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The Rapidly Evolving Need for Master Protocols

Master Protocols are advanced and innovative clinical trial designs that can evaluate multiple therapies and disease populations within a single overarching protocol. The general goals are improving efficiency and establishing uniformity through standardization of procedures in the development and evaluation of different interventions. Master Protocols are often classified as basket trials, umbrella trials and adaptive platform trials, and they can also include several complex studies. Their growing use creates new opportunities for clinical benefit and financially sound decision-making.

The coronavirus pandemic has also showcased the benefits of such master protocols in quickly deploying vaccines trials during complex emergencies. Adaptive platform trials are ideally suited to the COVID-19 challenge, as multiple treatments can be simultaneously tested, arms can be added as new candidate treatments emerge, and arms can be dropped as candidate treatments are found to be ineffective or harmful. The master protocol design allows for data-pooling and rapid discovery across therapies under study. The recently announced benefits of fluvoxamine, an inexpensive drug currently approved as an antidepressant, for treating COVID-19, were confirmed thanks to a platform research study, the TOGETHER Trial, which included key design and implementation contributions from Cytel researchers.

There is high interest in master protocols and its growth potential is also immense. However, employing Master Protocols requires a broader understanding of both Bayesian and Frequentist methods, as well as keen awareness of therapeutic area. Bayesian methods are particularly useful for complex trial designs, as they enable greater flexibility and better ability to respond to the needs of the master protocol designs.

Cytel is hosting a complimentary three-part webinar series that focuses on Expanding Applications of Master Protocols. During the webinars, Cytel experts - Dr. Kyle Wathen, Ed Mills, Ph.D., and James Matcham - will present Master Protocols in a global health context, share the trends in Bayesian Basket Studies and discuss the findings that can be applied to new trial designs. Click below to register.

Register


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About the Author of Blog:

Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.