Lundbeck on Incorporating Patient Insights Into Medicine Development in Brain Diseases

How does your team in Global Value Evidence and Patient Insights help center the patient in Lundbeck’s medicine development? 

Our team is part of the Global Medical Affairs organization and responsible for integrating patient-focused drug development methods across Lundbeck’s development portfolio. In partnership with patient communities, we work on the generation of patient experience data and leveraging patient engagement to center the patient's voice throughout our drug development, not only in how we design our trials, but also in understanding what is meaningful and relevant to patients. For us, by integrating the patient perspective through the evolution of asset development, patient centricity and innovation go hand-in-hand. 

In all of our programs, whether that is in neurology, psychiatry or neuro-rare, we strive to center  the patient voice. That means collaboratively working to understand what is meaningful and relevant to individuals in their daily lives, and translate this to evidence and impact in our drug development -with the ambition that this leads to better treatment outcomes.

How are patient insights introduced and integrated into teams? 

Our team is involved in strategic discussions across projects and also integrated in trial teams to have the operational perspective. We work closely with our advocacy colleagues for patient engagement and intentionally harmonize our evidence generation activities with a variety of stakeholder/ functional needs and decision points, which enables integration of the patient perspective throughout a program's development. 

From a program level, all functions collaborate on the course of action and the types of evidence that we must generate. We are contributing to that conversation by thinking about “What of that evidence could best be answered by the patient's perspective, and how do we do that in the most robust way?” That inclusion is something we’re able to systematically plan for and integrate into as part of a cross-functional team. 

From an individual trial level, as part of the trial team, we are in continuous dialogue to understand shared questions – whether that be the schedule of events, length of visit times, types of assessments, inclusion/exclusion criteria – and how we can bring forward the patient perspective to inform that. 

"We work on the generation of patient experience data and leveraging patient engagement to center the patient's voice throughout our drug development, not only in how we design our trials, but also in understanding what is meaningful and relevant to patients."

How have you seen the work that you do change, influence or inform the research process? 

We firmly believe that patient engagement and the integration of patient experience data leads to better treatments. This has led to a broader understanding that opportunity and patient-centricity exist hand-in-in when incorporated early and throughout a drug development program.  But it also creates value by saving time and resources, while making our efforts even more relevant, impactful and meaningful to all involved. And I think that’s something we all share – wanting to be involved with or contributing to efforts that are impactful to patient lives

How are you innovating in patient data and RWD?

The HEAD-WINd® project in headache and migraine is a great example of our innovation through centering the patient perspective. Initiated in private-public research partnership with the Danish Knowledge Center on Headache Disorders, as well as collaboration with the patient associations Danmarks Patientforening for Hovedpineramte, Migraine Denmark and the Migraine and Headache Association, the HEAD-WINd® project involved about 100,000 adult Danes. 

This research project is an innovative methodology for gathering data about the daily experiences of individuals living with frequent headaches and migraines, as well as integrating this ‘real-world data’ with existing registry data in Denmark. Not only will this benefit the scientific research – it will also lay a solid foundation for innovation: It will increase our understanding of headaches and migraines, contribute to the development of evidence-based improvements for future treatments within the healthcare system, and shed light on new methods for generating evidence in the future.

“What of that evidence could best be answered by the patient's perspective, and how do we do that in the most robust way?” 

What were the goals of the project? 

A key goal was to understand motivations and considerations for participating, and specifically for voluntarily self-reporting disease experience in a day-to-day context. From qualitative interviews as part of our user research, we learned that persons living with migraine wanted to support science and that this was a key motivator for participation. This shifted our thinking from “what can we get” as researchers towards “what can we give” the study participants, in terms of better understanding the science that they are supporting through their research participation.

This understanding informed both the app used in the study for prospective data collection, as well as the messaging across all patient-facing materials, including the recruitment materials, study invitation letter and the consent form. In addition to the interface for collection of data, the app included videos about the study, articles explaining the science and assessments (PROs) and a regular newsletter discussing the progress of the study.

What other work are you doing to connect with patients and educate about clinical trials? 

It's very important to involve patient communities in communication about clinical research – how clinical trials inform and make possible new treatments that are safe, effective and lead to meaningful outcomes. The more that we can explain this in a way that is understandable and anchored in understanding people’s everyday lives, the more we can engage a broader audience in the importance, safety and robustness of scientific research.

Specifically, for working in brain diseases, there is often a significant amount of stigma surrounding neurologic, psychiatric and neuro-rare conditions. It’s important to share scientific information in a way that is as digestible, relevant and engaging as possible. We hope it reaches people who are eligible to participate in our clinical trials, but we also hope that broadly it creates an understanding of what it is like to live with a brain disease and how important it is to create relevant and meaningful treatments. 

"The more that we can explain this in a way that is understandable and anchored in understanding people’s everyday lives, the more we can engage a broader audience in the importance, safety and robustness of scientific research."

What is your broader mission as you continue to elevate the patient voice in medicine development? 

Starting drug development from the patient perspective and integrating this understanding throughout is the key to innovative treatments. It is only going to become more complicated to develop novel, relevant therapies, and the more we can try to understand the everyday lives of patients and incorporate that understanding into our work, the more meaningful the outcomes and the more impactful our therapies will be. 

The patient perspective is as important as any other stakeholder perspective we incorporate into drug development. I’m excited to see an ever-growing, shared understanding amongst colleagues and external stakeholders that patient engagement and patient experience data create tangible value to new treatments. But we still need to do more – for example more systematically involve patients in the design, execution and publication of clinical and PED research. I will continue supporting the evolution in the use, methods and impact of patient experience data, with the ambition that these will evolve to be broadly accepted as equally critical and robust as other clinical assessments in drug development.

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