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The Ultimate Guide to Managing Complex Clinical Trial Protocols

How to operationalize master protocols, including basket and umbrella trials.

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What is a master protocol?

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.”

open-quoteThere is an understanding that master protocols will look dramatically different in a few years (i.e. 20+ cohorts). These trials need to be designed in a way that can support multiple protocols, amendments, patient populations and supply chains, all while maintaining quality and patient safety.close-quote

Kelly Koziol, Senior Director, Client Services, 4G Clinical

Master protocol study designs.

There are two types of trial designs that fall under Master Protocols: Basket Trials and Umbrella Trials.

  • Basket Trials

    Single drug or drug combination across multiple disease populations.

    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.

     

  • Umbrella Trials

    Multiple investigational drugs in a single disease population.

    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.

Single drug or drug combination across multiple disease populations.

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.

 

Multiple investigational drugs in a single disease population.

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.

Master Protocol Studies - A Map to an Unknown Destination

Explore all the possible paths your clinical trial can take.

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Managing different paths within RTSM for a single study.

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. Modern RTSM can enable creativity in study design.

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A solution that supports your evolving needs.

Sponsors should not settle for the delays and limitations of a “multiple RTSM in one” approach, but rather seek a modern 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.

Master Protocol Studies White Paper

Technology considerations for 'never-ending' trials.

Enable efficiency in oncology trials with a modern RTSM.

Modern, fully configurable RTSMs offer robust configuration options that support the level of complexity a master protocol demands, and reduces the operational and administrative burden.

  • Cohort Management

    Flexible cohort management

    • Self manage cohorts including opening/closing cohorts, grouping cohorts, cohort assignments, etc.
    • Increase enrollment caps as studies progress to control data collection, discover recommended dose levels or explore expanded targets.
    • Choose to reserve slots for specific patients or specific sites
    See how
  • Protocol Versioning

    Control protocol versions

    • Sponsors can assign the different protocol versions to different sites
    • Each version can be connected to a different visit schedule or specific cohort - whatever the protocol change requires
    • Per site, any new patient will fall under the new protocol version with whatever that entails
    Learn More about Prancer RTSM
  • Dynamic Supply Adjustments

    Adaptive supply management

    • 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.
    Need for Better Solution

Flexible cohort management

  • Self manage cohorts including opening/closing cohorts, grouping cohorts, cohort assignments, etc.
  • Increase enrollment caps as studies progress to control data collection, discover recommended dose levels or explore expanded targets.
  • Choose to reserve slots for specific patients or specific sites
See how

Control protocol versions

  • Sponsors can assign the different protocol versions to different sites
  • Each version can be connected to a different visit schedule or specific cohort - whatever the protocol change requires
  • Per site, any new patient will fall under the new protocol version with whatever that entails
Learn More about Prancer RTSM

Adaptive supply management

  • 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.
Need for Better Solution

Cohort Management for Complex Oncology Designs

If the success of your study depends on being able to follow the science, flexible cohort management should be a key factor in choosing your RTSM.