For me, the Patient Voice has its deficiencies as a term. It feels like one-way traffic: the patient lends their voice to the drug development process, at various points in the clinical phase and beyond. It is something that patients give and researchers take. Patient Voice research yields anonymised data of their insights, their perceptions, their beliefs. These are then mined, stripped, catalogued, distilled and analysed. Patients hardly ever see what happens beyond their involvement.

‘Patient Engagement’ is a much more favourable term. It implies two-way traffic. It feels like there is a commonality of purpose: the organisation and the patient come together. They engage with each other. There is a benefit to both. Modern health delivery in many countries is based on the concept of patient engagement.

It emphasises the active involvement of patients in their own care and has become an institution and a cornerstone of health policy in countries like the UK. According to this model (or belief?), patients that are engaged make better, informed decisions about their health, they act in league with their healthcare providers and take ownership of their own health outcomes. Through empowerment that comes through engagement, patients - people like us - hold their own health destinies in their own hands.  

This philosophy has found its way into policy in a plethora of organizations, such as WHO, FDA, the UK’s National Health Service, EMA, often supported by academic and professional bodies, like the BMJ and PCORI. In Big Pharma, patient engagement is taken very seriously and reinforced in clinical trials. Some of us are engaged in the development, validation and testing of Clinical Outcomes Assessments. This is because of the importance that bodies such as the FDA and EMA place on integrating Patient-Reported Outcomes (PROs) into drug approval and regulatory frameworks.

There are four pillars of patient engagement:

• access to information

• shared decision-making

• self-management

• transparency / accessibility.

Without these, patient engagement cannot happen. These have become the foundation of a patient-centred healthcare system.

Yet, many people are faced with systemic barriers, lack of resources and limited healthcare access. This has an impact on the extent to which they can use information adequately, they can make decisions about managing their own health and have difficulty accessing even basic health services. This means that patient engagement is only ever partial. It feels more like patient disengagement. There is a gap between the ideal – the engagement that exists in policy – and the reality.

If patient engagement is to be more than a lofty ideal, we must address the disconnect between policy and practice. The pillars of engagement cannot stand if they are only accessible to a privileged few. True engagement requires dismantling systemic barriers, ensuring equitable access to resources, and fostering a culture where patients are not just participants but partners in their own healthcare journeys. Until then, patient engagement remains an aspiration rather than a reality.

Thank you for reading.

Mark Gibson

Boston, USA, November 2024