PROCRIN
Program for Clinical Research Infrastructure
Supported by the Lundbeck Foundation and the Novo Nordisk Foundation
Regionernes nationale databasedag
8. april 2015
Fremtidig forskningsstrategi for databaserne belyst ved PROCRIN
v. Jørgen Jørgensen, programleder for PROCRIN
Program for Clinical Research Infrastructure
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Maj 2012 Lundbeckfondens initiativ
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Task force
Erik Juhl
Mikael Rørth
Henrik Kehlet
Niels Borregaard
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Birgitte Nauntofte
Nina Espegård Hassel
Anne Marie Engell
Henrik Toft Sørensen
Baggrund for initiativet
1.
Der er en klar sammenhæng mellem forskning
og kvalitet i sundhedsvæsenet.
2.
Eksisterende data anvendes ikke i samme
omfang til klinisk forskning som til
epidemiologisk forskning.
3.
Det er vanskeligt for klinikere at få overblik over
data.
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Baggrund for initiativet
4.
Det er vanskeligt for klinikere at få adgang til og få
analyseret data til at besvare kliniske spørgsmål.
5.
Der mangler centrale data i en række databaser for
at de kan udnyttes optimalt i klinisk forskning.
6.
Bedre kliniske data vil styrke mulighederne for de
danske biobanker.
7.
Der er kun begrænset forskningsaktivitet indenfor
de kliniske kvalitetsdatabaser.
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Baggrund for initiativet
8.
Der er bekymring for datakvaliteten, specielt i
Landspatientregisteret og udvalgte kliniske databaser.
9.
Der anvendes ingen anerkendte definitioner af en
række kliniske variable på tværs af registre og
databaser.
10.
Der er betydeligt potentiale for dansk klinisk forskning
– almen praksis databasen og de kliniske
kvalitetsdatabaser dækker den kliniske hverdag.
11.
Danmark er ved at blive hægtet af den internationale
udvikling indenfor e-health.
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Program for Clinical Research Infrastructure
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Mål og vision
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The overarching aim of PROCRIN is to bridge
research and clinical practice.
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The program’s ambitious vision is to support the
long-term effort to ensure that all data related to
a person throughout the entire health care
system are collected systematically, undergo
quality assurance, and are available for research
and clinical purposes, while protecting the
confidentiality of individuals.
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From better data to improved health care
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Projektgruppen
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Organisation
Per Okkels, departementschef (formand), SUM
Peter Sloth, kontorchef, FIVU
Erik Jylling, sundhedspolitisk direktør, DR
Janus Laust Thomsen, direktør, DAK-E
Peter Schwarz, formand, LVS
Prof. Anders Ekbom, Karolinska Instituttet
Prof. Liam Smeeth, LSHTM
Prof. Clement McDonald, NIH
XX, Danmark
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PROCRINs delprogrammer
PROCRIN består af 5 delprogrammer som sammen
skal sikre:
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Data af høj kvalitet (Delprogram 1-3)
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Ekspertise (Delprogram 4)
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Innovation og kommunikation (Delprogram 5)
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Delprogram 1
General practice research program
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Perform standardized documentation of existing data in
the four clinical quality databases in general practice
Develop an infrastructure that facilitates completion of
prospective clinical research studies in general practice
based on voluntariness from patients and GP’s
Perform documentation of the National Health Service
Register regarding key health services provided by GPs
Programleder: Mogens Vestergaard
Daglig leder: Bodil Hammer-Bech
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Delprogram 2
Clinical quality databases
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Creation of a data infrastructure containing
information across all clinical quality databases,
standardization of data, and development of
guidelines for data collection.
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Programleder: Paul Bartels, Regionernes
Kliniske Kvalitetsudviklingsprogram (RKKP)
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Delprogram 3
National health registries
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Improvement of data completeness and data
quality in the national health registries.
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Programleder: Poul Erik Hansen, SSI
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Delprogram 4
Clinical consultancy function
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Establishment of a clinical consultancy function
covering all Danish regions, providing Danish
clinical investigators with an overview of all health
data recorded for Danish patients. The consultancy
function will assist with data access, study design,
data collection, linkage of datasets from multiple
registries, statistical analysis and reporting. The aim
is to improve data access for individual researchers,
hospitals, and universities.
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Programleder: Henrik Toft Sørensen
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Torben Jørgensen
Bente Nørgård,
Mette Nørgaard
Christian Torp-Pedersen
Henrik Toft Sørensen (leder)
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Deadlines og milestones
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Delprogram 5
PROCRIN scientific coordinating center
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Establishment of a PROCRIN scientific coordinating center to support the overall
administration of the initiative, foster cooperation and interaction among researchers
and stakeholders, provide research training and innovation, and promote Danish
clinical research in national and international efforts, in collaboration with Innovation
Centre Denmark – a Division of the Ministry of Foreign Affairs supporting innovation
and growth through partnerships with leading international academic institutions.
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Moreover, the PROCRIN scientific coordinating center will be responsible for
construction and supervision of the datasets in Subprograms 1 and 2.
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The PROCRIN scientific coordinating center will develop methods for analyzing large
datasets, allowing better definition of patient phenotypes using structured data
(demographics, diagnoses, medications, and laboratory measurements), as well as
using unstructured clinical text e.g. radiological reports and discharge summaries.
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Programleder: Henrik Toft Sørensen
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Økonomi vedr. PROCRIN
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Bevilling fra Lundbeckfonden og Novo Nordisk
Fonden i alt
for perioden 1.1.2015 – 31.12.2016:
50 millioner kroner
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Økonomi vedr. PROCRIN
Bevilling fordelt på delbudgetter
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Delprogram 1, Praksisområdet
7,0 mio. kr.
Delprogram 2, Kliniske databaser
6,6 mio. kr.
Delprogram 3, Nationale sundhedsregistre
13,0 mio. kr.
Delprogram 4, Klinisk konsulentfunktion
11,3 mio. kr.
Delprogram 5, Videnskabeligt koordinationscenter
10,7 mio. kr.
Bevillingen dækker ikke overhead til programmet. Der bidrages
således med indirekte medfinansiering fra de involverede parter.
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Fremtidig forskningsstrategi for databaserne –
med udgangspunkt i PROCRIN
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data fra kliniske kvalitetsdatabaser integreres med sundhedsdata fra andre kilder
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for at gøre en sådan integration meningsfuld skal der foretages begrebsafklaring og
teknisk harmonisering - dvs standardisering
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strategien muliggør en bredere tilgang til forskningen end forskning baseret på
enkelte datakilder
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PROCRIN investerer i forbedret validering af data
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PROCRIN investerer i uddannelse i databaseforskning og metodeudvikling
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PROCRIN’s konsulentfunktion muliggør en udvidelse af kredsen af klinikere, der
forsker
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PROCRIN arbejder på at smidiggøre forskernes adgang til sundhedsdata
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