https://catalogues.ema.europa.eu/node/3141/methodological-aspects
First published
24/11/2021Last updated
23/04/2024
EU PAS number:
EUPAS44229
Study
Finalised
Secondary tabs
Administrative detailsMethodological aspectsData managementStudy identification
PURI
EU PAS number
EUPAS44229
Study ID
47485
Official title and acronym
Benefit Risk contextualisation of COVID-19 vaccines in the EU
DARWIN EU® study
No
Study countries
Belgium
Study description
The Belgian CenStat/I-BioStat team is delighted to contribute to EMA’s important task to monitor important benefits and safety signals of COVID-19 vaccines by addressing three specific objectives. The first objective is to propose a valid method to quantify both the benefits and the risks related to COVID-19 vaccines given potential data limitations and reflecting uncertainty with regard to the various ingredients of the proposed risk-benefit measure. The second objective is to explore the possibility of developing composite measure The third objective is to provide a toolkit to support the calculations and interpretation of the various outcomes.
Study status
Finalised
Contact details
Geert Molenberghs
Study contact
Geert Molenberghs
Primary lead investigatorStudy timelines
Date when funding contract was signed
Planned:
27/07/2021
Actual:
27/07/2021
Study start date
Planned:
04/08/2021
Actual:
04/08/2021
Date of final study report
Planned:
25/04/2022
Actual:
25/05/2022Sources of funding
EMAStudy protocol
Initial protocol
COVID 19 risk benefit analysis for EMA- study protocol
English (484.14 KB – PDF)View document
Updated protocol
Study protocol EUPAS44229
English (486.36 KB – PDF)View documentRegulatory
Was the study required by a regulatory body?
Yes
Is the study required by a Risk Management Plan (RMP)?
Not applicable
FINAL STUDY REPORT
Title:
Reference: ROC23 under FWA EMA/2017/09/PE (Lot1) Deliverable 4 v2 20042022
Benefit Risk contextualisation of COVID-19 vaccines in the EU
To:
European Medicines Agency (EMA) Amsterdam, The Netherlands
Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone Acetate/Ethinylestradiol and Levonorgestrel/Ethinylestradiol (RIVET-RCS)
First published
14/04/2016Last updated
27/05/2024
EU PAS number:
EUPAS12171
Study
Ongoing
Secondary tabs
Administrative detailsMethodological aspectsData managementStudy identification
PURI
EU PAS number
EUPAS12171
Study ID
46024
Official title and acronym
Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone Acetate/Ethinylestradiol and Levonorgestrel/Ethinylestradiol (RIVET-RCS)
DARWIN EU® study
No
Study countries
Germany
Study description
Rationale and background: The risk of venous thromboembolism (VTE) associated with the use of chlormadinoe acetate (CMA) is currently unknown as the available data have significant limitations and lack data on direct comparison between levonorgestrel- (LNG) and CMA-containing combined oral contraceptives (COCs). Study design: this is a retrospective cohort study and will be conducted as substitute for the RIVET-Case Control study, which was discontinued due to slow recruitment of both cases and controls. Following several attempts to enhance the recruitment in RIVET-CC, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended a pooled analysis of 4 prospective cohort studies in order to clarify whether CMA/EE-containing COCs carry a different VTE risk compared to LNG/EE-containing COCs. Participants will be identified retrospectively from a pooled dataset which comprises four large, controlled, prospective, non-interventional active surveillance studies that focused on the risk of VTE associated with the use of combined oral contraceptives (LASS/EURAS-OC, INAS-OC, INAS-SCORE, INAS-FOCUS). All data were prospectively collected by ZEG Berlin and follow the EURAS/INAS study design. Inclusion and exclusion criteria, the method of patient recruitment and follow-up as well as research methods were similar across studies. Gedeon Richter and its Collaborators requested this Study in agreement with the competent European regulatory authority and supports it by an unconditional grant to ZEG. Gedeon Richter and its Collaborators are not actively involved in the conduct of the Study.
Study status
OngoingResearch institution and networks
Institutions
Berlin Center for Epidemiology & Health Research, ZEG Berlin
Germany
First published:
06/08/2019Last updated
27/05/2024
Institution
Laboratory/Research/Testing facilityENCePP partner
Contact details
Pauline De Corte
Study contact
Klaas Heinemann
Primary lead investigatorStudy timelines
Date when funding contract was signed
Planned:
21/07/2021
Actual:
09/05/2016
Study start date
Planned:
26/06/2009
Actual:
27/06/2016
Data analysis start date
Planned:
21/03/2022
Date of final study report
Planned:
30/09/2021Sources of funding
Pharmaceutical company and other private sector
More details on funding
Aristo Pharma,Dr.Kade,Gynial,Hormosan Pharma,Jenapharm,Kwizda Pharma,Meda Pharma,Mibe,Acis,Dermapharm,Sun-Farm,Mithra,Mylan,Gedeon Richter,Pfizer Austria,STADA,WH-Pharma,Zentiva Ph,Actavis,ITF Farmahealth,Sandoz,1APharma,Hexal,HeatonRegulatory
Was the study required by a regulatory body?
Yes
Is the study required by a Risk Management Plan (RMP)?
EU RMP category 1 (imposed as condition of marketing authorisation)
JULIMINATION 
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