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Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study

Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environm...

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Autor principal: Rajadhyaksha, Viraj
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications Pvt Ltd 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146075/
https://www.ncbi.nlm.nih.gov/pubmed/21814631
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author Rajadhyaksha, Viraj
author_facet Rajadhyaksha, Viraj
author_sort Rajadhyaksha, Viraj
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description Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.
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spelling pubmed-31460752011-08-03 Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study Rajadhyaksha, Viraj Perspect Clin Res Research Sites Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative. Medknow Publications Pvt Ltd 2010 /pmc/articles/PMC3146075/ /pubmed/21814631 Text en Copyright: © Perspectives in Clinical 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-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Sites
Rajadhyaksha, Viraj
Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study
title Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study
title_full Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study
title_fullStr Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study
title_full_unstemmed Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study
title_short Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study
title_sort conducting feasibilities in clinical trials: an investment to ensure a good study
topic Research Sites
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146075/
https://www.ncbi.nlm.nih.gov/pubmed/21814631
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