Matt Wilson, Founder and CEO, uMed

The landscape of obesity treatment is undergoing a profound transformation, driven by the advent of entero-pancreatic hormone-based therapies such as GLP-1 receptor agonists. These groundbreaking treatments have introduced a new era of obesity pharmacology, offering unprecedented efficacy in weight management and metabolic health. However, as we enter this new phase, it becomes increasingly evident that a deeper understanding of long-term clinical outcomes is imperative. This necessitates an evolution in how we conduct research to truly grasp the impact of these therapies.

One of the most pressing challenges in this field is the need for robust evidence that accurately reflects the diverse patient populations affected by obesity. The prevalence of obesity continues to rise globally, affecting millions of individuals with varying comorbidities, disease stages, and socio-economic backgrounds. To ensure that emerging therapies like GLP-1 receptor agonists are both safe and effective across all subgroups, we must go beyond the limitations of routinely collected data.

The need for comprehensive data collection

Existing Electronic Medical Records (EMR) and claims databases, such as HealthVerity, Truveta, and the UK’s Clinical Practice Research Datalink (CPRD), offer rich datasets drawn from large populations. These sources are invaluable for analyzing trends and outcomes within the parameters of routinely collected data. However, they fall short when it comes to capturing the nuances of the patient journey, particularly in understanding the real-world effectiveness of new therapies within different sub-populations.

To address these evidence gaps, it is essential to develop mechanisms that can build large patient cohorts, allowing for academically rigorous data collection that can enrich data that is routinely collected. This includes the integration of patient-reported outcomes (PROs), device-generated data, and even biosamples. Such an approach would provide a more comprehensive view of patient experiences and outcomes, enabling researchers to conduct subgroup analyses that identify differences in response among patients with various comorbidities and therapy combinations.

Innovating real-world research

To overcome the limitations of traditional research methodologies, we must adopt a more integrated approach that combines the strengths of real-world data with patient-generated insights. Rather than simply trying to collect every possible data point from a cohort, this approach focuses on the strategic gathering of relevant data, addressing the specific needs of researchers and ensuring that relevant patient subgroups are adequately represented. By enhancing existing EMR and claims databases with prospective data collection, we can create a more detailed and accurate picture of obesity treatment outcomes.

This innovative research model allows for the development of large, diverse patient cohorts, facilitating the identification of varying responses to GLP-1 receptor agonists across different patient populations. It also enables researchers to address complex questions that go beyond the capabilities of traditional registry models, ultimately leading to a more nuanced understanding of obesity therapies.

The path forward: benefits for pharmaceutical manufacturers

As we move forward in this new era of obesity pharmacology, the integration of real-world data with patient-generated insights presents significant advantages, particularly for pharmaceutical manufacturers. This approach accelerates the generation of robust evidence, which is critical for driving discussions with health technology assessments (HTAs), payors, and physicians. By providing detailed, real-time insights into the effectiveness of new therapies across diverse patient populations, manufacturers can more effectively demonstrate the value of their products in the context of a complex patient population that often have multiple comorbidities and are a variety of therapy combinations.

The challenges in obesity research are significant, but the opportunities for innovation are equally profound. By embracing a more integrated, real-world approach to data collection, we can ensure that the next generation of obesity treatments is both effective and widely adopted. This not only advances the field of obesity pharmacology but also drives the broader goal of improving public health, while delivering substantial benefits to pharmaceutical manufacturers in the form of faster, more informed market penetration.

Matt Wilson, Founder and CEO, uMed