In our work, we've encountered a wide gamut of attitudes toward the Patient Voice, from genuine dedication to mere tokenism. It’s like they can be measured along a 10-point “Patient Voice Scale of Sincerity”, ranging from phoney to committed. The true nature of their commitment often reveals itself in subtle and simple ways.

By involving patients early and throughout the research and development process, patient input - or engagement - helps reduce late-stage failures, enhance recruitment and retention, and improve overall pharmaceutical productivity and drug quality.

The notion of the Patient Voice is anchored on philosophies around patient-centred care. This assumes that there has been a shift from a passive patient role within the doctor-centred biomedical model. This focused solely on physical disease aspects and overlooked patients' social and psychological experiences. Consequently, this has moved to a patient-centred approach. This modern approach redefines patients as active partners, emphasizing three core values: addressing individual needs and experiences, encouraging patient participation in care, and fostering strong patient-doctor partnerships through empathy, effective communication and emotional intelligence.

Patient-centred care seeks to understand each patient's unique perspective and context, ensuring that treatment decisions align with their values through shared decision-making. This means that doctors need to treat patients holistically, considering factors like illness history, emotional distress, culture, and socioeconomic status. Cutting-edge drug development is wedded to the assumption that patient-centred care is a widespread reality: you can’t have personalised medicine without it.

Author: Mark Gibson (mgibson@grc-health.com)

Gibson Research Consultancy (grc-health.com)

References:

[1] Chalasani M, Vaidya P, Mullin T, Enhancing the incorporation of the patient’s voice in drug development and evaluation, Research Involvement and Engagement, 2018 Apr 2; 4:10

[2] FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making, US Food and Drug Administration, published April 2023

[3] Foster A, Cervical screening knowledge gap 'costing lives', BBC News, 20 January 2025

[4] Montalt-Resurrecció V, García-Izquierdo I, Muñoz-Miquel A, Patient-Centred Translation and Communication, Routledge, London, 2025

[5] Newton S, Clinicians have been urged to move away from the “doctor knows best” view, Independent, 18 December 2023

[6] Patel A, Fiebling D, Muszka J, The utility of Patient Experience in drug research and development, Pharmaceutical Medicine, Volume 35, p. 157-162, 2021.

[7] Pitts PJ, Towards meaningful engagement for the patient voice, Patient-Centred Outcomes Research, Volume 12, p 361-363, 2019

[8] Zvonareva O, Gravet C, Richards DP, Practices of patient engagement in drug development: a systematic scoping review, Research Involvement and Engagement, 2022 Jun 29; 8:29

About the author:

Mark Gibson, MA, BA (CEO, Gibson Research Consultancy)

Mark Gibson is the owner and (reluctant) CEO of Gibson Research Consultancy (GRC) Ltd. Based in Leeds, United Kingdom. GRC is a small company with a broad reach: it has staff across four continents, conducts Patient Voice-related projects in over 190 countries and partners with over 22000 professional research and health professionals around the world. Its business model is typically to ‘white label’ for bigger partner companies, which means that they are possibly the most prolific purveyor of services like cognitive debriefing for COA or usability testing for eCOA that nobody has ever heard of.

Mark’s interest in the Patient Voice spans three decades and has seen a number of manifestations of this. He became immersed in Patient Voice research (it was simply called ‘research’ then) upon embarking on an academic career, and specialised early on in hard-to-reach and marginalised communities. The university career was unfortunately short-lived due to commercial activities, also in the area of the Patient Voice. Mark has never lost the passion and the commitment from those early days and hopes that this is reflected in the essay.