Abstract
The OPTIMAprelim pilot trial in early breast cancer aims to select multi-parameter tests for inclusion in a phase III trial evaluating their use for patient selection for chemotherapy. Patients are randomised between universal chemotherapy or test-directed chemotherapy. A key criterion for inclusion of a test as a comparator will be the expected value of further research into its clinical and cost-effectiveness.
Highlights
The OPTIMAprelim pilot trial in early breast cancer aims to select multi-parameter tests for inclusion in a phase III trial evaluating their use for patient selection for chemotherapy
Patients are randomised between universal chemotherapy or test-directed chemotherapy
Characterising the uncertainty and value of information associated with test performance parameters and the expected outcomes conditional upon test results is feasible on the basis of test concordance data, even with limited current long term outcomes data
Summary
Efficient design of a phase III trial of competing tests for personalised cancer treatment in the absence of gold standard outcome data: challenges and potential solutions. Peter Hall1*, Christopher McCabe, Claire Hulme, Richard Edlin, Janet Dunn, David Cameron, Rob Stein. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. 18-19 November 2013
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