: Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the unquestionable importance of this type of studies, Italian researchers have had to face many obstacles over the years, mainly due to ambiguous definitions and to a complex but at the same time incomplete legislation. The regulatory adjustments to the European Regulation 536/2014 have further complicated the operating and operational framework, making observational research a real "Cinderella" of the Italian system.

Observational studies - The Cinderella of the Italian research system

Cagnazzo, Celeste
;
Fagioli, Franca
2023-01-01

Abstract

: Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the unquestionable importance of this type of studies, Italian researchers have had to face many obstacles over the years, mainly due to ambiguous definitions and to a complex but at the same time incomplete legislation. The regulatory adjustments to the European Regulation 536/2014 have further complicated the operating and operational framework, making observational research a real "Cinderella" of the Italian system.
2023
3008916231166469
3008916231166473
Italian research system; Observational trials; prospective studies; regulation; retrospective studies
Cagnazzo, Celeste; Basiricò, Marco; Palermo, Federica; Fagioli, Franca
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1901533
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