National Registriesfor Rare Diseases
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1 National Registriesfor Rare Diseases Luciano Vittozzi National Centre for Rare Diseases, National Institute of Health Rome -Italy
2 The currentsituation Registries serving 24 ERNs (to be developed) hospital-based National (institutional) Registries Different but partly overlapping aims; population-based Other purpose-specific(spontaneous) registries and databases Clinical and epidemiological research, post-marketing surveillance, public health research; hospital-based Patient registries promoted by patients for their specific information needs EU Rare Disease Platform queryingany type of registries accordingto a core data set
3 Taruscio et al: Public Health Genomics. 2015;18(1):20-5.
4 National (institutional) Registries Belgium, France, Italy, Spain, «Nordic Countries», Bulgaria, Germany Differences legalbasis (mandatory legislation/research-basis; different PDP regulations) governance (one or more amongauthorities, industry, payers, researchers, patients); case identification (de-identified, aggregated, encrypted); Aims: mainly clinical research, plus/or epidemiological and public health Similarities: rooted in the Public Health System; wide-purpose and multi-disease; quality assurance
5 Data sets of currentnational Registries for epidemiologyand PH aims limited number of non disease-specific variables; same data domains; variables and definitions broadly overlapping for clinical research Data set extended to a number of disease-specific and varied variables
6 BNDMR (slide from Landais,, presented at EPIRARE meeting, Rome 05/03/2014) Data Warehouse BNDMR SNIIRAM PMSI SAE DRESS INSEE Other sources Systems BaMaRa connectors EHR MDS connectors RaDiCo Interoperability Domains Infrastructures Epidemiology Care Research BNDMR, PNMR2, DGOS Interoperability framework Interoperability of systems and data Plan Hôpital Numérique, DGOS,DGS,ARS RaDiCo, investments for the future, INSERM, ANR BNDMR : National Data Bank for Rare Diseases; BaMaRa: Rare Diseases Database; EHR: Electronic Health Record; MDS : Minimum Data Set ; RaDiCo : Rare Disease Cohorts; SNIIRAM : Information system of the Health Care Insurance; PMSI : Activity based Payment Information System; SAE : Hospitals Annual Statistics ; DRESS : Direction for research, studies, evaluation and statistics of the Ministry of Health; INSEE : National Institute for statistics and economic studies. Source : Landais P, Choquet R, BaMaRa 2014
7 ERNsand spontaneousregistries Biomedical and clinical research ERN Care Providers Health care Clinical Trials Health Care Quality; Policiesand planning; Patient-centered information -omics platforms RD-Connect platform Selected cases; All found gene variations; HPO phenotype traits; No care data Biobanks EPIRARE platform Exhaustive collection of known cases; Relevantclinical, genetic and care data; Indicators HTA Postmarketing surveillance
8 Conclusions-1 National (institutional) Registries are a unique opportunity to Develop a reference data set supporting the production of EU indicators for RD Produce population-based data Provide sound data on mostrare RD MostCountriesare goingto developtheirnrs The current NRs provide pilot experience Thereis a strong needfor a coordinatingactionto avoidthat Countries develop independent NRs Spontaneous registries cannot contribute to international collaborations
9 Conclusions-2 To improve the collaboration and funding perspectives of your registry: Make reference to your country NR Data Set Ifno NR, refer to EPIRARE and RD-Connect data sets Complywith the EU RD Platform
10 Publications and data sets: see Thankyoufor yourattention! Luciano Vittozzi : cnmr.eu@iss.it
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