TY - JOUR
T1 - Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials
T2 - Beat Acute Myeloid Leukemia Master Trial
AU - Rosenberg, Len
AU - Levaux, Hugh
AU - Levine, Ross L.
AU - Shah, Amit
AU - Denmark, James
AU - Hereema, Nyla
AU - Owen, Melanie
AU - Kalk, Spencer
AU - Kenny, Nicholas
AU - Vinson, Gene
AU - Vergilio, Jo Anne
AU - Mims, Alice
AU - Borate, Uma
AU - Blum, William
AU - Stein, Eytan
AU - Gana, Theophilus J.
AU - Stefanos, Mona
AU - Yocum, Ashley
AU - Marcus, Sonja
AU - Shoben, Abigail
AU - Druker, Brian
AU - Byrd, John
AU - Burd, Amy
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
KW - Artificial intelligence
KW - Clinical trials
KW - E-technologies
KW - EDC
KW - EHR-to-EDC
KW - Remote monitoring
UR - http://www.scopus.com/inward/record.url?scp=85106225766&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85106225766&partnerID=8YFLogxK
U2 - 10.1007/s43441-021-00277-w
DO - 10.1007/s43441-021-00277-w
M3 - Article
C2 - 33997942
AN - SCOPUS:85106225766
SN - 2168-4790
VL - 55
SP - 926
EP - 935
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 5
ER -