Evidence Library

Title: Enhancing the incorporation of the patient’s voice in drug development and evaluation.
Author: Chalasani M, Vaidya P and Mullin T.
Date Published: 2018
Reference: Research Involvement and Engagement 4:10
Are service users or carers authors: No/Not Known

Abstract: People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focused Drug Development (PFDD) initiative to more systematically obtain the patient perspective on specific diseases and their currently available treatments. PFDD meetings are unique among FDA public meetings, with a format designed to engage patients and elicit their perspectives on two topic areas: (1) the most significant symptoms of their condition and the impact of the condition on daily life; and, (2) their current approaches to treatment. FDA has conducted 24 disease-specific PFDD meetings to date. The lessons learned from PFDD meetings range from experiences common across rare diseases to more disease specific experiences that matter most to patients. FDA recognizes that FDA-led PFDD meetings alone cannot address the gaps in information on the patient perspective. Patient-focused drug development is an ongoing effort and FDA looks forward to the next steps in advancing the science and the utilization of patient input throughout drug development and evaluation.

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Categories: health
Identifying topics, prioritising and commissioning
Designing research
impact on research
impact of public involvement
journal article

Date Entered: 2018/11/30

Date Edited: 2018/11/30

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