OBJECTIVES: The FDA and EMA have published guidance documents to direct the development and inclusion of patient-reported outcomes (PROs) for drug approval and labeling.  The Center for Medical Technology Policy’s (CMTP) objective is to develop parallel guidance for post-regulatory decision makers for the appropriate inclusion of patient-reported outcome measures in the design and implementation of CER clinical trials. METHODS: A semi-structured questionnaire pertaining to the use of PROs in CER was developed based on a review of scientific literature and consultation with PRO study methodologists. In-depth interviews were conducted with 15 individuals from the clinical research, clinical practice, regulatory, payer, and patient communities. From these findings, an initial list of recommendations were developed, and the Center for Medical Technology Policy (CMTP) worked with a multidisciplinary technical working group of leading medical researchers, ePRO consultants, and patient advocates to establish a concrete set of recommendations.  Fifteen recommendations were incorporated in the guidance document and posted on CMTP’s website for a 2-month public comment period. Organizations were contacted to provide feedback through an online survey that elicited both Likert-scale questions and open comments. The guidance was then revised.  RESULTS: A list of 12 “core” symptoms was identified as key items to measure in all late-phase studies for cancer trials: anorexia, anxiety, constipation, depression, diarrhea, dyspnea, fatigue, insomnia, nausea, neuropathy, pain, and vomiting. The final recommendations provide guidance on selection of PRO measures, implementation methods and data analysis/reporting considerations. CONCLUSIONS: The patient perspective is an essential component of CER.  Standardizing PRO data collection in oncology trials will lead to greater comparability and improved patient-centered decision-making.