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Background: This evaluation emphasizes the main points of the original article ‘Position paper: new insights into the immunobiology and dynamics of tumor–host interactions require adaptations of clinical studies’ by Sprenger et al. and provides further justification for the use of an alternative approach in the design of human clinical trials for new investigational drugs in the field of immunooncology.
Objective: Standard trial design utilizing the double blind placebo trial approach, while effective for drugs that directly treat tumors, is too costly, slow, and not effective for drugs and protocols that depend on activation of the immune system for killing of tumors.
Methods/results: This paper has proposed through the use of detailed diagnostic profiling, small groups of patients with similar tumor micro…