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Lung Cancer “Master Protocol” Eyed As Paradigm-Changing Approach To Drug Development

Executive Summary

The biomarker-driven, multi-arm, multi-drug registration trial is expected to get under way in March 2014 with five drugs from different sponsors. With the promise of greater speed and efficiency in patient enrollment and late-stage development, it is being viewed as a potential model for other cancer settings.

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Master Protocols In Practice

Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer.

Rethinking Oncology Development: Master Protocols May Shorten Time To Approval

Master protocols that allow for the simultaneous study of multiple agents will shave more time off in the clinic than one-off studies in small groups of patients, FDA’s Janet Woodcock predicted. The current timeframes in oncology development are “unacceptable,” and can be shortened, she said, by “doing things differently.”

Lung-MAP Patient Screening Should Translate To Cost-Savings

Sponsors say the large number of biomarkers that will be searched for in candidates for the lung cancer trial should allow researchers to find patients much faster, and will offer cost-savings over traditional drug development.

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