Factors associated with acceleration of clinical development for infectious diseases: a cross-sectional analysis of 10-year EMA registration data.

Autor:	de Jong HK; Amsterdam UMC, Location University of Amsterdam, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, the Netherlands., Hermans SM; Amsterdam UMC, Location University of Amsterdam, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, the Netherlands.; Amsterdam UMC, Location University of Amsterdam, Department of Global Health, Amsterdam Institute for Global Health and Development, Amsterdam, the Netherlands., Schuitenmaker SM; Amsterdam UMC, Location University of Amsterdam, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, the Netherlands., Oli M; Amsterdam UMC, Location University of Amsterdam, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, the Netherlands., van den Hoven MA; Amsterdam UMC, Location VU University Amsterdam, Department of Ethics, Law and Humanities, Amsterdam, the Netherlands., Grobusch MP; Amsterdam UMC, Location University of Amsterdam, Center for Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam Public Health - Global Health, and Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, the Netherlands.; Institute of Tropical Medicine, German Centre for Infection Research (DZIF), University of Tübingen, Tübingen, Germany.; Centre de Recherches Médicales en Lambaréné (CERMEL), Lambaréné, Gabon.; Masanga Medical Research Unit (MMRU), Masanga, Sierra Leone.; Institute of Infectious Diseases and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa.
Jazyk:	angličtina
Zdroj:	The Lancet regional health. Europe [Lancet Reg Health Eur] 2024 Jun 24; Vol. 43, pp. 100983. Date of Electronic Publication: 2024 Jun 24 (Print Publication: 2024).
DOI:	10.1016/j.lanepe.2024.100983
Abstrakt:	Background: Clinical trials feature centrally in the development of drugs and vaccines to determine safety and efficacy. Clinical development can be slow and may have a duration of more than ten years. Global public health threats such as Ebola virus disease (EVD) and COVID-19 have demonstrated that it is possible to accelerate clinical trials while maintaining safety and efficacy. We investigated acceleration in clinical trials over the past decade and identified factors associated with acceleration for drugs targeting infectious diseases. Methods: A cross-sectional study was performed of all medicinal compounds targeting infectious diseases that received marketing authorisation by the European Medicines Agency (EMA) between 2012 and 2022. We calculated median clinical development time in years between the first phase 1 trial enrolment date and the authorisation date. Multivariable linear regression analysis was performed to identify factors associated with shorter development times. Findings: Eighty-one trajectories were included. The median clinical development time was 7.3 years (IQR 4.4-12.3). The fastest times belonged to drugs and vaccines targeting COVID-19 (1.3 years, IQR 0.8-1.6), EVD (5.5 years, IQR 5.1-5.8), and Hepatitis A-E (5.5 years, IQR 3.9-8.2). Factors associated with shorter development times were outbreak setting (-5.4 years [95% CI, -8.2 to -2.6]), accelerated assessment status (-4.0 years [95% CI, -7.6 to -0.5]), and drugs with combined compounds (-2.7 years [95% CI, -4.9 to -0.4]). Interpretation: Clinical development time for infectious disease-related drugs and vaccines was relatively short, and outbreak setting and accelerated EMA assessment were associated with shorter development times. Funding: Amsterdam Public Health research institute. Competing Interests: None declared. (© 2024 The Author(s).)
Databáze:	MEDLINE
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