Patient Global Impression of Benefit-Risk (PGI-BR): Incorporating Patients' Views of Clinical Benefit-Risk into Assessment of New Medicines.

Introduction: There is a need to understand how patients assess perceived benefits and risks of treatments.

Objectives: The study aimed to (i) elucidate how patients evaluate treatment experiences and (ii) develop a brief patient-reported outcome (PRO) instrument for use across disease areas for perceived benefit-risk evaluation of a new medicine in a clinical trial setting.

Methods: Concepts relating to patient-perceived benefit-risk were identified from literature reviews and qualitative concept elicitation interviews with patients across a variety of primary medical conditions.

Development of a Conceptual Model of Chronic Lymphocytic Leukemia to Better Understand the Patient Experience.

Background And Objective: Understanding the patient experience is important for identifying the unmet need in chronic lymphocytic leukemia. The current study aimed to develop a comprehensive chronic lymphocytic leukemia conceptual model.

Methods: The conceptual model was based on literature searches, review of chronic lymphocytic leukemia patient blogs/forums, and interviews with five expert clinicians, with 20 patients who received at most one treatment (first line) for their chronic lymphocytic leukemia, and with 20 patients with relapsed or refractory chronic lymphocytic leukemia.