Streamlined operational approaches and use of e-technologies in clinical trials: Beat acute myeloid leukemia master trial Journal Article
| Authors: | Rosenberg, L.; Levaux, H.; Levine, R. L.; Shah, A.; Denmark, J.; Hereema, N.; Owen, M.; Kalk, S.; Kenny, N.; Vinson, G.; Vergilio, J. A.; Mims, A.; Borate, U.; Blum, W.; Stein, E.; Gana, T. J.; Stefanos, M.; Yocum, A.; Marcus, S.; Shoben, A.; Druker, B.; Byrd, J.; Burd, A. |
| Article Title: | Streamlined operational approaches and use of e-technologies in clinical trials: Beat acute myeloid leukemia master trial |
| Abstract: | 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. © 2021, The Author(s). |
| Keywords: | artificial intelligence; clinical trials; remote monitoring; e-technologies; edc; ehr-to-edc |
| Journal Title: | Therapeutic Innovation & Regulatory Science |
| Volume: | 55 |
| Issue: | 5 |
| ISSN: | 2168-4790 |
| Publisher: | Springer |
| Date Published: | 2021-09-01 |
| Start Page: | 926 |
| End Page: | 935 |
| Language: | English |
| DOI: | 10.1007/s43441-021-00277-w |
| PUBMED: | 33997942 |
| PROVIDER: | scopus |
| PMCID: | PMC8332589 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 September 2021 -- Source: Scopus |
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