Patient advocacy groups can be a powerful resource for pharmaceutical companies and their research partners. However, such organizations often are short on the resources they need to collaborate with other stakeholders and make their voices heard.
It is possible for patient groups to make the most of it by putting in place a well-thought-out strategy. To learn more, Outsourcing-Pharma connected with two experts from IQVIA:
- William Lawrence, senior director of non-profit organizations for IQVIA Healthcare Solutions
- David Voccola, senior director of global strategic planning for IQVIA Integrated Health Practice
OSP: Could you please talk about the relationship sites and sponsors traditionally have had with patient advocacy groups?
IQ: While many patient advocacy organizations have excellent working relationships with the sites and sponsors caring for their respective patient communities, the formal relationships between patient advocacy organizations and sites and sponsors have traditionally been at arm’s length. At the site level, patient advocacy organizations often serve as conveners of key opinion leaders (who are typically employed at sites). They may fund non-profit or investigator-led research initiatives at their sites, such as disease registries and natural history studies. Some patient advocacy organizations have also established Centers of Excellence programs that seek to guide patients and sponsors to engage with participating sites that demonstrably meet the patient advocacy organization’s qualifications for delivering expert care to the relevant disease populations.
Patient advocacy organizations’ relationships with sponsors have traditionally focused on patient insights and sharing details on available clinical trials, with most patient advocacy organizations embracing grants from and/or non-exclusive collaborations with sponsors developing therapies for their disease areas of interest. These collaborations range from patient education efforts to the patient organizations actively engaging in clinical research and/or post-marketing activities, which can include services to support protocol design and patient recruitment, or through the sharing of data from the patient organization’s patient health data initiatives.
In the wake of the 21st Century Cures Act in the US, some patient advocacy organizations have begun adopting patient health data technologies and methods conducive to facilitating real-world studies and even long-term follow-up on novel cell and gene therapies. This has helped to further advance the relationship between patient advocacy organizations and sponsors from one of loose collaboration to direct partnership in the mission to accelerate access to life-changing treatments.
OSP: Please tell us your perspective on the interests of sites/sponsors, and patient advocacy organizations, including areas in which their interests align and places where they might differ or conflict.
IQ: The interests of patient advocacy organizations and sponsors have increasingly converged over the past decade, driven by a combination of sponsors seeking to leverage patient-centric research designs to improve patient recruitment and retention, and regulators now requiring five-, 10-, and even 15-year follow-up periods for which traditional site-based monitoring is not well suited. Patient advocacy organizations have deep experience with both patient-centric engagement and long-term longitudinal data collection and have been some of the earliest adopters of patient-mediated data sharing models, making them ideal partners for sponsors navigating today’s research environment.
The same external factors bringing the interests of patient advocacy organizations and sponsors closer together are having the opposite effect on the interests of patient advocacy organizations and sites. While it was the center of gravity for clinical research and patient health data initiatives, sites are now navigating the uncharted waters of a post-Cures Act America, in which patients themselves—not the healthcare professionals or facilities providing their care—own and control access to patient data.
In this new model, patients can not only complete patient-reported outcomes (PROs) and other forms of clinical outcome assessments (COAs) but can also mediate the direct sharing of their electronic health information (EHI) from electronic health records, administrative claims, consumer wearables, and medical devices via a computer or smartphone using dedicated, federally mandated application programming interfaces (APIs). Almost overnight, patient advocacy organizations with modern patient health data infrastructures can now access the majority of real-world data that used to only be available by engaging clinical sites, lessening the reliance of both patient advocacy organizations and sponsors on sites and networks, and accelerating industry trends towards more hybrid and decentralized research designs.
OSP: Please tell us specifically about some of the challenges nonprofits and advocacy groups face.
IQ: Funding is the most consistent challenge faced by the advocacy community. The global pandemic hit the non-profit community particularly hard, with some organizations experiencing revenue shortfalls of 50% or greater in 2020 and 2021 due to declines in private donations, volunteers, conferences, and fundraising events. And even those with adequate funding have experienced (positive) challenges related to operationalizing their newfound abilities to engage in patient health data initiatives at greatly increased scales and sophistication. Additionally, funding challenges impact the prioritization of compelling initiatives that would benefit patient advocacy communities, along with bandwidth and staff capacity.
OSP: You talk about forming a strategy for dealing with patient advocacy groups. Could you please talk about some of the considerations, and the components of a successful strategy?
IQ: While there is no single solution for all patient organizations, the convergence of advocacy, healthcare delivery, and life sciences use cases makes our team, which sits at the intersection of these areas, uniquely positioned to drive innovation, share best practices, and engage patient organizations regardless of their budget or organizational maturity.
Specifically, we seek to ensure every patient advocacy organization understands the new technical and regulatory landscapes in which they operate, the new opportunities afforded by their relationships with patients, and the unprecedentedness of this moment in US healthcare. Focusing on empowering patient advocacy organizations to develop informed strategies, rather than simply selling them a pre-canned solution, enables them to leverage this moment to grow their role, relevance, and revenue in ways that further accelerate their missions.
OSP: Can you share any examples of a study team forming a great relationship with a nonprofit/advocacy group?
IQ: Traditionally, study teams leveraged a patient organization to help with protocol development or patient recruitment, often late in the game. What is most exciting are the nascent relationships now forming between sponsors, CROs, and non-profits that have begun investing in modern health data infrastructures. These non-profits are embracing their expanded roles as true partners in the clinical research and care delivery ecosystems.
One great example is the American Society of Hematology Research Collaborative’s Sickle Cell Disease Clinical Trials Network, which is set to generate a 360° view of the health journeys experienced by sickle cell patients—from both the provider and patient perspective—and accelerate therapy development for hundreds of thousands of sickle cell patients in the U.S. and around the world. There are similar initiatives being planned or already underway by IQVIA’s other medical specialty society partners.
Our patient advocacy partners have been even quicker to adapt to the new landscape, with The Multiple Myeloma Research Foundation’s CureCloud initiative being one of the innovative research initiatives to launch in the past decade. And we are thrilled to see the new relationships forming between researchers and patient advocacy organizations with our partners in neuromuscular, nephrology, and other disease areas, as these teams employ their next-generation data infrastructures to provide valuable new services to life science partners.
OSP: Then, can you share any potential pitfalls to avoid?
IQ: The current landscape contains more opportunities than pitfalls for forward-thinking organizations looking to partner on research endeavors, but pitfalls do remain. For sponsors, it can be difficult to evaluate the true capabilities of a patient organization to provide research-grade data service, especially given many of these capabilities will be new; misjudging these capabilities can just as easily result in missing an opportunity for a mutually beneficial relationship than in a failed collaboration, so it is important to have one of the (admittedly few) subject matter experts in these new collaboration models help evaluate potential matches.
Likewise, it can be difficult for patient advocacy organizations to know which combination of services to offer, evaluate their operational readiness, and determine price points. In these cases, it can be beneficial to partner with an established CRO to ensure the patient advocacy organization’s services are embedded holistically into a professional offering to minimize the risk to both the non-profit and the sponsor.
OSP: How can IQVIA help?
IQ: IQVIA is uniquely positioned to help in many ways. As a global CRO leader, our experts sit at the intersection of international research, non-profits, and healthcare delivery models with unprecedented line of sight into the emerging capabilities, best practices, and trends affecting our vast portfolio of customers and the patient communities they serve. This purview enables IQVIA to provide expert guidance to our partners as they explore new ways to engage patients, while simultaneously ensuring they have the technologies and methodologies needed to do so successfully today and in the future.
OSP: Can you please share a bit of detail about what the Registry Center of Excellence is and what it does?
IQ: IQVIA’s Registry Center of Excellence is a thought leadership and consulting organization focused on ensuring partnerships between non-profits, sites, CROs, and sponsors are not rate limited by mismatches in legacy expectations or definitions. It is closely aligned with IQVIA’s Integrated Patient Experience division and offers various services, including registry capability reviews, registry data science, regulatory alignment, sustainability modeling, and research planning. All services are highly targeted and tailored to each client and are designed to reduce the blockers limiting or delaying successful program implementation.