Using Interactive Response Technology to Implement Bayesian Futility Analysis in Basket Trials

Traditional Phase 1, 2, and 3 oncology trials are becoming increasingly difficult and time-consuming due to the number of different genetic mutations and cancer types that continue to be discovered.

Basket trials have emerged as an innovative new trial design that can significantly speed the drug development process, but adoption of this new study design can be complicated. High startup costs, complex protocols, contract complications and regulatory approval are some of the biggest obstacles that can prevent trial completion and ultimately delay an effective medicine reaching a patient.

In this webinar, Incyte, a leading biopharmaceutical research company specializing in innovative oncology medicines, discusses the implementation of Bayesian Futility Analysis in basket trials and how they utilized Suvoda’s IRT system to decrease start-up time and mitigate risks while addressing specific business needs. This webinar will go through Incyte’s clinical protocol in case study format and how Suvoda’s IRT system helped simplify the complexities commonly facing oncology trials. The webinar will review the procedures and methods of validation involved in translating data into the IRT system, and how Suvoda helped Incyte successfully implement Bayesian Futility Analysis.

Register for this webinar to discover:

• The benefits of Bayesian Futility Analysis implementation for your study and study teams
• How to ensure accuracy between the results of Suvoda’s IRT system and your statistical program
• The importance of this study approach for future oncology studies

Speakers

Erica Jonas, Associate Director of Services Delivery, Suvoda

As Associate Director of Services Delivery, Erica has responsibility for project management, account management and IRT services delivery for Suvoda’s customers. Erica has successfully managed IRT system designs for a variety of global pharmaceutical and biotechnology sponsors on a range of indications including oncology, schizophrenia, major depressive disorder, and dermatology. She has an MS in Health and Biopharmaceutical Economics and a BS in Bioengineering from Lehigh University.

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Catalina Pagan, Services Design Consultant, Suvoda

As a Design Consultant at Suvoda, Catalina specializes in defining the behavior of Interactive Response Technology (IRT) systems customized to manage drug supply and treatment assignment at a study-specific level. While her focus has been on oncology studies, she has also collaborated with global pharmaceutical sponsors to design systems for a variety of indications. Catalina also has extensive experience in project management and a BS in Biological Engineering from Cornell University.

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Feng Zhou, Ph.D., Principal Biostatistician, Biostatistics, Incyte

Feng Zhou joined Incyte in April 2016 as a principal statistician and has been working on clinical trials in both solid tumors and hematologic malignancies. During her time with Incyte, she’s done extensive research in the comparison of dose finding approaches for Phase I oncology trials. Feng has also contributed to the implementation of Bayesian Futility Analysis in basket trials for several early phase oncology trials. She obtained a Ph.D. in Statistics from the University of Kentucky.

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