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

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Number of seamless clinical trials in oncology has risen recently