tailieunhanh - báo cáo khoa học:" Patient reported outcomes: looking beyond the label claim"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Patient reported outcomes: looking beyond the label claim | Doward et al. Health and Quality of Life Outcomes 2010 8 89 http content 8 1 89 HEALTH AND QUALITY of life outcomes COMMENTARY Open Access Patient reported outcomes looking beyond the label claim Lynda C Doward1 Ari Gnanasakthy2 Mary G Baker3 4 Abstract The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic disabling conditions where the intention is not to cure but to ameliorate symptoms facilitate functioning or ultimately to improve quality of life. In such cases patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product s competitive advantage in the marketplace. In a commercial setting the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities payers both in the US and Europe clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups. Introduction In recent years the pharmaceutical market has become characterized by more knowledgeable customers growing cost pressure from private and public third party payers and increasing need for product differentiation in a highly competitive .