TL13: How to meet the needs for high quality health outcome (HO) or patient-reported outcome (PRO) data in oncology trials?
*Dachuang Cao, Eli Lilly and Company 


With FDA approvals being at record lows and increasing payer demands, we as statisticians need to understand the full impact of HO or PRO and comparative effectiveness research, especially how to use this information to ensure the regulatory submission is appropriate to gain reimbursement. The purpose of the roundtable luncheon is to discuss the following aspects in oncology trials: 1) What do the following parties expect or need in terms of HO/PRO: a) regulatory or marketing, b) general scientific or medical audience (for manuscripts), and c) payer (for value decision-making) ? 2) What factors contribute to the gaps in the integration of HO/PRO in clinical development?  Some potential ones are listed below:  a) lacking of HO/PRO instruments that are acceptable for the regulatory agency; b) disconnection between clinical trial endpoints and what payers are prepared to pay for; c) lacking of incorporation of PRO in statistical designs. 3) How can statisticians contribute to fill the gaps?