The Sliding Scale of Sincerity towards the Patient Voice Agenda

Defining our company with one phrase has always been a challenge. We work across the entire lifecycle of drug and device development, in areas as diverse as Real-World Evidence, submissions, and pharmacovigilance, fields that have little to do with each other. So, what ties all these threads together? What is the ‘dark matter’, the invisible glue that binds these different sectors? The answer is simple: these all include engagement points with patients.

That’s the phrase that defines us: the Patient Voice. Most of our work involves testing documentation and technologies designed for patients. Whether this is qualitative interviews, cognitive debriefing, human-factor analysis, testing for comprehension, or health literacy levels, these are simply different methods that capture the Patient Voice.

My dedication to elevating the Patient Voice predates my entry into the commercial sector. It goes back to my first qualitative interview with a patient in the mid-1990s. This commitment is deeply personal. Those who have worked with me know that I am ‘all in’.

Since then, I have witnessed various cycles of the 'Patient Voice' agenda come and go: patient empowerment, engagement, perspectives, centricity, insights, and more. Turn the noun ‘patient’ into an adjective or a prefix and add another noun that sounds ‘enabling’ and there you have the next buzzword. Each time the concept resurfaces, it feels like another turn of the wheel, with few truly new ideas. Recommendations to do with the Patient Voice that are being published in journals today have already appeared in articles and conferences decades ago, only under other names, in other contexts, in other disciplines. It’s all been done before: popular for a while, quietly dies away and then comes back into vogue again – only in a different silo, at a different time.

Just over a decade ago, advocating for qualitative research that focused on the Patient Voice was a tough sell. Such research was often undervalued and dismissed by sponsors. Fast forward to today and we see that the Patient Voice agenda has gained widespread credibility because, crucially, it is enforced. In recent conferences, nearly every company with a booth proudly proclaims two things: “We use AI” or some slogan or other about the “Patient Voice”. These have become the latest mantras, the new bandwagons, the new sound. Except that they are not.

The first claim about AI, while it still feels novel, is also tired as a marketing position. These companies might as well declare “All our employees use laptops!” or “An internet connection gives us a competitive edge!” AI has become so integrated into our work that mentioning it will – very soon – be redundant. The second claim about the Patient Voice often rings hollow. I frequently question the sincerity behind these slogans and the true commitment of many of these companies.

Over the years, we have encountered a wide range of attitudes toward the Patient Voice amongst our clients, 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. One of these ways can be manifested in how the pharmaceutical industry chooses to communicate with their patients – because it is a choice – and I will focus more about this in forthcoming articles.

Crucially, this attraction to Patient Voice research is driven by regulations and guidance, such as FDA’s Patient Focused Drug Development (PFDD), which compel companies to adopt these practices. Without such external pressures, many would not bother. In fact, almost all of the projects I’ve been involved with in the pharmaceutical and device sectors were initiated precisely because a Competent Authority told them to do it.

At our core, we believe in the power of the Patient Voice not because it’s a trend or a regulatory checkbox, but because it genuinely transforms how we understand patients. The patient’s voice should be heard, valued, and integrated into all aspects of therapeutic development.

The next articles will focus on the theme of tokenism that, sadly, pervades the Patient Voice agenda.