#1 HOT OFF THE PRESS @CellCellPress Introducing MASTER OBSERVATIONAL TRIAL (MOT): A NEW class of Master Protocol to Advance #PrecisionMedicine cell.com/cell/fulltext/… MOT hybridizes power of molecularly based master interventional protocols with the breadth of #realworlddata 
# 2The Master Observational Trial (MOT)-->Patients are broadly accepted into the trial along with diagnosis + staging info. Biomarker testing results (both positive and negative) are collected & classified using methods shown in Figures 1A and 1B.
# 3High-level outcomes are collected in connection with each line of therapy. All of the information is tied together in a prospective observational registry using standardized reporting methods and metrics. cell.com/cell/fulltext/…
# 4 The General Structure of a #MOT: It is a prospective, observational trial that broadly accepts patients independent of biomarker signature and collects comprehensive data on each
# 5 Transparent governance. Multi-institutional + international efforts are essential in the designing + implementing of an MOT. Leadership must transparently address cross-institutional + cross-stakeholder concerns to bring groups together.
# 6 Centralized trial administrative functions. These provide organizational consistency across institutions and include central leadership, contracting, institutional review board (IRB), training and certification, and audit.
# 7 Traditional interventional trial organization. This helps mitigate bias by standardizing as much as possible and includes a written and registered protocol, standardized case-report forms, defined reporting, and regular queries for missing or unclear data.
# 8 IRB-approved patient consent and HIPAA (or equivalent) privacy authorization.
# 9 Precise molecular testing classification. Biomarkers, both present and absent, are recorded along with temporal association with treatment, tissue location, testing laboratory, testing details, and test version
# 10 Standardized clinical data elements. The broad collection of data across multiple lines of therapy needs to have at least essential core data elements collected. Robust enough to answer multiple questions & are likely going to be substantially different for different fields.
# 11 Longitudinal data collection. By collecting key information on each phase of a patient’s journey from diagnosis to disease resolution or death, broader understanding of complex interactions can be explored.
# 12 Modular trial design (internal to protocol). Although data are observational, there needs to be a broad understanding of what types of patients should be included in the trial. cell.com/cell/fulltext/…
# 13 Seamless integration with interventional trials or RWD (external to protocol). Attaching interventional trials, including single arm, master protocol, or randomized trials, inside the MOT structure allows for the answering of specific questions about new testing or therapy.
# 14 #ArtificialIntelligence #AI & #machinelearning from multiple perspectives. MOTs will collect massive amounts of data. Will be essential in turning raw data into actionable hypotheses. cell.com/cell/fulltext/…
We need accessible, quality data on hundreds of thousands of patients, harboring the breadth of molecular alterations in order to develop scientifically rigorous analysis. cell.com/cell/fulltext/…
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