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.
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.)
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.
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.
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.