MaP Toolbox: Your Hub for Master Protocol Clinical Trials

Oct 9, 2025

Clinical trials are evolving. Traditional study designs, testing one drug in one disease, can be slow and resource intensive. In fields like oncology or rare diseases, where efficiency and flexibility are critical, innovative trial designs are transforming the way research is done.

One such approach is the Master Protocol Clinical Trial.

 

🔎 What is a Master Protocol trial?

A master protocol is a study design built around an overarching framework that can include multiple sub-studies (or sub-protocols).

This design allows researchers to investigate:

  • Multiple drugs within a single disease area, or
  • One drug across multiple conditions or patient populations.

Instead of designing and launching new trials from scratch each time, a master protocol provides a common infrastructure that supports efficiency, adaptability, and faster progress.

Figure from: Park, J.J.H., Siden, E., Zoratti, M.J. et al. Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols. Trials 20, 572 (2019). https://doi.org/10.1186/s13063-019-3664-1

⚡ Types of Master Protocol designs

Master protocols are also called complex or innovative clinical trials and are typically grouped into three types:

🔀 Platform trials:  allow multiple treatments to enter or leave the trial over time, under an overarching protocol

☂️ Umbrella trials: test multiple targeted therapies in patients with the same disease, but with different genetic or molecular markers

🧺 Basket trials: test a single therapy in multiple diseases or disease subtypes that share a common characteristic

These trial designs are increasingly used in cancer research, but their usage is also expanding into other disease areas.

 

🌍 Why are Master Protocol trials important?

  • Faster → by testing several questions within one framework.
  • Flexible → treatments or arms can be added or removed as needed.
  • Efficient → shared infrastructure reduces duplication of effort.
  • Informative → enable exploration of targeted, precision medicine approaches.

 

📚 Learn more

Want to explore  how researchers can plan and conduct Master Protocol Clinical Trials?

Check out the Master Protocol Toolbox (MaP), a free, open-access collection of 100+ resources including guidelines, templates, checklists, and expert recommendations:

Access MaP Toolbox