Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial. Academic Article uri icon

Overview

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 .

authors

  • 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

publication date

  • May 16, 2021

Research

keywords

  • Leukemia, Myeloid, Acute

Identity

PubMed Central ID

  • PMC8332589

Scopus Document Identifier

  • 85106225766

Digital Object Identifier (DOI)

  • 10.1007/s43441-021-00277-w

PubMed ID

  • 33997942

Additional Document Info

volume

  • 55

issue

  • 5