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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications & Media Pvt Ltd
2016
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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. |
format | Online Article Text |
id | pubmed-5052936 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT kumaramal interimanalysisarationalapproachofdecisionmakinginclinicaltrial AT chakrabortybhaswats interimanalysisarationalapproachofdecisionmakinginclinicaltrial |