We present an initial exploration of a fully cost-driven design. A design criterion was proposed that represented the minimum expected cost of an early phase clinical study, where costs include resource use as well as study failure. The design was based on attainment of a target concentration in a cohort of study participants. The model and parameter values arose from a previous population pharmacokinetic analysis of a phase I study. The resulting design naturally balanced the cost and the success rate of an early phase clinical study, without the need to define arbitrary constraints on the design space.
Matched MeSH terms: Clinical Trials, Phase I as Topic/economics*
Immunization with anti-idiotype (Id) antibodies represents a novel new approach to active immunotherapy. Extensive studies in animal tumor models have demonstrated the efficacy of anti-Id vaccines in preventing tumor growth and curing mice with established tumor. We have developed and characterized several murine monoclonal anti-Id antibodies (Ab2) which mimic distinct human tumor-associated antigens (TAA) and can be used as surrogate antigens for triggering active anti-tumor immunity in cancer patients. Encouraging results have been obtained in recent clinical trials. In this article, we will review the existing literature and summarize our own findings showing the potential of this approach for various human cancers. We will also discuss where anti-Id vaccines may perform better than traditional antigen vaccines.
Matched MeSH terms: Clinical Trials, Phase I as Topic