Question ID: Feb 2-5
Submitted by: February 2, 2011 Clinical and Translational Sciences Provocative Questions Workshop - Submitted to the website
March 3, 2011
How do we modify our clinical trials system to determine the optimal criteria for rapidly evaluating new cancer therapies?
Background: There are many new agents in the development pipeline. However, the testing of agents is constrained by limited resources and patients for conducting clinical trials. Moreover, traditional clinical trial designs may not be useful for some targeted agents, and unsuccessful trials have rarely been studied further to gather the benefits of failure.
Feasibility: It may be useful to select for clinical development only those agents that demonstrate proof-of-mechanism and preclinical efficacy in cell culture or in animal models. Further, a method that could be used in a clinical trial to determine if the putative target or its pathway is being inhibited could help accelerate drug evaluation. Other biomarkers (when available), intermediate endpoints, and stopping rules could be incorporated in clinical trial design.
Implications of success: Focusing on drugs that have shown proof-of-mechanism and have clinical assays to monitor target or pathway inhibition may hasten the availability and development of agents with greater potential among those in the pipeline, result in better patient selection and fewer failures in late stage development, and provide insight into those tumors or trials in which the treatment is not successful.
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