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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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.
Master protocol for Phase I/II screening trial could make development more efficient, but concerns about regulatory obligations, lack of registrational intent and infrastructure complexity – as well as firms' willingness to share – may be hurdles to participation.
Pioneering next-generation sequencing enrollment strategies are coupled with adaptive statistical designs in the next wave of drug "basket" trials from NCI, ASCO and Novartis.