Cargando…
The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study
BACKGROUND: As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite tri...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8734918/ https://www.ncbi.nlm.nih.gov/pubmed/34941552 http://dx.doi.org/10.2196/30368 |
_version_ | 1784628116730150912 |
---|---|
author | Mudaranthakam, Dinesh Pal Brown, Alexandra Kerling, Elizabeth Carlson, Susan E Valentine, Christina J Gajewski, Byron |
author_facet | Mudaranthakam, Dinesh Pal Brown, Alexandra Kerling, Elizabeth Carlson, Susan E Valentine, Christina J Gajewski, Byron |
author_sort | Mudaranthakam, Dinesh Pal |
collection | PubMed |
description | BACKGROUND: As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties. OBJECTIVE: The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management. METHODS: A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. RESULTS: Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates. CONCLUSIONS: The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj |
format | Online Article Text |
id | pubmed-8734918 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-87349182022-01-21 The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study Mudaranthakam, Dinesh Pal Brown, Alexandra Kerling, Elizabeth Carlson, Susan E Valentine, Christina J Gajewski, Byron JMIR Form Res Original Paper BACKGROUND: As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties. OBJECTIVE: The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management. METHODS: A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. RESULTS: Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates. CONCLUSIONS: The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj JMIR Publications 2021-12-22 /pmc/articles/PMC8734918/ /pubmed/34941552 http://dx.doi.org/10.2196/30368 Text en ©Dinesh Pal Mudaranthakam, Alexandra Brown, Elizabeth Kerling, Susan E Carlson, Christina J Valentine, Byron Gajewski. Originally published in JMIR Formative Research (https://formative.jmir.org), 22.12.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Mudaranthakam, Dinesh Pal Brown, Alexandra Kerling, Elizabeth Carlson, Susan E Valentine, Christina J Gajewski, Byron The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study |
title | The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study |
title_full | The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study |
title_fullStr | The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study |
title_full_unstemmed | The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study |
title_short | The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study |
title_sort | successful synchronized orchestration of an investigator-initiated multicenter trial using a clinical trial management system and team approach: design and utility study |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8734918/ https://www.ncbi.nlm.nih.gov/pubmed/34941552 http://dx.doi.org/10.2196/30368 |
work_keys_str_mv | AT mudaranthakamdineshpal thesuccessfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT brownalexandra thesuccessfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT kerlingelizabeth thesuccessfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT carlsonsusane thesuccessfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT valentinechristinaj thesuccessfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT gajewskibyron thesuccessfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT mudaranthakamdineshpal successfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT brownalexandra successfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT kerlingelizabeth successfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT carlsonsusane successfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT valentinechristinaj successfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy AT gajewskibyron successfulsynchronizedorchestrationofaninvestigatorinitiatedmulticentertrialusingaclinicaltrialmanagementsystemandteamapproachdesignandutilitystudy |