This commentary introduces a new clinical trial construct, the Master Observational Trial (MOT), which hybridizes the power of molecularly based master interventional protocols with the breadth of real-world data.
Real-World Data (RWD) can be defined as any information that helps advance patient-care from sources other than traditional clinical trials.
Analysis of these data generates Real-World Evidence (RWE) that, in turn, can generate meaningful insights into clinical care and reimbursement decision-making. The hope is that RWD, because of its plentiful nature, can be used to fill knowledge gaps that exist between the limited number of patients in clinical trial scenarios and the vast number of patients in the actual practice of medicine.
In order to fill said gap, authors in a new commentary published in @CellCellPress (2020) propose a new class of protocols - The Master Observational Trial.
Much of current retrospective RWD efforts are not of high enough quality to answer the complexities of current clinical-care. The MOT approach is an amalgamation of interventional trials and prospective observational trials, with a precise method of cataloging data.
An potential new vehicle to unlock and harness the power of RWD.