Adopting an alternative structure for clinical trials in immunotherapy.

Abstract:

: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 immuno-oncology.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 microenvironment characteristics be grouped to determine the clinical benefit of immunological combinations that enter clinical trials. In addition, mega data from larger trials in which patients are subcategorized as above can provide the necessary data as a substitute for current double blind placebo trials which do not take into account the immune status of the host and tumor.Conclusion: There needs to be evolution of the clinical trial landscape so that it matches the exponential growth of the field of immunotherapy.

authors

Roussos Torres ET,Epstein AL

doi

10.1080/14737140.2021.1875822

subject

Has Abstract

pub_date

2021-01-19 00:00:00

pages

1-3

eissn

1473-7140

issn

1744-8328

pub_type

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