IOM to Develop Criteria to Help Sponsors Select Predictive Tests

To help sponsors design better clinical trials, an Institute of Medicine (IOM) committee is developing an evaluation tool to determine when predictive tests based on technologies such as genomics are an appropriate basis for a trial design. Harold Varmus, director of the National Cancer Institute, asked IOM to address the tests after he received a letter from 31 biostatisticians questioning predictive models developed at Duke University, IOM spokesman Michael Park said.
Clinical Trials Advisor