guide’ gives the example of a lysosomal storage disorders registry. Where patients with these conditions previously did not survive into their 20s, they may now be living into their 40s and 50s. Crucially, a registry allowed this uncharted natural history to be captured.