Patient centricity beyond buzzwords: What works

Most people talk about patient centricity like an elite membership, something fancy to check off a list. We like the sound of it, so we focus on that instead of how to make it work.

Patient centricity is one of the most widely used terms in clinical trial design, medical affairs, drug development, and healthcare delivery. It is positioned as the foundation of innovation and care in theory. You see it in strategy decks, clinical trial protocols, annual reports, and corporate mission statements. 92% of clinical trial executives believe trials are now more patient-centric than ever.

And yet, despite the attention, the reality for patients in drug development and healthcare delivery has not changed significantly.

In fact, the evidence tells a complicated story. There is a strong emphasis on patient centricity, but, in many cases, patient engagement is used to validate pre-existing assumptions, rather than inform initial decisions. This distinction is where the real work lies.

How patient centricity became a buzzword

Patient centricity became a buzzword around the mid-2010s, following recognition by the FDA and EMA of the importance of patient engagement across all stages of drug development, not just during clinical trials.

Since then, many theoretical advances have been made. Different frameworks were developed to support the cause, but many did not advance it. One landmark collaboration between the Drug Information Association, the Tufts Center for the Study of Drug Development, and 17 stakeholder organisations identified and defined 30 distinct patient-centric initiatives (PCIs) in active use across clinical research.

Patient centricity is the approach where the needs, values, and preferences of patients guide the planning and delivery of care. It centres on open communication, shared decision-making, respectful interactions, and the active involvement of patients and their families throughout the care journey. When executed well, it strengthens the clinician–patient relationship, improves adherence, reduces preventable hospital admissions, enhances the quality of medical research, and reduces unnecessary costs.

Tools such as Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) provide structured ways to obtain real-time patient feedback. This feedback informs service improvement, policy development, and accountability, which in turn advances patient care, solidifying patient centricity.

But definitions and frameworks can only take us so far, since the challenge is operational.

A recent analysis of Medical Affairs frameworks found that even well-designed approaches to patient centricity were developed without direct patient input. When guidance is built from an industry perspective, rather than a patient perspective, it favours organisational priorities over patient realities. Senior pharmaceutical industry panels agree that true patient centricity requires a change in cultural mindset, clearer internal roles, and active frameworks to measure success, not just language alone.

The reality patients actually experience

What patients experience in clinical research does not match the rhetoric. Decentralised clinical trial (DCT) research shows that requiring patients to travel repeatedly to trial sites increases dropout rates and reduces study effectiveness. For patients managing chronic illness or limited access to transport, the cost of participation is high.

Beyond logistics, patients often enter systems with inadequate information and preparation. Research using the Patient Experience Mapping Toolbox (PEMT) shows that patient experience extends far beyond treatment response. It includes misdiagnoses, healthcare system interactions, information-seeking behaviour, side effects, and comorbidities. When what is measured does not reflect patients' reality, the data generated is ineffective.

Knowledge gaps also exist among those responsible for protecting patients. A training programme under the Patient Advocates for Clinical Research (PACER) initiative found that only 16.5% of ethics committee members were familiar with the primary ethical considerations for vulnerable populations. These are the same individuals reviewing the trials patients are asked to trust.

Where the disconnect happens

The gap between intent and execution appears in several ways across the pharmaceutical industry. First, protocol design continues to prioritise operational convenience over patient experience. Second, technology is introduced as a guaranteed solution. Finally, patient engagement remains largely symbolic.

In Medical Affairs, a proposed framework covering five focus areas – medical strategy, communication, evidence generation, patient engagement, and care experience – was developed without patient engagement. When patients and patient organisations were later engaged through questionnaires, two focus areas were excluded: digital health and patient medical education.

There is also a gap between what digital health promises and what works in practice. Digital tools such as apps and wearables can collect continuous, real-world patient data. However, only a small number of these measures are accepted by regulators or used as evidence of treatment effectiveness.

A major reason is that developers often cannot demonstrate that the data collected is meaningful to patients – something regulators increasingly require. Recent FDA decisions have shown rejections in many cases where digital measures fail to meet this standard.

What patient centricity actually looks like

For patient centricity to work, it has to be built into processes, not added on as an afterthought. One example is the Patient Motivation Pyramid, a framework used to map patient needs. When applied effectively, it improves clinical trial design, making studies more feasible, easier to run, and more engaging for patients. Research also shows that patient input must occur early before protocol decisions are made.

DCTs demonstrate what this redesign looks like in practice. By reducing the need for travel, involving patients in consent design, and incorporating their perspectives into outcome assessment, DCTs have reduced dropout rates, improved study effectiveness, and shortened time to market. Both the FDA and EMA have updated regulatory guidance to reflect this shift.

Companies such as Alexion and AstraZeneca Rare Disease use programmes such as STAR and LEAP to involve patients directly in shaping drug development and launch strategies. This approach is also relevant in formulation science, where changes in administration routes, dosing frequency, and drug delivery often originate from patient feedback. When patients influence these decisions early, outcomes improve.

The role of AI: Opportunity or amplifier?

Artificial intelligence, machine learning, and deep learning are increasingly influencing diagnosis, disease management, patient journey mapping, and outcome prediction. Virtual randomised controlled trials (vRCTs) extend this further by enabling continuous, real-time data collection outside the traditional site settings while improving patient centricity, compliance, and recruitment.

However, the risks associated with AI are proportionate to its promise. Biopharma operates in complex environments characterised by fragmented data systems, limited interoperability, complex data governance, and strict patient privacy requirements. At the same time, regulatory expectations for AI in clinical research are still evolving.

The issue is clear: if these tools are applied to processes that are not patient-centred, they will not solve existing problems. Instead, they will reinforce them.

Technology alone cannot fix systemic issues; it only scales them.

From language to action

The path forwards is not the development of more frameworks, but the application of what evidence already supports.

The evidence is clear: advocacy groups, patient advisory panels, and focus groups consistently deliver the highest impact at the lowest cost. When applied early, these approaches can shape trial design and improve outcomes.

Patient centricity beyond buzzwords cannot be delivered in isolation. It requires coordinated action and shared accountability across stakeholders. No single team or organisation can achieve it alone.

At its core, it demands a simple but difficult shift: measuring what matters to patients, not just what is easiest to measure, and not just what matters to organisations.

About the author

Deborah Sabinus-Chinonso, MPH, is a medical writer with a background in human physiology, public health, and clinical research, specialising in digital health, public health strategy, and evidence-based healthcare communication. She translates complex clinical research and health innovation into clear, evidence-based content for healthcare and healthtech audiences.