Designing Patient‑Centric Master Protocols: The Role of Randomisation and System Implementation

Master Protocols are innovative, highly complex trial designs that can deliver significant efficiencies for sponsors while improving the patient experience. Central to this is randomisation, particularly when adaptive design features are applied to support flexibility as trials evolve.

However, realising the full patient‑centric potential of a Master Protocol depends not only on statistical design, but also on how effectively the randomisation system is implemented.

In this article, Jennifer Ross, Kevin Venner and Noelle Sassany explore how thoughtful randomisation design and flexible system implementation can work together to enable truly patient‑centric Master Protocols.