Modern Clinical Trials: Seamless Designs and Master Protocols

Thu, 23 Apr 2026 22:29:16 -0700

ABSTRACT

Background

Drug development is often inefficient, costly and lengthy, yet it is essential for evaluating the safety and efficacy of new interventions. Compared with other disease areas, this is particularly true for Phase II/III cancer clinical trials where many drug candidates fail to advance and reduced regulatory approvals are being seen. In response to these challenges, seamless clinical trials and master protocols have emerged to streamline the drug development process.

Methods

Seamless clinical trials, characterised by their ability to transition seamlessly from one phase to another, can lead to accelerating the development of promising therapies while Master protocols provide a framework for investigating multiple treatment options and patient subgroups within a single trial.

Results

We discuss the advantages of these methods through real trial examples and the principles that lead to their success while also acknowledging the associated regulatory considerations and challenges.

Conclusion

Seamless designs and master protocols have the potential to improve confirmatory clinical trials. In the disease area of cancer, this ultimately means that patients can receive life-saving treatments sooner.

Issue Information

Thu, 23 Apr 2026 22:23:20 -0700

Cancer Medicine, Volume 15, Issue 5, May 2026.