Distinguishing between exploratory and confirmatory preclinical research will improve translation.

Preclinical researchers confront two overarching agendas related to drug development: selecting interventions amid a vast field of candidates, and producing rigorous evidence of clinical promise for a small number of interventions. We suggest that each challenge is best met by two different, complem...

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Autores principales:	Jonathan Kimmelman, Jeffrey S Mogil, Ulrich Dirnagl
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2014
Materias:	Biology (General) QH301-705.5
Acceso en línea:	https://doaj.org/article/835d26b2650a48708202d848d2b3fd7d
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spelling	oai:doaj.org-article:835d26b2650a48708202d848d2b3fd7d2021-11-11T05:37:10ZDistinguishing between exploratory and confirmatory preclinical research will improve translation.1544-91731545-788510.1371/journal.pbio.1001863https://doaj.org/article/835d26b2650a48708202d848d2b3fd7d2014-05-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24844265/?tool=EBIhttps://doaj.org/toc/1544-9173https://doaj.org/toc/1545-7885Preclinical researchers confront two overarching agendas related to drug development: selecting interventions amid a vast field of candidates, and producing rigorous evidence of clinical promise for a small number of interventions. We suggest that each challenge is best met by two different, complementary modes of investigation. In the first (exploratory investigation), researchers should aim at generating robust pathophysiological theories of disease. In the second (confirmatory investigation), researchers should aim at demonstrating strong and reproducible treatment effects in relevant animal models. Each mode entails different study designs, confronts different validity threats, and supports different kinds of inferences. Research policies should seek to disentangle the two modes and leverage their complementarity. In particular, policies should discourage the common use of exploratory studies to support confirmatory inferences, promote a greater volume of confirmatory investigation, and customize design and reporting guidelines for each mode.Jonathan KimmelmanJeffrey S MogilUlrich DirnaglPublic Library of Science (PLoS)articleBiology (General)QH301-705.5ENPLoS Biology, Vol 12, Iss 5, p e1001863 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Biology (General) QH301-705.5
spellingShingle	Biology (General) QH301-705.5 Jonathan Kimmelman Jeffrey S Mogil Ulrich Dirnagl Distinguishing between exploratory and confirmatory preclinical research will improve translation.
description	Preclinical researchers confront two overarching agendas related to drug development: selecting interventions amid a vast field of candidates, and producing rigorous evidence of clinical promise for a small number of interventions. We suggest that each challenge is best met by two different, complementary modes of investigation. In the first (exploratory investigation), researchers should aim at generating robust pathophysiological theories of disease. In the second (confirmatory investigation), researchers should aim at demonstrating strong and reproducible treatment effects in relevant animal models. Each mode entails different study designs, confronts different validity threats, and supports different kinds of inferences. Research policies should seek to disentangle the two modes and leverage their complementarity. In particular, policies should discourage the common use of exploratory studies to support confirmatory inferences, promote a greater volume of confirmatory investigation, and customize design and reporting guidelines for each mode.
format	article
author	Jonathan Kimmelman Jeffrey S Mogil Ulrich Dirnagl
author_facet	Jonathan Kimmelman Jeffrey S Mogil Ulrich Dirnagl
author_sort	Jonathan Kimmelman
title	Distinguishing between exploratory and confirmatory preclinical research will improve translation.
title_short	Distinguishing between exploratory and confirmatory preclinical research will improve translation.
title_full	Distinguishing between exploratory and confirmatory preclinical research will improve translation.
title_fullStr	Distinguishing between exploratory and confirmatory preclinical research will improve translation.
title_full_unstemmed	Distinguishing between exploratory and confirmatory preclinical research will improve translation.
title_sort	distinguishing between exploratory and confirmatory preclinical research will improve translation.
publisher	Public Library of Science (PLoS)
publishDate	2014
url	https://doaj.org/article/835d26b2650a48708202d848d2b3fd7d
work_keys_str_mv	AT jonathankimmelman distinguishingbetweenexploratoryandconfirmatorypreclinicalresearchwillimprovetranslation AT jeffreysmogil distinguishingbetweenexploratoryandconfirmatorypreclinicalresearchwillimprovetranslation AT ulrichdirnagl distinguishingbetweenexploratoryandconfirmatorypreclinicalresearchwillimprovetranslation
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Distinguishing between exploratory and confirmatory preclinical research will improve translation.

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