A guidance document issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and its Oncology Working Party (ONCWP) describes the use of Patient Reported Outcomes (PROs) and health related quality of life (HRQL) measures in clinical studies. This is especially important to obtain the perspective of patients as the treatment significantly impacts their well-being.
The new guidance provides:
• “Recommendations for the incorporation of PROs and HRQL in the clinical development of anticancer medicines;
• Advice on appropriate design, conduct and analysis of PRO studies.” •