title: Patient registries as a new quality measurement and method the assessment of the treatment effectiveness
abstract: Randomized controlled trials (RCTs) are still regarded as golden standard for the assessment of efficacy and safety of pharmaceutical products. Nevertheless, there is a growing interest into the real world data (RWD) as decision makers more and more often require data on the effectiveness of new treatment and other real life consequences of its implementation into the clinical pathways. In Poland, a number of challenges hinder the full utilization of RWD in the pricing & reimbursement (P&R) processes. Among them, there are legal rules regarding data privacy and undeveloped system of electronic medical records. It is therefore encouraging to investigate the examples of jurisdictions that have already started the utilization of RWD in their decision making processes. In this article the examples of Sweden, Great Britain and Holland are studied. The learnings can hopefully provide some valuable insights that will help the Polish decision makers to meet their challenges on the way to the successful RWD’s implementation in P&R processes.
authors.affiliation: Collegium Medicum Bydgoszcz, Fundacja MY Pacjenci
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Kolasa
authors.affiliation: Collegium Medicum Bydgoszcz, Fundacja MY Pacjenci
authors.forename: Ewa
authors.initials: E
authors.lastname: Borek
mesh_terms: D022126:Access to Information; D057186:Comparative Effectiveness Research; D005260:Female; D006801:Humans; D033181:Information Dissemination; D008297:Male; D011044:Poland; D011634:Public Health / Q000706:statistics & numerical data; D011786:Quality Control; D058996:Quality Improvement; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012042:Registries / Q000592:standards*