The pharma industry has been talking about being patient-centric for years, but often that rhetoric hasn’t been accompanied by real change in the way product development is carried out.
Keri McDonough thinks there is still a void between some pharma and patients, but one that can be bridged by developers who make a commitment to incorporate patient insights at scale across their operations.
Listening to patients. It’s a phrase that’s been repeated so often and for so long by the pharma industry that it surely must be deeply ingrained in its culture, but McDonough says the sentiment –while sincere– doesn’t always match the reality and has lost meaning.
Through her role as head of the Patient Voice Consortium at Syneos Health®, McDonough has seen first-hand how pharma companies large and small have attempted to build patient-centricity in the development programmes, with varying results.
One problem is that the term patient-centricity has started to lose its meaning, becoming a buzzword that is used without really thinking about what it means. And that was part of the thinking behind naming the Patient Voice Consortium, which has been set up to make sure patient perspectives and partnerships are included throughout the drug development and commercialisation process.
So why is that so important? Firstly, patients are increasingly empowered and knowledgeable about their illness, many with free access to resources and the motivation to seek out and connect with peers, and pharma companies need to respond to that trend. Healthcare systems meanwhile are recognising that well-informed patients need to be represented in decision-making and that therapies should be designed around their needs.
Incorporating patient perspectives in the product development and commercialisation process also increases the chances that a programme will be successful – for example by improving the design of clinical trials, encouraging enrolment and retention of trial participants, and making sure the patient pool is representative of what is seen in the real world.
This goes beyond seeking out patient stories to inspire employees – something almost all pharma embraces for good reason. It comes from asking a diverse mix of patients what would make trials and other activities more meaningful and accessible to them and from involving the patient advocacy community early on.
“There’s a difference between listening to the patient voice to pressure-test an almost baked idea versus creating the infrastructure and timelines necessary to allow patient perspectives to guide you,” says McDonough.
“It’s not like you can just say, ‘okay, we listened to the patient voice, check. Now we’re done. We can move on to something else.’ It has to become part of the way that we do business across the board.”
The industry overall is making progress. Syneos Health and its Patient Voice Consortium have seen firm evidence that some of the bigger pharma companies have gone from piloting patient-centricity to “operationalising” their patient-focused work – in other words, having patients along the way for the entire journey through commercialisation.
At the other end of the spectrum, there has been amazing work by smaller, often rare disease-focused companies with close ties to patient communities, although that may not necessarily scale.
It’s in the middle ground of small- to mid-size companies not focused on rare diseases where there is still a lot of variability and room for improvement, according to McDonough, and some still think of the healthcare professional as their customer, not the patient. There’s clear evidence of a shift in thinking though – which can be seen by the number of companies in pharma that are hiring and scaling up their patient advocacy and patient engagement teams.
Likewise, patients and advocacy groups are diverse in many ways, including their ability to engage with medicine developers. Some may simply not be equipped to have conversations about the entire treatment landscape and where the gaps are.
Others want to be deeply involved and can go toe-to-toe with any key opinion leader (KOL) or industry expert in a disease area and are often more knowledgeable when it comes to cost and affordability.
“We can’t only connect with folks who are most engaged without also trying to understand what’s happening to those that aren’t as vocal,” according to McDonough. While advocacy groups are increasingly industry-savvy, some may still need help and expertise into the mechanics of drug development, regulation, commercialisation, and market access. Others may even still be opposed to working with industry altogether, which can pose an engagement challenge.
The clear need for greater collaboration is being seen in the regulatory environment as well. The FDA has been developing Patient-Focused Drug Development guidance documents to help incorporate the patient’s voice in medical product development and regulatory decision making, for example, and has set up a Patient Engagement Collaborative (PEC) that exchanges ideas and expertise with other regulators, including the EMA in Europe.
It’s a complex task, and navigating those complexities of the process is where the Patient Voice Consortium comes in. The group has been built from the ground up with people who understand the needs of patients, and how to work with them in areas such as clinical trial design, operations, stakeholder education and access to care.
Acting as a hub, it brings together Syneos Health’s therapeutic knowledge and expertise across advocacy and engagement, drug development, behavioural and social science, patient-reported outcomes and registries, regulatory compliance, and health policy.
Overall, the aim is shortening the distance from lab to life® in other words taking scientific discoveries and bringing them forward as quickly as possible so they can bring benefits to patients.
“We need to demonstrate that we’re listening to the patient voice, not just talking about it,” says McDonough. “We need to move on, and chip away at the mindset and operational barriers that prevent routine and strategic patient input across the business.”
That includes a clear understanding of and adherence to health literacy principles – defined as the degree to which individuals can find, understand, and use information and services to inform health-related decisions and actions, either for themselves or others, which is one of the Consortium’s current priorities along with working on ways to ensure diversity in trials.
When it comes to health literacy, the onus isn’t just on the recipient of the information, and one thing that developers can do is work to make sure that the recipient – the patient or caregiver – is set up to succeed by having the skills and understanding needed to advocate for themselves and their communities. Community-based and disease specific health literacy programs can help here, along with universal glossaries designed by and for patients.
Many in the industry also need to be more cognizant of how disease and life circumstances may impact a patient’s willingness to participate in a trial or even the likelihood that a physician will bring up research options. Socioeconomic status, race, education, disease status, and history with prior treatments are all factors that can affect a patient’s consideration of a clinical trial or a new medicine.
Recognising the disparities in access to digital technologies, transportation or centres of excellence can guide operational decision-making in trials, such as whether to use a decentralised design or have systems for delivering therapies directly to patients in their homes rather than at centralised sites.
That includes being inclusive about who you engage with, and not just listening to those that are on board with your plans – don’t ignore the dissenting voices, and those of individual patients who are not experienced advocates.
The Patient Voice Consortium can help pharma by connecting the dots – providing the insights, tools, frameworks and early-adopter best practices that embed thinking about patients at that operational level throughout the drug development lifecycle, according to McDonough.
Part of that is figuring out the mechanics of the process – when to start and stop engagement, how to equitably renumerate patients, setting the right cadence for interactions, and budget and headcount considerations, for example – but also understanding how to adapt the approach where necessary.
Top tips are to start engagement early, making sure you have access to relevant expertise, as well as clarity on who is responsible and accountable for bringing the patient voice to the table.
It still happens that pharma companies only start thinking about patient engagement when a product approval is around the corner, says McDonough. Sometimes that’s because they think of patient advocacy groups as a channel – a way to push out information that doesn’t take into account the benefits of two-way communication with patients.
Overall, there’s no one-size-fits-all or universal playbook for making sure that the patient voice is heard in the development of medicines, but it is possible to close the communication gap between patients and developers, says McDonough.
“If you can understand the outer edges of a patient community and understand where there are commonalities, then you are more likely to develop the best programme or drug possible.”
Keri McDonough heads up the Patient Voice Consortium at Syneos Health. Keri has integrated patient perspectives across therapeutic areas for nearly two decades with the goals of improving patient experience and outcomes. Keri’s approach is framed around surfacing ways to chip away at barriers and biases that limit patient-focused innovation, including lack of inclusion, equity and access, health and digital literacy gaps and inaccurate or incomplete representation of stigmatized or marginalized patient communities.
Keri has spearheaded ground-breaking patient and caregiver programs in multiple therapeutic areas and is fluent in the tools and principles underpinning the science of patient input. Keri joined Biosector 2, a Syneos Health communications agency, in 2013 after approximately ten years within the WPP network. Keri’s patient advocacy efforts began leading communications at the New York City Chapter of the National Alliance for Mental Illness. Prior to healthcare, she led marketing at The Union Square Partnership, a multi-stakeholder economic development organization. Keri holds a BA in sociology from Tulane University and a MA from University of Oregon’s School of Journalism with an emphasis on the role of communications in social movements.
Syneos Health® (Nasdaq: SYNH) is the only fully integrated biopharmaceutical solutions organisation. The company, including a contract research organisation (CRO) and contract commercial organisation (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry-leading companies – INC Research and inVentiv Health – it brings together approximately 27,000 clinical and commercial minds to help its biopharmaceutical customers shorten the distance from lab to life.
The Syneos Health Patient Voice Consortium is a hub of expertise, resources and relationships designed to ensure the strategic incorporation of patient perspectives throughout the drug development and commercialization process. The Patient Voice Consortium facilitates a cross-functional approach to understanding the real world needs of patients and pressure-testing, problem-solving and co-creating to maximize impact. Given the well-documented disparity in voice and care among marginalized patient populations, the Patient Voice Consortium seeks to connect with and learn from the widest range of patient communities possible using inclusive methodologies rooted in transparency, shared purpose, and bidirectional communications.