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Interim analysis: A rational approach of decision making in clinical trial

Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, s...

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Detalles Bibliográficos
Autores principales: Kumar, Amal, Chakraborty, Bhaswat S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052936/
https://www.ncbi.nlm.nih.gov/pubmed/27833889
http://dx.doi.org/10.4103/2231-4040.191414
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author Kumar, Amal
Chakraborty, Bhaswat S.
author_facet Kumar, Amal
Chakraborty, Bhaswat S.
author_sort Kumar, Amal
collection PubMed
description Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.
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spelling pubmed-50529362016-11-10 Interim analysis: A rational approach of decision making in clinical trial Kumar, Amal Chakraborty, Bhaswat S. J Adv Pharm Technol Res Review Article Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals. Medknow Publications & Media Pvt Ltd 2016 /pmc/articles/PMC5052936/ /pubmed/27833889 http://dx.doi.org/10.4103/2231-4040.191414 Text en Copyright: © 2016 Journal of Advanced Pharmaceutical Technology & Research http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Review Article
Kumar, Amal
Chakraborty, Bhaswat S.
Interim analysis: A rational approach of decision making in clinical trial
title Interim analysis: A rational approach of decision making in clinical trial
title_full Interim analysis: A rational approach of decision making in clinical trial
title_fullStr Interim analysis: A rational approach of decision making in clinical trial
title_full_unstemmed Interim analysis: A rational approach of decision making in clinical trial
title_short Interim analysis: A rational approach of decision making in clinical trial
title_sort interim analysis: a rational approach of decision making in clinical trial
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052936/
https://www.ncbi.nlm.nih.gov/pubmed/27833889
http://dx.doi.org/10.4103/2231-4040.191414
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