Statistical Issues for the Companion in Drug-Diagnostic Combinations
View Presentation View Presentation
*Nusrat S Rabbee, Genentech, Inc. 


Statistical issues in drug-diagnostic co-development through clinical trials are numerous and critical for success. The issues range from exploratory analyses methods in the earlier phases of trials where the biomarker and its discriminative cutpoint or algorithm are established to novel designs of later phase trials where the biomarker is validated as a patient selection device for the drug. Drug companies should use appropriate statistical methods and strategy to guide them along the entire way of this co-development process