As defined by the FDA, a master protocol is “a protocol designed with multiple sub-studies which may have different objectives and involves coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure.”
Simply put, a master protocol acts like a map showing many routes to get to a destination where the sponsors don’t know in which direction their study will evolve, until the trial is under way.
There are two types of trial designs that fall under Master Protocols: Basket Trials and Umbrella Trials.
A basket trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics.
An umbrella trial is designed to evaluate multiple investigational drugs administered as single drugs or as combination drugs in a single disease population. Sub-studies can include dose-finding components to identify safe doses of an investigational drug combination before proceeding with an activity-estimating component.
Even if an RTSM is designed to handle multiple paths, there are almost always unforeseen changes to the protocol that require amendments. Traditional custom-coded systems treat these amendments as new study builds with all custom coding, and therefore the process to modify the system is incredibly lengthy, costly and challenging. Partially-configurable systems still require some level of custom coding, leaving sponsors to choose between working within the limitations of the preset system configurations, or introducing delays while custom code is developed.
Sponsors should not settle for the delays and limitations of a “multiple RTSM in one” approach, but rather seek an RTSM that was built to enable flexibility to follow the science (no matter how many amendments or supply changes are needed) with robust quality and audit trail reporting.
The solution? Modern RTSM systems. Modern, fully-configurable RTSMs offer robust configuration options that support the level of complexity a master protocol demands, and reduce the operational and administrative burden.
Per site, any new patient registered will fall under the new protocol version with whatever that entails
Lot management: The ability to sublot within the RTSM helps manage the re-label effort to specific regions.
Add countries: Sponsor can add them themselves.
Cohort-specific resupply: See which cohorts are open and project demand that is specific to the current status of the study.
Master protocols can become incredibly complex as sponsors follow the science of their study. Unlike traditional systems which can be rigid, Prancer RTSM™ enables the flexibility to increase overall study efficiency and expediting drug development.
See the benefits of a modern, 100% configurable solution today: