This document provides recommendations for sponsors on data collection for cancer clinical trials submitted to FDA to support marketing claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications for new indications. The data collected should be sufficient to evaluate the safety and effectiveness of the treatment but need not include other data. This guidance is also intended for private investigators, cooperative cancer groups, contract research organizations, and others designing and conducting studies that later can be used in a marketing application for an anticancer drug or biological product.