Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017

Category: Review Article
Visits: 197 total, 2 today
Keywords: biologicals, biosimilars, monoclonal antibodies, pharmacovigilance, registries, regulation

Introduction: A registry is “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s)”. There are different types of registries, including patient, disease, product and health service. Disease or patient registries as well as product registries can offer an important mechanism of post-marketing surveillance of pharmaceuticals. As the EMA registries workshop concluded, patient registries can provide information of value to address evidence gaps in certain situations and for providing post-marketing safety and effectiveness information, from which many stakeholders can benefit. A multidisciplinary consensus on the opportunities and risks involved in setting up patient registries will help plan for the next steps in registry development.
Methods: A variety of stakeholders, including clinicians, nurses, academics, pharmacists, patient groups, regulators and industry representatives in the UK, met to discuss how registries can be set up, the role registries play in pharmacovigilance, and their use in improving research using healthcare data. Considering the impact for patients, the group discussed the issue of data safety and protection.
Results: Stakeholders agreed that patient registries, data collection at the point of care and the ability to link between registries and routine clinic and hospital data were important goals. Achieving these goals will require an aligned vision amongst stakeholders, appropriate resourcing and a sustainability model, extensive collaboration and linking across registries, and the universal implementation of standards for record headings and clinical terms.
Conclusion: The value of disease or patient registries was recognised by all stakeholders. Ongoing discussion between all parties involved is needed to work towards an aligned vision on the future of registries, the widespread adoption of national standards, more effective data linkage, improved funding and greater utility. However, the UK needs a strategic plan and champion for registries, and this should be considered by the NHS and the Health Departments across all four nations. Stakeholders currently working on registries must remain alert to future developments so that the data captured today remains of value to patients treated tomorrow and in the years to come.

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