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Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial
- Source :
- Therapeutic Innovation & Regulatory Science
- Publication Year :
- 2021
- Publisher :
- Springer International Publishing, 2021.
-
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.
- Subjects :
- 0301 basic medicine
E-technologies
Information privacy
Artificial intelligence
Technology
Process management
Electronic data capture
Computer science
computer.software_genre
03 medical and health sciences
Upload
0302 clinical medicine
Clinical trials
Humans
Pharmacology (medical)
Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Original Research
Protocol (science)
Clinical Trials as Topic
Data collection
Public Health, Environmental and Occupational Health
Clinical trial
Leukemia, Myeloid, Acute
030104 developmental biology
Remote monitoring
Contract research organization
030220 oncology & carcinogenesis
EHR-to-EDC
computer
Data integration
EDC
Subjects
Details
- Language :
- English
- ISSN :
- 21684804 and 21684790
- Volume :
- 55
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Therapeutic Innovation & Regulatory Science
- Accession number :
- edsair.doi.dedup.....9d5d585451a016153d439c5f7d633fd7