Phase 1 clinical trials represent a critical phase of drug development because new candidate therapeutic agents are tested for the first time on humans. Therefore, international guidelines and local laws have been released to mitigate and control possible risks for human health in agreement with the declaration of Helsinki and the international Good Clinical Practice principles. Despite numerous scientific works characterizing the registered clinical trials on ClinicalTrials.gov, the main features and trends of registered phase 1 clinical trials in Europe have not been investigated. This study is aimed at assessing the features and the temporal trend of distribution of phase 1 clinical studies, carried out in the five largest European countries over a ten-year period (2012-2021), and to evaluate the impact of the Italian regulatory framework on the activation of such studies.

Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries / Di Tonno, Davide; Perlin, Caterina; Loiacono, Anna Chiara; Giordano, Luca; Martena, Laura; Lagravinese, Stefano; Rossi, Federica; Marsigliante, Santo; Maffia, Michele; Falco, Andrea; Piscitelli, Prisco; Miani, Alessandro; Esposito, Susanna; Distante, Alessandro; Argentiero, Alberto. - In: INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH. - ISSN 1660-4601. - 19:21(2022), p. 14023. [10.3390/ijerph192114023]

Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries

Esposito, Susanna;Argentiero, Alberto
2022-01-01

Abstract

Phase 1 clinical trials represent a critical phase of drug development because new candidate therapeutic agents are tested for the first time on humans. Therefore, international guidelines and local laws have been released to mitigate and control possible risks for human health in agreement with the declaration of Helsinki and the international Good Clinical Practice principles. Despite numerous scientific works characterizing the registered clinical trials on ClinicalTrials.gov, the main features and trends of registered phase 1 clinical trials in Europe have not been investigated. This study is aimed at assessing the features and the temporal trend of distribution of phase 1 clinical studies, carried out in the five largest European countries over a ten-year period (2012-2021), and to evaluate the impact of the Italian regulatory framework on the activation of such studies.
Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries / Di Tonno, Davide; Perlin, Caterina; Loiacono, Anna Chiara; Giordano, Luca; Martena, Laura; Lagravinese, Stefano; Rossi, Federica; Marsigliante, Santo; Maffia, Michele; Falco, Andrea; Piscitelli, Prisco; Miani, Alessandro; Esposito, Susanna; Distante, Alessandro; Argentiero, Alberto. - In: INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH. - ISSN 1660-4601. - 19:21(2022), p. 14023. [10.3390/ijerph192114023]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2933092
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