This workshop has four primary goals, which are to: 1. Discuss the development and utility of Patient Reported Outcomes (PRO) methods systems, the PRO- Common Terminology Criteria for Adverse Events (CTCAE) and contrast to the commonly used National Cancer Institute-CTCAE system of adverse event report in oncology clinical trials. 2. Provide an overview of electronic Patient-Report Outcomes (PRO) systems. 3. Review the use of Patient Reported Outcomes (PRO) data in oncology drug approvals and labeling. 4. Review modeling and simulation approaches to assess pharmacokinetic- Patient Reported Outcomes (PRO) relationships to optimize dosing. At the conclusion of the workshop the participant have an understanding of (i) the importance of PRO data in defining the optimal dose, (ii) how PRO data may be integrated into the study protocol and data collected, and (iii) how PRO data may be incorporated into labeling language.