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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Main Author: Viraj Rajadhyaksha
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2010-01-01
Series:Perspectives in Clinical Research
Subjects:
Online Access:http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=3;spage=106;epage=109;aulast=Rajadhyaksha
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author_facet Viraj Rajadhyaksha
author_sort Viraj Rajadhyaksha
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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 doaj.art-61e991455dff4723a957cc28eac3e8a62022-12-22T03:11:28ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852010-01-0113106109Conducting feasibilities in clinical trials: An investment to ensure a good studyViraj RajadhyakshaConducting 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.http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=3;spage=106;epage=109;aulast=RajadhyakshaInvestigatorPatient recruitmentSiteProgramCountry capabilityClinical operations
spellingShingle Viraj Rajadhyaksha
Conducting feasibilities in clinical trials: An investment to ensure a good study
Perspectives in Clinical Research
Investigator
Patient recruitment
Site
Program
Country capability
Clinical operations
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 Investigator
Patient recruitment
Site
Program
Country capability
Clinical operations
url http://www.picronline.org/article.asp?issn=2229-3485;year=2010;volume=1;issue=3;spage=106;epage=109;aulast=Rajadhyaksha
work_keys_str_mv AT virajrajadhyaksha conductingfeasibilitiesinclinicaltrialsaninvestmenttoensureagoodstudy