Enhancing Lupus Clinical Trials with Real-World Data Sources

Enhancing Lupus Clinical Trials with Real-World Data Sources

To learn how clinical trials for lupus can be enhanced with real-world data sources, we spoke with Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center (left) and Frederico Calado, VP of Global Real-World Solutions at Alira Health (right).

Lupus, a complex autoimmune disease, has brought a substantial challenge to researchers and healthcare professionals. Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years. In this pursuit, the importance of real-world data (RWD) in advancing lupus solutions cannot be overstated.

RWD is a critical asset in lupus research, offering a thorough view of the disease’s complexities. Lupus varies widely among patients, and understanding this diversity is challenging. RWD provides valuable insights by:

  • Capturing diverse patient experiences, including symptoms, treatment and quality of life
  • Assessing long-term treatment effectiveness and safety, vital for lifelong management
  • Encompassing diverse patient populations, addressing disparities in care
  • Incorporating social determinants of health, which influence treatment access and outcomes
  • Bridging clinical trials and real-world practice, ensuring applicability
  • Prioritizing patient-reported outcomes for patient-centered research
  • Supporting continuous improvement in lupus management

And more. In essence, RWD empowers researchers, healthcare providers and patients to better understand and manage lupus, leading to improved care and outcomes.

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health, and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center.

Read on to explore why companies should consider including RWD for their lupus solution development. Calado and Dr. Michaud also discuss the exciting partnership between Alira Health, FORWARD — the National Databank for Rheumatic Diseases — and sponsor companies aimed at benefiting lupus patients.

RELATED XTALKS WEBINAR: How to Accelerate Lupus Solutions with RWD

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Register for this free webinar to explore lupus solutions and real-world treatment impacts through a discussion on patient aspects and the role of technology in streamlining research efficiency.

What is the role of RWD in developing lupus solutions?

Dr. Kaleb Michaud: In developing lupus solutions, RWD plays a crucial role. It’s essential to understand the effectiveness of the many treatments emerging from the randomized, controlled clinical trial pipeline, especially since lupus is so complex and many therapies are used off-label.

RWD is important in understanding the current impact of lupus on patients and the disease’s burden. This includes quality of life measures, healthcare utilization, comorbidities and the involvement of healthcare professionals beyond rheumatologists. Additionally, it involves understanding the broader context of a lupus patient’s life, including socioeconomic factors and issues affecting medication adherence.

Why should companies consider accessing RWD for their solution development?

Frederico Calado: Companies should use RWD throughout the drug lifecycle, starting with informing clinical development plans. RWD can enhance the efficiency of randomized controlled trials by providing insights into the medical, economic and humanistic burden of diseases. This helps in understanding not just the clinical impact of a treatment but also its quality of life implications for patients and caregivers and the economic impact for healthcare systems.

Beyond initial development, RWD is important for generating early insights on new therapies and solutions, especially since randomized controlled trials don’t always represent the broader population who will use the drug. By studying a wider group, companies can make more informed decisions which ultimately leads to improved patient outcomes.

Dr. Kaleb Michaud: RWD is crucial, especially in lupus, where few drugs have been approved by the US Food and Drug Administration (FDA) over decades. Recent approvals were based on clinical trials with a small, tightly controlled patient group to demonstrate efficacy. However, once approved, these drugs are used by a broader lupus population, leading to gaps in understanding about their general effectiveness.

RWD is essential not just for monitoring safety (pharmacovigilance) but also for understanding the broader impacts on quality of life. Given the high costs and access challenges of these treatments, leveraging RWD can provide a more comprehensive understanding of their real-world performance and benefits, guiding better treatment solutions and access strategies.

What kind of sources can provide RWD for Lupus solutions? 

Frederico Calado: Typically, people turn to therapy area-agnostic claims and clinical databases for observational data, which offer a broad overview of diagnoses, interventions and outcomes. However, these sources often lack the depth necessary for conditions like lupus, missing key details such as symptoms, quality of life and social determinants of health (e.g., race/ethnicity, education, economic status). These databases also typically miss critical information like genomic and molecular data.

For in-depth clinical research, especially in complex areas like lupus, it’s crucial to seek out specialized and therapy area-specific data sources. These are designed from the very beginning to capture comprehensive information, including not just clinical but also social, economic and genomic/molecular factors. A lupus registry, for instance, would likely provide much more relevant and detailed data than the so-called “generic” databases, enhancing the utility and precision of the research.

Dr. Kaleb Michaud: Administrative datasets are useful for pharmacovigilance, tracking billing, hospitalizations and emergency visits, but they often miss the severity of the disease and may not confirm accurate lupus diagnoses. While they’re good for identifying safety signals, they lack depth in capturing patient experiences.

Existing patient registries, typically tied to academic institutions or specific clinics, provide selected data about participants but exclude many lupus patients not attending these facilities.

For the registry by FORWARD and Alira Health, we access patients where they live, offering a more comprehensive view of the lupus experience. Each RWD source has its advantages and limitations; however, the lupus registry we’re revamping gathers extensive information about the patient experience, with a much larger in-depth record and variables collected. This offers a deeper understanding beyond what administrative or clinic-focused datasets can give.

Alira Health and FORWARD have recently partnered for a lupus registry. Can you please tell us about this initiative?

Dr. Kaleb Michaud: The FORWARD Databank, established in 1998 by a private rheumatologist, was created to overcome the limitations of clinic-based cohorts and understand the broader patient experience across the country. It’s evolved from sending biannual questionnaires to patients into a more tech-forward, patient-centric research nonprofit. Recognizing the need to reach younger, socioeconomically disadvantaged lupus patients often missed in traditional systems, we’re shifting to a more flexible, smartphone-based approach for data collection and patient engagement.

This new model, in partnership with Alira Health, aims to capture real-time experiences of a wider lupus population, including those who are outside conventional administrative datasets due to lack of insurance or healthcare access. This collaboration with Alira Health will evolve FORWARD’s methods, enhancing our ability to collect valuable, comprehensive data on lupus patients’ lives and experiences.

Frederico Calado: Alira Health, a global advisory and clinical research firm, recognized the opportunity to enhance observational research by partnering with FORWARD, which has a long-standing history of effectively collecting and managing patient data. We aim to strengthen the value of the lupus registry by engaging Alira Health’s comprehensive services, ranging from clinical to commercial consulting.

Our plan includes employing our patient-facing software to streamline data collection, implementing strategies to boost patient enrollment, engagement and retention, and re-evaluating lupus assessments with external stakeholder input, particularly from life sciences companies. This partnership is also about enhancing the registry’s external perception and boosting data utilization by leveraging Alira Health’s extensive network in the life sciences sector.

The collaboration between Alira Health and FORWARD is expected to deliver substantial synergies in various areas over the next few years. We’re also keen on exploring collaborations with other lupus data holders and not-for-profit organizations.

How can the partnership between Alira Health, FORWARD and sponsor companies create a synergy that will benefit lupus patients?

Frederico Calado: The partnership aims to create synergies by focusing on meritable observational research projects to advance our understanding of lupus and accelerate the discovery, approval and access to new treatments. Research sponsors will have the opportunity to accelerate and refine research by tapping into extensive longitudinal data and a robust recruitment channel for prospective studies (observational and interventional). This resource will enable them to explore new hypotheses and capture long-term outcomes. This approach empowers sponsors to assess the current disease burden and generate evidence on the impact of new and established treatments in a highly efficient way.

By establishing the lupus registry as a premier data source and investing in its improvement and maintenance, we expect to generate a wealth of data and insights. The results of data reporting will be shared with the members of the patient registry, allowing patients to gain insights into the collective outcomes experienced by the population with lupus. Furthermore, all research findings that are published will be disseminated to the lupus community, giving them the opportunity to understand the role of the registry in fostering groundbreaking discoveries. This, in turn, will raise awareness of this unique resource, setting in motion a virtuous cycle benefiting patients, researchers, sponsors and eventually payers and regulators.

The goal is to continuously enhance the quality and diversity of research, to add value to the entire lupus stakeholder ecosystem and ultimately help lupus patients.

Dr. Kaleb Michaud: The partnership leverages Alira Health’s expertise in creating patient communication ecosystems, complementing our research goals at FORWARD. We’re particularly excited about reaching socioeconomically disadvantaged groups and those of Native American and African American descent, who are disproportionately affected by lupus and often overlooked in clinical trials and registries. Alira Health’s technology facilitates access to these patients in their environments, notably through an engaging mobile experience co-designed for patients and with patients, and enhances record-keeping for more robust research.

This collaboration aims to validate and create better measures that resonate with lupus patients, focusing not just on maintaining stability but also on improving their condition. We hope this partnership will lead to more responsive and effective treatments, offering new hope and options for lupus patients.

For more insights into RWD sources for lupus clinical trials, be sure to register for the free, upcoming webinar.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.