Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines (EMA European Medicines Agency - EMA), a disease or condition, as well as in improving the quality of healthcare in general, with the overall aim of improving public health.
Registries allow us to provide a snapshot of a specific population, through a retrospective and also a prospective collection of various patient data including demographics, clinical data, diagnostic and therapeutic information. Data collection is continuous over time and unlimited in the number of patients who can be enrolled. This allows a precise reconstruction of information, through significant data on a large sample of subjects, with multiple purposes and a duration generally of no less than two to three years. These patients can then be readily enrolled in clinical studies, having already outlined the underlying, typical characteristics of the condition or illness they are suffering from, fully meeting the study's inclusion criteria, avoiding dropouts and guaranteeing the effectiveness of the research study.
Data collected comes from clinical routine or also from other registries (Real World Data - RWD). Alongside the greater flexibility of patient selection and data collection, these systems must include careful quality control strategies for the entered data.
Therefore, the initial decisions for the creation of a registry consist of identifying:
the objectives
the geographical area of reference
the structure/model of the registry
the collection system and the data ownership
the data entry strategy, through logic checks, alerts, avoiding free text input fields
the monitoring strategy of the collected data.
Data collection is now digitally based, using intuitive platforms and can also be accessible free of charge for non-profit institutions.
Despite this, difficulties are often encountered in guaranteeing the economic coverage of the registries, as they generally lack external funding and are promoted by non-profit bodies. Other difficulties are also noted, such as:
lack of accuracy in the definition of items
quality of data
compliance with privacy regulations
lack of regulatory references and guidelines on specific pathologies
heterogeneity of the operators involved.
Furthermore, data collected from registries can be used to develop studies relevant to healthcare strategy, such as in observational, epidemiological and pharmacosurveillance studies. These studies require:
a detailed protocol, characterized by specific research objectives
a careful statistical evaluation of the study sample, unlike what happens with registries
subject information and informed consent form to participate in the study and to the processing of personal data.
The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide an adequate source of post-authorisation data for regulatory decision-making. Guidelines on how to conduct studies based on data from registries were published in 2021, with the aim of providing recommendations on key methodological aspects, specific to the use of patient registries by applicants and Marketing Authorization Holders (MAA/MAH) who intend to conduct registry-based studies.
The importance of patient registries can be attributed to the fact that epidemiological and clinical data on a given disease is often just not available, especially if the disease is not common or rare, for which scientific literature represents the only source of information, hence the interest of Italian and European institutions in general in encouraging the creation of patient registries as a tool for evaluation, surveillance, prevention and as databases of patients that can be readily enrolled in clinical trials.
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