Seamless Trial Designs
Seamless Trial Designs
Challenging the Traditional Drug Development Paradigm
Seamless clinical trials combine two or more phases into one adaptive design study.
ARTICLES
Hobbs BP, et. al. Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology. Journal of the National Cancer Institute 111.2 (2019): 118-128.
Teng Z, et. al. Optimal seamless phase 2/3 oncology trial designs based on Probability of Success (PoS). Statistics in Medicine 37.28 (2018): 4097-4113.
GUIDANCE
Number of seamless clinical trials in oncology has risen recently
Biomarker Driven Studies
Statistical methods for establishing optimal treatment rules for matching patients to therapy.
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Master Protocols
Designs to simultaneously evaluating multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development.
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Short Course: Drug development of non-cytotoxics
Half-day Shortcourse: Subtype Identification and Strategies for Trial Design.
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