Toolbox for conducting Master Protocol Trials - Basket, Umbrella, Platform Trials etc.

The Master Protocol Toolbox, MaP is a free open access collection of resources for planning and conduct of Master Protocol Clinical Trials.  

A master protocol is a study protocol design that includes multiple sub-studies, which allows for the investigation of multiple drugs or multiple conditions under a shared framework across all its sub-protocols. These include innovative types of clinical trial designs also known as complex clinical trials—such as platform1, umbrella2, and basket3 trials which are designed to be faster, more flexible, and are often used in areas such as cancer research. 

Search the toolbox

Planning & Design

  • Patient Engagement

    Find resources to help integrate patient perspectives throughout the trial lifecycle, from shaping the research question to reporting and evaluation, including informed consent guidance and best practices for stakeholder collaboration.

  • Complex Innovative Design

    Find resources on master protocol designs to help you plan flexible, efficient, and patient-centric trials that assess multiple Investigative Medicinal Products (IMPs) or diseases, within a shared framework across sub-protocols.

Trial Conduct

  • Trial Management

    Access practical resources on implementing and managing master protocol trials, including lessons learned, templates, and strategies for real-world challenges from trial conduct through close-out.

  • Safety/Pharmacovigilance

    Find guidance on patient safety, monitoring, and pharmacovigilance. Safety considerations in complex and master protocol trials follow the same principles as any other type of clinical trial.

  • Reporting

    Discover guidance to improve transparency and consistency when reporting master protocol trials — including best practices for registering, structuring, and disclosing results for individual substudies.

Regulatory

  • European Regulations

    Access key guidelines and official documents on master protocols (EMA). 

  • Regulatory Challenges

    Discover regulatory challenges encountered  in real world master protocol trials, with insights to help you navigate them.

Statistics & Data Management

  • Data Management

    Get practical guidance for managing and monitoring data in flexible master protocol trials, from maintaining data quality across changing treatment arms to establishing oversight structures like data monitoring or steering committees.

  • Statistical Ressources

    Access resources to plan, design, and analyse complex master protocol trials using appropriate statistical approaches.

How to use this toolbox? 

The MaP toolbox contains tools and resources, that include Regulatory guidelines (EMA), checklists, templates, meta-analyses, and expert recommendations from researchers experienced in complex clinical trials (platform, umbrella or basket trial) in cancer or other diseases. While many resources focus on trial design, others address key areas such as statistics and data management, and other specificities unique to these trial types.  

You can search by:

  • Category (Planning and Design, Trial Conduct, Regulatory, Statistics and Data Management)
  • Subcategories (Complex Innovative Design, Reporting, European Regulations, Data Management, etc.)
  • Trial design type (adaptive platform, umbrella, basket)
  • Keywords
  • Disease area (Cancer, etc.)

MaP offers a mix of tools and resources:

  • Tools: specific software, instruments, or templates that are ready to use.  
  • Resources: documentation, guidelines, recommendations or journal articles that can provide information for planning, design or implementation of a clinical trial with a master protocol.