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Optimization of protocol design: a path to efficient, lower cost clinical trial execution

Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials’ outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol compl...

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Autor principal: Malikova, Marina A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Science Ltd 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137936/
https://www.ncbi.nlm.nih.gov/pubmed/28031939
http://dx.doi.org/10.4155/fso.15.89
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author Malikova, Marina A
author_facet Malikova, Marina A
author_sort Malikova, Marina A
collection PubMed
description Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials’ outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model. Key factors to consider when developing protocols and techniques to minimize complexity will be discussed. A methodology to identify processes at planning phase, approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials will be addressed.
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spelling pubmed-51379362016-12-28 Optimization of protocol design: a path to efficient, lower cost clinical trial execution Malikova, Marina A Future Sci OA Clinical Trial Perspective Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials’ outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model. Key factors to consider when developing protocols and techniques to minimize complexity will be discussed. A methodology to identify processes at planning phase, approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials will be addressed. Future Science Ltd 2016-01-12 /pmc/articles/PMC5137936/ /pubmed/28031939 http://dx.doi.org/10.4155/fso.15.89 Text en © Marina Malikova This work is licensed under a Creative Commons Attribution 4.0 License (http://creativecommons.org/licenses/by/4.0/)
spellingShingle Clinical Trial Perspective
Malikova, Marina A
Optimization of protocol design: a path to efficient, lower cost clinical trial execution
title Optimization of protocol design: a path to efficient, lower cost clinical trial execution
title_full Optimization of protocol design: a path to efficient, lower cost clinical trial execution
title_fullStr Optimization of protocol design: a path to efficient, lower cost clinical trial execution
title_full_unstemmed Optimization of protocol design: a path to efficient, lower cost clinical trial execution
title_short Optimization of protocol design: a path to efficient, lower cost clinical trial execution
title_sort optimization of protocol design: a path to efficient, lower cost clinical trial execution
topic Clinical Trial Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137936/
https://www.ncbi.nlm.nih.gov/pubmed/28031939
http://dx.doi.org/10.4155/fso.15.89
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