Enrollment of Neonates in More Than One Clinical Trial



Davis, Jonathan M, Baer, Gerri R, Portman, Ronald, Nelson, Robert, Storari, Linda, Aranda, Jacob V, Box, Ralph, Zajicek, Anne, Klein, Agnes, Turner, Mark ORCID: 0000-0002-5299-8656
et al (show 3 more authors) (2017) Enrollment of Neonates in More Than One Clinical Trial. CLINICAL THERAPEUTICS, 39 (10). pp. 1959-1969.

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Abstract

Because the highest rates of morbidity and mortality in neonates are seen in those born at <32 weeks' gestation, this group has the most urgent need for novel therapies to improve survival and outcome. Legislative efforts in the United States and Europe have attempted to address this issue by requiring the study of drugs, biological and nutritional products, devices, and other therapies in this population through a combination of high-quality regulatory and clinical trials, quality improvement initiatives, and observational studies. Because there are relatively small numbers of very preterm neonates born each year in any 1 country or continent, and because a significant number of clinical trials are recruiting at any 1 time, a neonate may meet enrollment criteria for >1 clinical trial. Neonatal units that have the infrastructure and resources to engage in research frequently face the question of whether it is permissible to enroll a neonate in >1 trial. This article examines the pertinent scientific, ethical, regulatory, and industry issues that should be taken into account when considering enrolling neonates in multiple clinical studies.

Item Type: Article
Uncontrolled Keywords: neonate, clinical trial, co-enrollment
Depositing User: Symplectic Admin
Date Deposited: 03 Jan 2018 15:44
Last Modified: 19 Jan 2023 06:46
DOI: 10.1016/j.clinthera.2017.09.006
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3015328