  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 high attrition rates 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, characterized 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 principals 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.
