This short collection of articles has taken a little glance behind the curtain of the Patient Voice, a small insight beyond the slogans. Nothing that I said or included is the stuff of advanced learning. What I have written here about the assumptions around patient-centred care and empowerment is sophomore bachelor’s reading at most. Any 101-level textbook would tell you this. It is interesting to note how circular the conversation is. What I have written here about patient empowerment is only regurgitated from books and papers I read decades ago, some of which were published as long ago as the 1950s.

Why is it so circular? Why am I reading articles in 2024 such as ‘Cervical screening knowledge gap ‘costing lives’, ‘Clinicians have been urged to move away from the “doctor knows best” view’. In the latter article, it quotes the report, jointly written by the Universities of Cambridge and King’s College London, that doctors are “paternalistic” to patients and should change “to a more equal relationship where patients’ lived experiences are taken on board.” This is the kind of recommendation found in reports published three decades ago. Even then, it felt tired. This is as tired as the well-worn cliché of ‘the more things change, the more they remain the same’.

There is a difference amongst companies in how seriously they take the Patient Voice agenda. But I wonder what commitment there would be if there were no longer any regulatory pressures in place. Here is a thought experiment: let’s suppose that Trump 2.0 makes cuts to FDA that indirectly causes an unravelling of a raft of regulations and best practice guidance in relation to the Patient Voice, particularly in the area of diversity. Let’s suppose this undoing has an impact on the ability of FDA to assess submissions, where capacity may disappear altogether. The result is that Patient Voice initiatives are no longer expected or properly regulated. No more real-world evidence (RWE) research required, no more cognitive debriefing, or comprehension testing, or risk evaluation and mitigation strategies (REMS) or anything to do with patient safety or health literacy. In this new reality, how many clinical research organizations (CROs) and Pharma companies do you think would still insist on Patient Voice research in drug development? How many sponsors would do it voluntarily? How many Patient Voice slogans decorating their conference booths? You would count them on one hand.

Written by Mark Gibson

Leeds, United Kingdom, December 2024

References used in this collection of Patient Voice articles:

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

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

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

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

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

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

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

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