Immunological monitoring of clinical trials using biological response modifiers

Phase I clinical trials of Biological Response Modifiers must be designed to provide information not only regarding toxicities, pharmacokinetics and anti-tumor response, but also on their many immunomodulatory properties. If BRMs are to be used rationally, then detailed standardized data must be obtained in such a way as to enable meaningful conclusions to be drawn from the monitoring assays. Assay selection, timing for monitoring and methods for data interpretation are important considerations in the design of such trials.