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Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial
Advances in genomic technologies and an increased understanding of the molecular pathogenesis of cancer have resulted in development of new effective, mutation-targeted therapies. In turn, these informed the development of Master Trial designs to test these therapies. The Beat Acute Myeloid Leukemia...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332589/ https://www.ncbi.nlm.nih.gov/pubmed/33997942 http://dx.doi.org/10.1007/s43441-021-00277-w |
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author | Rosenberg, Len Levaux, Hugh Levine, Ross L. Shah, Amit Denmark, James Hereema, Nyla Owen, Melanie Kalk, Spencer Kenny, Nicholas Vinson, Gene Vergilio, Jo-Anne Mims, Alice Borate, Uma Blum, William Stein, Eytan Gana, Theophilus J. Stefanos, Mona Yocum, Ashley Marcus, Sonja Shoben, Abigail Druker, Brian Byrd, John Burd, Amy |
author_facet | Rosenberg, Len Levaux, Hugh Levine, Ross L. Shah, Amit Denmark, James Hereema, Nyla Owen, Melanie Kalk, Spencer Kenny, Nicholas Vinson, Gene Vergilio, Jo-Anne Mims, Alice Borate, Uma Blum, William Stein, Eytan Gana, Theophilus J. Stefanos, Mona Yocum, Ashley Marcus, Sonja Shoben, Abigail Druker, Brian Byrd, John Burd, Amy |
author_sort | Rosenberg, Len |
collection | PubMed |
description | Advances in genomic technologies and an increased understanding of the molecular pathogenesis of cancer have resulted in development of new effective, mutation-targeted therapies. In turn, these informed the development of Master Trial designs to test these therapies. The Beat Acute Myeloid Leukemia (BAML) Master Trial (Sponsor: The Leukemia & Lymphoma Society) tests several targeted therapies in patients aged ≥ 60 years with AML based on genomic profiling obtained within 7 days of study enrollment. We hypothesized that integrating operational strategies with new electronic technologies (e-technologies) might streamline the conduct and management of this Master Trial. BAML’s 5 core operational strategies revolve around the guiding principle of “patients first.” The e-technology platforms employed in BAML include: Clinical Oversight Platform: a central collaborative tool; e-Protocol/e-Source Upload/Electronic Data Capture Platform: digitizes the protocol, allows remote data monitoring, and collects/exports data in Study Data Tabulation Model format; and Data Review Platform: ingests data from different sources for clinical response and safety data reviews. The operational approaches, e-technologies and sponsor/contract research organization’s (CRO) expertise together allow: the complexity and size of the BAML Master Trial to be better managed; near real-time study data oversight; better collaboration, communication and training; improved data collection, enhanced transmission and accessibility; data integration, review and generation of reports; while maintaining data privacy, and compliance. Initial e-technology challenges were overcome through training, learning, discipline and adjustment. In conclusion, to successfully manage Master Trials, significant time should be spent re-evaluating, improving and developing new operational approaches. Clinical Trial Registration: Clinical Trials.gov Identifier: NCT03013998. https://clinicaltrials.gov/ct2/show/NCT03013998. |
format | Online Article Text |
id | pubmed-8332589 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-83325892021-08-20 Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial Rosenberg, Len Levaux, Hugh Levine, Ross L. Shah, Amit Denmark, James Hereema, Nyla Owen, Melanie Kalk, Spencer Kenny, Nicholas Vinson, Gene Vergilio, Jo-Anne Mims, Alice Borate, Uma Blum, William Stein, Eytan Gana, Theophilus J. Stefanos, Mona Yocum, Ashley Marcus, Sonja Shoben, Abigail Druker, Brian Byrd, John Burd, Amy Ther Innov Regul Sci Original Research Advances in genomic technologies and an increased understanding of the molecular pathogenesis of cancer have resulted in development of new effective, mutation-targeted therapies. In turn, these informed the development of Master Trial designs to test these therapies. The Beat Acute Myeloid Leukemia (BAML) Master Trial (Sponsor: The Leukemia & Lymphoma Society) tests several targeted therapies in patients aged ≥ 60 years with AML based on genomic profiling obtained within 7 days of study enrollment. We hypothesized that integrating operational strategies with new electronic technologies (e-technologies) might streamline the conduct and management of this Master Trial. BAML’s 5 core operational strategies revolve around the guiding principle of “patients first.” The e-technology platforms employed in BAML include: Clinical Oversight Platform: a central collaborative tool; e-Protocol/e-Source Upload/Electronic Data Capture Platform: digitizes the protocol, allows remote data monitoring, and collects/exports data in Study Data Tabulation Model format; and Data Review Platform: ingests data from different sources for clinical response and safety data reviews. The operational approaches, e-technologies and sponsor/contract research organization’s (CRO) expertise together allow: the complexity and size of the BAML Master Trial to be better managed; near real-time study data oversight; better collaboration, communication and training; improved data collection, enhanced transmission and accessibility; data integration, review and generation of reports; while maintaining data privacy, and compliance. Initial e-technology challenges were overcome through training, learning, discipline and adjustment. In conclusion, to successfully manage Master Trials, significant time should be spent re-evaluating, improving and developing new operational approaches. Clinical Trial Registration: Clinical Trials.gov Identifier: NCT03013998. https://clinicaltrials.gov/ct2/show/NCT03013998. Springer International Publishing 2021-05-16 2021 /pmc/articles/PMC8332589/ /pubmed/33997942 http://dx.doi.org/10.1007/s43441-021-00277-w Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Research Rosenberg, Len Levaux, Hugh Levine, Ross L. Shah, Amit Denmark, James Hereema, Nyla Owen, Melanie Kalk, Spencer Kenny, Nicholas Vinson, Gene Vergilio, Jo-Anne Mims, Alice Borate, Uma Blum, William Stein, Eytan Gana, Theophilus J. Stefanos, Mona Yocum, Ashley Marcus, Sonja Shoben, Abigail Druker, Brian Byrd, John Burd, Amy Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial |
title | Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial |
title_full | Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial |
title_fullStr | Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial |
title_full_unstemmed | Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial |
title_short | Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial |
title_sort | streamlined operational approaches and use of e-technologies in clinical trials: beat acute myeloid leukemia master trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332589/ https://www.ncbi.nlm.nih.gov/pubmed/33997942 http://dx.doi.org/10.1007/s43441-021-00277-w |
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