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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Clinical trials of advanced therapy investigational medicinal products in Spain: preparing for the European clinical trials regulation

Clinical Trial Designs For Advanced Therapies

Juan Estévez Álamo, Marcos Timón, Cristina González Gómez-Platero, Carmen Doadrio Abad, Marta Velasco González, María Yolanda de Mingo Ballesteros, María Ángeles Martín de la Sierra San Agustín & María Antonia Serrano Castro

Clinical trials (CT) of Advanced Therapy Medicinal Products are a reality worldwide. Although ATMPs are still very innovative therapies, it is interesting to investigate what relevant information can be obtained from the analyses of authorized CT and the investigated products. The aim of this study was to follow the evolution of CT with Advanced Therapy investigational Medicinal Products (ATiMP) authorized in Spain from May 2004 to June 2019 on the basis of information available at the Spanish Agency for Medicinal Products and Medical Devices and their real status (also taking into consideration their status in three different official Registries). We will also discuss how sponsors and Authorities can prepare for the coming new clinical trial regulation and take advantage of the opportunities it may present.

DOI: 10.18609/cgti.2019.147
Citation: Cell & Gene Therapy Insights 2019; 5(11), 1431-1449.
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