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.
Highlights
Advances in genomic technologies and in our understanding of cancer genetics has led to an explosion of targeted therapies and there is growing evidence that patients benefit from this paradigm shift, often termed as personalized medicine [1,2,3]
This paper reports the use of e-technologies in the design and implementation of master protocol (MP) in cancer clinical trials, the Beat Acute Myeloid Leukemia (BAML) Master Trial, the guiding principles, operational strategies, potential advantages, and the challenges we encountered with our resultant solutions
The Clinical Oversight Platform (COP), a central communication/collaborative tool allows the complexity and size of the trial to be better managed while optimizing oversight; e-Protocol and electronic-Learning Management System (e-LMS) allow paper protocols to be digitized within days and centralized protocol training, respectively, saving weeks of training per protocol; e-Source upload (e-SU) uploads certified copies of unredacted source documents allowing remote data monitoring; the EDC captures and exports data in real-time in analysis- and submission-ready Standard Data Tabulation Model (SDTM), and allows rapid e-CRF changes in hours post-amendments; EHR-to-EDC markedly reduces data entry at the sites and with no transcription errors, reduces the number of queries received at the site; and the Data review platform (DRP) integrates data from different sources with consistent formats for review and generation of reports
Summary
Advances in genomic technologies and in our understanding of cancer genetics has led to an explosion of targeted therapies and there is growing evidence that patients benefit from this paradigm shift, often termed as personalized medicine [1,2,3]. The combination of the e-Protocol/e-SU/ EDC platform, DRP and technologically savvy data operations experts at the CRO, allows BAML to have centralized sponsor oversight and control over the entire data collection process These innovative technology solutions help the sites perform their activities closer to actual visit dates, allows for near real-time clinical and safety data oversight, and facilitates interim data analyses and regulatory submissions. BAML has begun partnering with a data analysis technology company, to develop new Key Risk Indicators (KRIs) for genomically based, complex Master Trials within each sub-study and across substudies With this approach, we are leveraging APIs and other automated integration points to seamlessly pull the data from the various sub-studies and technology solutions (EDC, clinical trial management system, labs, etc.), process them via a centralized risk algorithm, and present KRIs and other data visualizations for program management. The first version of the KRI dashboard was successfully delivered in July 2019
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