Development of Real-Time Surveillance for Serious Adverse Events in a Pragmatic Clinical Trial Using National Registers in Finland
Safety signals can be detected and evaluated in real-time during a pragmatic vaccine trial with register-based follow-up, utilizing passive data collection and population level comparison. Compared to conventional methods of safety follow-up, this method is likely to be more comprehensive, objective and resource effective.
Authors
- Tuomo Nieminen (ORCID: https://orcid.org/0000-0002-6901-2208)
- Heta Nieminen (ORCID: https://orcid.org/0000-0003-3353-7579)
- Stéphanie Pépin (ORCID: https://orcid.org/0009-0007-6315-0996)
- Ritva Syrjänen (ORCID: https://orcid.org/0000-0002-1077-6617)
- Kari Auranen (ORCID: https://orcid.org/0000-0002-8162-2260)
- Tamala Mallett Moore (ORCID: https://orcid.org/0000-0001-9325-4779)
- Sangita Kulathinal (ORCID: https://orcid.org/0000-0002-4542-8460)
- Raija Auvinen (ORCID: https://orcid.org/0000-0003-1300-1048)
- Arto A. Palmu (ORCID: https://orcid.org/0000-0001-8071-8896)
- Jukka Jokinen
Institutions
- Statistics Finland (FI)
- University of Helsinki (FI)
- University of Turku (FI)
- Turku University of Applied Sciences (FI)
- Helsinki University Hospital (FI)
- Finnish Defence Forces (FI)
- Turku University Hospital (FI)
- Sanofi (France) (FR)
- Finnish Institute for Health and Welfare (FI)
- Sanofi (United States) (US)
- Hospital District of Helsinki and Uusimaa (FI)
Publication Details
- Journal
- Clinical Epidemiology
- Published
- 2024-12-01
- DOI
- https://doi.org/10.2147/clep.s483034
- Citations
- 1
- Primary Topic
- Influenza Virus Research Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.39
Funders
- Sanofi