Status: Ongoing First registered on: 29/06/2023
Last updated on: 02/10/2023
1. Study identification
EU PAS Register NumberEUPAS105544
Official titleUse cases for development, optimisation and implementation of artificial intelligence methods for real world data analyses in regulatory decision-making and health technology assessment along the product lifecycle
Study title acronymReal4Reg
Study typeObservational study
Brief description of the studyThe use of real world data (RWD) is established in regulatory processes such as safety monitoring, but evidentiary value for further use cases, especially in the pre-authorisation and evaluation phase of medicinal products, is rudimentary. Also, the use of RWD in post-authorisation steps is constrained by data variability and by challenges in analysing data from different settings and sources. Moreover, there are emerging opportunities in the use of artificial intelligence (AI), but there is a lack of knowledge on its appropriate application to heterogeneous RWD sources to increase evidentiary value in the regulatory decision-making and health technology assessment (HTA) context. Thus, the development of new and optimised AI-supported methodologies for RWD analyses is essential. In addition, the four use cases to be investigated in this study contain phenotype-specific open questions of high regulatory interest.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacoepidemiology Research BfArM
Department/Research groupResearch/ Pharmacoepidemiology
Organisation/affiliationBfArM
Website/Homepage
Details of (Primary) lead investigator
Title Professor
Last name Haenisch
First name Britta
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?10

Aarhus University Dept. of Clinical Epidemiology
School of Pharmacy, University of Eastern Finland, Kuopio, Finland
Danish Medicines Agency, Data Analytics Centre, Copenhagen, Denmark
National Authority of Medicines and Health Products, I.P. (Infarmed), Lisboa, Portugal
Fraunhofer Society, Fraunhofer Institute for Algorithms and Scientific Computing (SCAI), Research Group AI and Data Science, Sankt Augustin, Germany
IT Centre for Science (CSC), Espoo, Finland
German Centre for Neurodegenerative Diseases (DZNE), Research Group Pharmacoepidemiology, Bonn, Germany
European Organization for Professionals and Patients with ALS (EUpALS), Leuven, Belgium
European Institute of Women’s Health (EIWH), Dublin, Ireland
Countries in which this study is being conducted
International study

Denmark
Finland
Germany
Portugal
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed05/11/202211/11/2022
Start date of data collection01/09/202311/09/2023
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2026
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyHORIZON Europe (EMA)100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Haenisch
First name Britta
Address line 1Kurt-Georg-Kiesinger-Alle 3
Address line 2 
Address line 3 
CityBonn 
Postcode53175 
CountryGermany
Phone number (incl. country code)49228993075721 
Alternative phone number 
Fax number (incl. country code) 
Email address britta.haenisch@bfarm.de
Public Enquiries
Title Ms 
Last name Fernandes 
First name Joana 
Address line 1Parque da Saúde de Lisboa, Avenida do Brasil, 53 
Address line 2 
Address line 3 
CityLisboa 
Postcode1749-004 
CountryPortugal 
Phone number (incl. country code)351217987167 
Alternative phone number 
Fax number (incl. country code) 
Email address real4reg@infarmed.pt 
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