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...

Full description

Bibliographic Details
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
Description
Summary: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.
ISSN:2229-3485