registry vs registry studyA ‘Registry’ is the Same as a ‘Registry Study’…Yes? No!

Registry vs registry study – We often use the terms ‘registry’ and ‘registry study’ to mean the same thing. But they are actually different.

According to the EMA, a patient registry is a long-term, open-ended data collection system that uses observational methods to collect data on a patient population. The type of data (real world data) collected in a patient registry is defined by a particular disease, drug exposure or condition (e.g. age, pregnancy, specific patient characteristics). Whereas, a registry study seeks to answer a specific research question and parameters such as duration, patient population, data to be collected (and analysis to be performed) are defined (and constrained) by a study-specific protocol (see types of real world study). The data collected in a registry may be used for the purpose of a specific study (EMA/763513/2018).

The EMA even acknowledges that regulators have sometimes requested marketing authorisation holders (MAHs) to establish a registry, although the objective was to perform a registry study e.g., a post-authorisation safety study (PASS) to monitor the safety of a product (EMA/763513/2018).


Important Differences Between a Registry and a Registry Study

The between a registry and a registry study is important because the regulatory, methodological, operational and quality considerations can differ significantly between a registry and a registry study (see Table 1).


Table 1 – Important Differences Between a Registry vs Registry Study


As explained in a recent EMA publication (EMA/763513/2018), the main differences between a registry and a registry study are summarised in Table 1 and include the following aspects:

  1. Nature: a patient registry is a data collection system. A registry study is an investigation set up to answer a research question that uses data collected in the registry, and which may be initiated, managed or financed by a pharmaceutical company, a regulatory authority or another organisation.
  2. Timelines: a disease registry is a long-term endeavour and in principle it has no end. Timelines are driven by schedules for data collection (schedule of medical consultations or other encounters between patients and registry participants) and for routine data analyses. On the other hand, timelines for a registry study are driven by the time needed to collect or extract the data relevant for the specific study objective and to perform the analyses.
  3. Patient enrolment: patient enrolment in the registry should be exhaustive within the boundaries defined by the purpose of the registry (for example, all patients diagnosed with a disease in a region), while the study population should be defined in line with the research objective and may be a subset of the registry population.
  4. Data collection: depending on the purpose of the registry, different types of data can be collected, such as data on demographic characteristics, treatments, diseases, patient-related outcomes or comorbidities. In a study, data collection or extraction is restricted to the data necessary to investigate the research question, including data on potential confounders and effect modifiers. A specific study may also require additional data collection from other sources if these data are not routinely collected in the registry.
  5. Analysis plan: data analysis in a registry is generally performed at intervals based on patient accrual or time schedule and it follows a routine analytical plan with additional ad-hoc analyses performed by the registry coordinator or registry participants. In a study, key elements of the planned statistical analysis should be described in the protocol, supplemented as required with a separate Statistical Analysis Plan (SAP). As with the protocol, deviations to the SAP following the start of the study should be accompanied by a formal amendment process. Registries and registry studies may face different methodological and analytical issues.
  6. Collection and reporting of suspected adverse reactions: disease registries conducted by organisations such as academia or medical research associations should follow the national requirements as regards the management of safety data. Any active data collection system put in place in a disease registry and initiated, managed or funded by a MAH to collect and record suspected adverse reactions to one of its medicinal products should follow the regulatory framework for PASS. In registries without active safety data collection, health care professionals (HCPs) and patients should be reminded of the possibility to report suspected adverse reactions to the MAH of the suspected medicinal product or to the concerned competent authority via the national spontaneous reporting system. Any noxious or unintended response to a medicinal product notified to the MAH should be managed by the MAH as a spontaneous report of a suspected adverse reaction. For registry studies, requirements to MAH for suspected adverse reactions differ between studies with a design based on primary or secondary data collection. Any system for collecting, reporting and analysing adverse events put in place should be described in the study protocol.
  7. Data quality control: measures for data quality control should be routinely in place in a registry and these measures therefore also apply to the data and procedures used in a study. Additional measures may be needed for a specific study, for example to verify the completeness of the information on some data elements.
  8. Regulatory status: by nature, a registry is observational, i.e. non-interventional; on the other hand, a registry study may be non-interventional or interventional, if additional treatment is given.