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408 Quality by Design: A Framework for Study Success
OBJECTIVES/GOALS: The SC CTSI Quality by Design (QbD) program aims to improve the execution of clinical research studies identifying and addressing possible issues before implementation. The program’s overall goal is to optimize operational design to achieve an 80% on-time completion rate. METHODS/S...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10129776/ http://dx.doi.org/10.1017/cts.2023.442 |
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author | Orechwa, Allison Watson-Faulkner, Minyan Buchanan, Thomas |
author_facet | Orechwa, Allison Watson-Faulkner, Minyan Buchanan, Thomas |
author_sort | Orechwa, Allison |
collection | PubMed |
description | OBJECTIVES/GOALS: The SC CTSI Quality by Design (QbD) program aims to improve the execution of clinical research studies identifying and addressing possible issues before implementation. The program’s overall goal is to optimize operational design to achieve an 80% on-time completion rate. METHODS/STUDY POPULATION: Adapted from the Clinical Trials Transformation Initiative, our QbD program applies principles of quality management, project management, and team science to SC CTSI-funded studies. The process begins with a Design Studio for systematic review of critical-to-quality factors and a discussion of risks and mitigation plans. Studio attendees generally include the research team, SC CTSI faculty, and at least one community member. Outcomes include mitigation plans, a study project plan, and continued support from the project-tailored advisory board. We will iteratively evaluate satisfaction, quality improvement, and study completion rates. RESULTS/ANTICIPATED RESULTS: In an evaluation of the pilot phase, QbD participants responded that careful planning and expert input added value to their studies. The QbD process improved the quality of their studies, and all participants plan to apply QbD tools and resources to future studies. Beyond quality improvement, other anticipated outcomes include higher on-time study completion rates and uptake of QbD resources by other research teams. We also plan to assess the comparative benefit of QbD by study type. DISCUSSION/SIGNIFICANCE: Broader application of the CTSI QbD program has the potential for widespread benefit on research processes and outcomes. Studies implemented with minimal avoidable errors are more likely to complete on time, helping ensure efficient use of valuable resources and participant time. |
format | Online Article Text |
id | pubmed-10129776 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-101297762023-04-26 408 Quality by Design: A Framework for Study Success Orechwa, Allison Watson-Faulkner, Minyan Buchanan, Thomas J Clin Transl Sci Research Management, Operations, and Administration OBJECTIVES/GOALS: The SC CTSI Quality by Design (QbD) program aims to improve the execution of clinical research studies identifying and addressing possible issues before implementation. The program’s overall goal is to optimize operational design to achieve an 80% on-time completion rate. METHODS/STUDY POPULATION: Adapted from the Clinical Trials Transformation Initiative, our QbD program applies principles of quality management, project management, and team science to SC CTSI-funded studies. The process begins with a Design Studio for systematic review of critical-to-quality factors and a discussion of risks and mitigation plans. Studio attendees generally include the research team, SC CTSI faculty, and at least one community member. Outcomes include mitigation plans, a study project plan, and continued support from the project-tailored advisory board. We will iteratively evaluate satisfaction, quality improvement, and study completion rates. RESULTS/ANTICIPATED RESULTS: In an evaluation of the pilot phase, QbD participants responded that careful planning and expert input added value to their studies. The QbD process improved the quality of their studies, and all participants plan to apply QbD tools and resources to future studies. Beyond quality improvement, other anticipated outcomes include higher on-time study completion rates and uptake of QbD resources by other research teams. We also plan to assess the comparative benefit of QbD by study type. DISCUSSION/SIGNIFICANCE: Broader application of the CTSI QbD program has the potential for widespread benefit on research processes and outcomes. Studies implemented with minimal avoidable errors are more likely to complete on time, helping ensure efficient use of valuable resources and participant time. Cambridge University Press 2023-04-24 /pmc/articles/PMC10129776/ http://dx.doi.org/10.1017/cts.2023.442 Text en © The Association for Clinical and Translational Science 2023 https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work. |
spellingShingle | Research Management, Operations, and Administration Orechwa, Allison Watson-Faulkner, Minyan Buchanan, Thomas 408 Quality by Design: A Framework for Study Success |
title | 408 Quality by Design: A Framework for Study Success |
title_full | 408 Quality by Design: A Framework for Study Success |
title_fullStr | 408 Quality by Design: A Framework for Study Success |
title_full_unstemmed | 408 Quality by Design: A Framework for Study Success |
title_short | 408 Quality by Design: A Framework for Study Success |
title_sort | 408 quality by design: a framework for study success |
topic | Research Management, Operations, and Administration |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10129776/ http://dx.doi.org/10.1017/cts.2023.442 |
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