Goal:
The patients’ perspective has never been more important in medical evaluations and interventions. Clinical researchers are routinely incorporating Patient Reported Outcomes (PRO) assessments in trial programs and health care providers are increasingly considering PRO information to make decisions on treatment and patient management. In addition, regulators are asking for more meaningful endpoints that accurately reflect patient needs and values.
Background/Overview:
The patients’ perspective has never been more important in evaluations of medical products and in treatment effectiveness research in general medical evaluations and interventions. Clinical researchers routinely incorporate patient reported outcomes (PRO) assessments in clinical trials and observational studies while health care providers are increasingly using PRO information in shared decision-making with patients. In addition, regulators and health technology assessors at different levels of the health system consider PRO studies of efficacy and effectiveness of medical products for labeling and reimbursement. They are asking for meaningful patient-based endpoints that accurately reflect patient needs and values.
Working Groups:
Accomplishments
Current Activities
2010
ISPOR 15th Annual International Meeting in Atlanta, Georgia
ISPOR RECOMMENDATIONS ON THE FDA’S GUIDANCE FOR INDUSTRY PATIENT REPORTED OUTCOME MEASURES: USE IN MEDICAL PRODUCT DEVELOPMENT TO SUPPORT LABELING CLAIMS
Forum Description
Past Activities |
