Patient-centric research: lessons learned from 25 years in Health Psychology

My journey into patient centricity

Nearly a quarter of a century ago I qualified as a Practitioner Health Psychologist. At first, I was not quite sure what direction that would take me in, but then I found something I was passionate about – “patient centricity”. Although inconsistently defined and operationalised, patient centricity provided me with a clear direction: listen, understand and use the patient perspective to guide the provision of care and treatment.

I was fortunate to qualify at a time when the UK healthcare system and pharma companies were starting to ask questions like “How can we maximise people’s health and well-being?” and “How can we balance clinical outcomes with quality of life?” These are important questions which can only be answered by working directly with patients and their caregivers, healthcare systems and medicines developers.

Six lessons from 25 years of patient-centred research

My career has offered me an opportunity to do exactly that. I have applied the principles of patient centricity to teaching, researching and providing care in academic institutions, at healthcare providers, pharmaceutical companies, and healthcare research and management consultancy firms.

Through this I have learnt some important lessons:

1. Science and empathy must go hand in hand Patient-centric research, medicines development and care delivery must be both scientifically robust and empathetic. Poor quality research should NOT be the basis of decision-making, patients should NOT be asked to do things which are not aligned with their priorities and preferences, outcomes MUST be measured in a reliable and valid manner, and information MUST be shared in a way that ensures patients understand it.
2. Understanding behaviour is essential to improving outcomes The principles of Health Psychology offer a solid basis from which to understand how and why people engage with care and treatment, what their priorities, preference and needs are, and how to measure outcomes that matter to patients at an individual and a population level. However, partnering with other social scientists – epidemiologists, sociologists, medical anthropologists – is important to provide a holistic understanding.
3. Patients want to contribute but they need to feel valued Patients want to share their stories and support developments in treatment and care even if it will not benefit them directly. However, they must feel engaged and valued and understand how their stories and experiences will be used.
4. True patient centricity starts with partnership True patient centricity requires partnership from the outset – with patient advocacy groups, healthcare professionals, caregivers and communities helping to shape what questions are asked.
5. Industry passion isn’t always matched by patient insight Medicines development is a lengthy, complex and heavily regulated process. Most people I know in the industry are passionate about getting life-changing medicines to patients quickly. However, they do not always invest in understanding or measuring the patient perspective in a reliable and interpretable manner.
6. Integrated evidence is the future Research to inform medicines development and clinical care decisions must be robustly designed and integrate data derived from clinical tests, from clinicians and directly from patients. Unfortunately, little research fully integrates these perspectives, but without them it is hard to draw conclusions that are clinically informative, patient-relevant, and practical. Regulators and HTA bodies are increasingly asking for this integration, with an expectation for medicines developers to build a coherent and holistic evidence story that connects clinical outcomes, patient experience, healthcare utilisation and long-term real-world impact.

Applying patient centricity in the real world

It was this last lesson that drove my recent move from IQVIA to Vitaccess.

At IQVIA I was part of a large multinational team who shared a passion for patient-centred research in medicines development. A lot of wonderful work was done in informing clinical trial design and conduct, with an emphasis on patient-reported outcome (PRO) strategies. It is a large company that offers much expertise across many areas, and I was fortunate to learn and contribute a lot in my role as Head of Science & Analytics in the Patient-Centred Solutions team. But I wanted something that was closer to clinical care, that was unburdened by large company policies, procedures and politics, and allowed me access to integrated data to analyse and explore in collaboration with patient organizations, healthcare professionals, and the biopharmaceutical industry.

Vitaccess is a relatively small company. Like IQVIA, it informs clinical trial design and conduct. It also builds patient-focused registries in a scientifically robust way, incorporating patient-level clinical, biometric, patient-reported and healthcare data into single databases. These registries are uniquely able to answer questions to inform medicines development, support regulatory and payer decision-making, and shape routine care delivery. These questions will include:

• What is the natural history, diagnosis experience, and burden of disease for patients with [disease X]?
• Which healthcare services are used in treating [disease X] and how much will it cost?
• What are the prognostic indicators of treatment success for [disease X]?
• What levels of adherence and persistence are seen in treatment for [disease X] and what is the prevalence and seriousness of adverse events?
• How do patients and clinicians perceive the treatment and care that they receive and deliver in [disease X]?
• Do patient experiences of [disease X] differ by geography, culture, or healthcare system?
• Are patient perspectives, clinician perspectives and clinical data aligned when treating [disease X]?

Building research around real patient experience

To support the development and maintenance of registries and to ensure complete and high-quality data to answer such questions, the Vitaccess team comprises quality and compliance professionals, project managers, technology experts, site and patient outreach and engagement managers, scientific researchers, statisticians, and data managers. Since joining, I have enjoyed many discussions about what data should be collected in the registries, how to ensure ongoing participant engagement to maximise data quality and completeness, different statistical approaches to registry data analysis to answer scientific questions, and what (mixed-methods) nested studies could be completed to answer additional questions. I have been impressed with the experience and expertise in the team – in secondary research (e.g. literature reviews to inform PRO selection and strategy) as well as primary research (e.g. qualitative and quantitative research to validate outcome measures, understand patient priorities, preferences and needs, and derive consensus on strategy).

And of course – perhaps most importantly for me – the unwavering focus on patient centricity. The Vitaccess tagline of “patient-centric, science-driven research” arrows right to my heart. And it’s a tagline that people here seem to truly live and breathe – something I am fully embracing.

Patient-centric, science-driven research

Patient-centric registries with integrated data are already important in medicines development. In the past decade, regulators and payers have increasingly recognised their value to support pre-authorisation trial design (e.g. sample size and representativeness of trial populations) and provide real-world experiences on treatment post-authorisation (to monitor effectiveness and safety). Now, clinical decision-makers are getting on board, with observed treatment safety and effectiveness data from routine clinical care and perceptions of care received informing care decisions, service provision, and investment priorities.

The next evolution of patient-centric research

I have been given an opportunity to be a part of this real-world wave and I am like a kid in a candy store! As the new Vitaccess CSO I have three clear briefs:

1. As the company scales, ensure that it continues to focus on collecting high-quality, interpretable, clean, complete, relevant, compliant and meaningful real-world data rather than being tempted by scientifically dubious shortcuts and efficiencies
2. Support the biopharmaceutical industry and its stakeholders, healthcare systems and patient organisations, making use of data to inform decisions about treatments and care
3. Make Vitaccess the go-to partner for like-minded biopharmaceutical firms focused on patient-centric, science-driven research

It’s a long time since I initially qualified as a Practitioner Health Psychologist, but the pull of patient centricity remains as strong as ever.