The task force’s goal is to develop emerging good practice recommendations for designing prospective real-world studies that collect patient reported outcome (PRO) data.
Global regulators, payers, and policy makers have indicated that PRO data can provide valuable information on the effectiveness, safety and tolerability from the patient perspective. Currently, there are no regulatory, health technology appraisal guidance nor publications pertaining to the standardization of patient reported outcome (PRO) data usage in RW studies.
While several guidelines on the implementation of PROs exist, they mainly focus on randomized control trials (RCTs) or clinical practice. They provide little or no recommendations for the use of PROs in the context of RWE generation, which would address the needs of regulators and policy makers. Practicalities of PRO data collection in routine care and methods of its analysis often pose a challenge for RWE researchers.