Irreproducibility –The deadly sin of preclinical research in drug development

Introduction In recent years the irreproducibility of preclinical studies has become a serious concern in drug developmental research. The findings of preclinical studies that cannot be reproduced are a drain on public resources and slow down the drug discovery process. Among the various factors tha...

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Main Authors: Sadasivan Kalathil Pillai, Katsumi Kobayashi, Mathews Michael, Meena Arumugam
Format: Article
Language:English
Published: Institute of Rural Health 2020-12-01
Series:Journal of Pre-Clinical and Clinical Research
Subjects:
Online Access:https://www.jpccr.eu/Irreproducibility-The-deadly-sin-of-preclinical-research-in-drug-development,131017,0,2.html
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author Sadasivan Kalathil Pillai
Katsumi Kobayashi
Mathews Michael
Meena Arumugam
author_facet Sadasivan Kalathil Pillai
Katsumi Kobayashi
Mathews Michael
Meena Arumugam
author_sort Sadasivan Kalathil Pillai
collection DOAJ
description Introduction In recent years the irreproducibility of preclinical studies has become a serious concern in drug developmental research. The findings of preclinical studies that cannot be reproduced are a drain on public resources and slow down the drug discovery process. Among the various factors that contribute to irreproducibility in preclinical drug developmental research, poor statistical analysis and weak experimental design play a major role in the failure of drugs in clinical research. Conclusion. Poor experimental design and lack of knowledge or limited knowledge of statistical analysis of data contribute significantly to the irreproducibility of preclinical research. A well-designed experiment with proper statistical analysis of data conducted by committed researchers rarely fails to reproduce. Objective The aim of this review is to describe key factors, such as poor statistical analysis and weak experimental design, that contribute to the irreproducibility of preclinical studies in drug development, and how such studies slow down the drug development process. Brief description of the state of knowledge Theirreproducibility of preclinical research is a serious issue that researchers, especially those who are involved in drug discovery, are facing today. The irreproducibility of research drains public resources, time, and diminish the trust of the common man in the research community. The factors that contribute to the irreproducibility of preclinical research are related to experiment design and improper statistical analysis of the experimental data. Most of these factors can be eliminated by researchers developing a commitment to science and society. Conclusions Poor experimental design and lack of knowledge or limited knowledge of statistical analysis of data contribute significantly to the irreproducibility of preclinical research. A well-designed experiment with proper statistical analysis of data conducted by committed researchers rarely fails to reproduce.
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spelling doaj.art-3cf67d6b422047818856a4c0ce6b965d2023-03-15T10:35:11ZengInstitute of Rural HealthJournal of Pre-Clinical and Clinical Research1898-23951898-75162020-12-0114416516810.26444/jpccr/131017131017Irreproducibility –The deadly sin of preclinical research in drug developmentSadasivan Kalathil Pillai0https://orcid.org/0000-0001-9498-1425Katsumi Kobayashi1https://orcid.org/0000-0002-3588-4526Mathews Michael2https://orcid.org/0000-0002-0268-7307Meena Arumugam3https://orcid.org/0000-0002-3983-8180International Institute of Biotechnology and Toxicology (IIBAT), Padappai, IndiaEx-Cabinet Secretary Researcher, Food Safety Commission of Japan, Akasaka, JapanTrichinopoly.i, Tiruchirappalli, IndiaK.K. College of Pharmacy, Chennai, IndiaIntroduction In recent years the irreproducibility of preclinical studies has become a serious concern in drug developmental research. The findings of preclinical studies that cannot be reproduced are a drain on public resources and slow down the drug discovery process. Among the various factors that contribute to irreproducibility in preclinical drug developmental research, poor statistical analysis and weak experimental design play a major role in the failure of drugs in clinical research. Conclusion. Poor experimental design and lack of knowledge or limited knowledge of statistical analysis of data contribute significantly to the irreproducibility of preclinical research. A well-designed experiment with proper statistical analysis of data conducted by committed researchers rarely fails to reproduce. Objective The aim of this review is to describe key factors, such as poor statistical analysis and weak experimental design, that contribute to the irreproducibility of preclinical studies in drug development, and how such studies slow down the drug development process. Brief description of the state of knowledge Theirreproducibility of preclinical research is a serious issue that researchers, especially those who are involved in drug discovery, are facing today. The irreproducibility of research drains public resources, time, and diminish the trust of the common man in the research community. The factors that contribute to the irreproducibility of preclinical research are related to experiment design and improper statistical analysis of the experimental data. Most of these factors can be eliminated by researchers developing a commitment to science and society. Conclusions Poor experimental design and lack of knowledge or limited knowledge of statistical analysis of data contribute significantly to the irreproducibility of preclinical research. A well-designed experiment with proper statistical analysis of data conducted by committed researchers rarely fails to reproduce.https://www.jpccr.eu/Irreproducibility-The-deadly-sin-of-preclinical-research-in-drug-development,131017,0,2.htmldata irreproducibilitypreclinical studiesp-values
spellingShingle Sadasivan Kalathil Pillai
Katsumi Kobayashi
Mathews Michael
Meena Arumugam
Irreproducibility –The deadly sin of preclinical research in drug development
Journal of Pre-Clinical and Clinical Research
data irreproducibility
preclinical studies
p-values
title Irreproducibility –The deadly sin of preclinical research in drug development
title_full Irreproducibility –The deadly sin of preclinical research in drug development
title_fullStr Irreproducibility –The deadly sin of preclinical research in drug development
title_full_unstemmed Irreproducibility –The deadly sin of preclinical research in drug development
title_short Irreproducibility –The deadly sin of preclinical research in drug development
title_sort irreproducibility the deadly sin of preclinical research in drug development
topic data irreproducibility
preclinical studies
p-values
url https://www.jpccr.eu/Irreproducibility-The-deadly-sin-of-preclinical-research-in-drug-development,131017,0,2.html
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AT meenaarumugam irreproducibilitythedeadlysinofpreclinicalresearchindrugdevelopment