Steatotic Liver Disease Patient Cohorts
Integrated Retrospective and Prospective Data to Power Evidence Generation in Complex Liver Conditions
Evidence-Driven Innovation Across MASLD, MASH, ALD, and MetALD
At Target RWE, we understand the immense challenges and critical need for innovation in the complex landscape of Steatotic Liver Diseases (SLD)—encompassing conditions like Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Metabolic Dysfunction-associated Steatohepatitis (MASH), Alcoholic Liver Disease (ALD), and Metabolic Dysfunction-associated Alcoholic Liver Disease (MetALD). Leveraging our expansive history and deep expertise in real-world evidence within hepatology, we build comprehensive patient cohorts designed to empower pharmaceutical partners in accelerating their drug development programs.
Foundation Patient Cohorts for SLD Research
We’ve pioneered a more modern vision for clinical evidence generation. Our unique model seamlessly integrates both retrospective and prospective data collection, creating robust, fit-for-purpose patient cohorts. This approach moves beyond fragmented data to provide complete patient journeys, delivering the comprehensive, high-quality insights necessary for pharmaceutical drug development in SLD. Our foundational SLD cohorts allow us to deliver:
MASLD & MASH Cohort
Navigating Complexity from Silent Progression to MASH Resolution
The silent progression of MASLD, the reliance on invasive biopsies for MASH diagnosis, and the variability in patient phenotypes create significant hurdles for drug developers. Our MASLD and MASH cohort provides robust longitudinal data capturing every facet of the patient journey, from initial diagnosis through progression to advanced fibrosis. This includes granular electronic health records, comprehensive lab results (including specialized metabolic panels), detailed liver imaging (vibration-controlled transient elastography (FibroScan®), ultrasound, CT scan, MRI), and invaluable liver biopsy pathology data. This rich dataset empowers partners to optimize clinical trial feasibility, assess clinical outcomes, validate crucial biomarkers for non-invasive diagnosis and response, and build sophisticated progression models to accelerate therapeutic development for MASH.
Identify and precisely characterize MASH/MASLD patient populations for clinical trials, leveraging detailed biopsy and imaging data to optimize inclusion/exclusion criteria, understand the natural progression of disease and clinical event rates and inform site selection for specific fibrosis stages or metabolic profiles.
Validate novel non-invasive biomarkers for MASH diagnosis, disease progression, and treatment response, utilizing comprehensive longitudinal lab and imaging data alongside noninvasive measures and liver biopsy test results.
Develop predictive models for MASLD/MASH progression from steatosis to advanced fibrosis and cirrhosis, integrating longitudinal clinical, lab, imaging, and pathology data to anticipate patient outcomes.
Generate compelling evidence on the effectiveness and safety of MASH therapies in diverse, real-world patient populations, capturing long-term outcomes not typically seen in controlled trials and among understudied populations.
Precisely characterize distinct MASLD/MASH patient subgroups based on patient characteristics such as metabolic profiles, fibrosis stage, noninvasive assessments, genetic markers, and response to lifestyle interventions, informing targeted therapy development.
Fulfill regulatory requirements by providing robust, long-term real-world data on product performance, safety, and effectiveness in the broad MASLD/MASH patient population post-launch.
Pinpoint ALD patient cohorts based on severity, alcohol consumption patterns, and comorbidities, streamlining recruitment for trials targeting various stages of alcoholic liver disease.
Discover and validate biomarkers specific to ALD progression, response to therapies, and risk stratification, leveraging detailed alcohol consumption data and clinical outcomes.
Construct robust models to understand the natural history and progression of ALD, accounting for variable alcohol exposure and associated comorbidities to predict outcomes and identify risk factors for decompensation.
Assess the real-world effectiveness and safety of interventions for ALD, considering varied patient adherence, comorbidities, and healthcare utilization patterns.
Identify specific ALD patient phenotypes (e.g., acute alcoholic hepatitis, compensated cirrhosis) based on clinical presentation, alcohol use, and comorbidity burden, enabling more personalized approaches.
Generate real-world evidence for regulatory submissions and post-marketing commitments for ALD therapies, reflecting real-world prescribing patterns and patient outcomes.
ALD Cohort
Unveiling Insights in a Multifaceted Disease
Research in ALD is complicated by the nuanced nature of alcohol-related damage, significant comorbidities, and the challenge of accurately capturing alcohol consumption patterns alongside clinical outcomes. Our ALD cohort goes beyond standard clinical data to provide insights into disease progression in the context of alcohol exposure. We have the ability to capture detailed information on alcohol consumption patterns, duration, and abstinence, alongside extensive clinical outcomes, lab markers of liver injury, and comorbidities. This allows drug developers to better understand disease heterogeneity, assess treatment effectiveness in real-world ALD populations, and identify targets for disease modification across the spectrum of ALD.
MetALD Cohort
Deciphering Dual Etiology
The emerging understanding of MetALD, a dual-etiology condition with MASLD and increased alcohol intake, demands an integrated view of both cardiometabolic risk factors and alcohol use. Our MetALD cohort offers a unique integrated dataset that bridges these critical factors. We meticulously collect data points enabling the precise phenotyping of MetALD patients, from cardiometabolic comorbidities (obesity, diabetes, dyslipidemia) to detailed alcohol history, alongside comprehensive liver health outcomes. This cohort is invaluable for disentangling the complex interplay of these etiologies, supporting biomarker discovery and developing targeted therapies for this distinct patient population.
Characterize MetALD patient populations by integrating cardiometabolic risk factors with alcohol use, enabling patient stratification for clinical trials investigating this complex dual etiology.
Identify and validate biomarkers that reflect the unique interplay of metabolic dysfunction and alcohol exposure, aiding in differential diagnosis and monitoring therapeutic efficacy in MetALD.
Build sophisticated models that disentangle the contribution of cardiometabolic risk factors and alcohol to disease progression in MetALD, enhancing prognostic capabilities and informing therapeutic strategies.
Evaluate the real-world impact and safety profiles of therapies for MetALD, providing crucial insights into treatment efficacy for patients with combined metabolic and alcohol-related liver injury.
Characterize unique MetALD patient populations by integrating detailed cardiometabolic and alcohol-related factors, supporting a deeper understanding of disease mechanisms and personalized medicine strategies.
Support regulatory and post-marketing needs for MetALD therapeutics by providing comprehensive real-world data on patient characteristics, treatment patterns, and outcomes in this complex, dual-etiology condition.
Our Legacy of Scientific Rigor and Impact
Target RWE's expansive history in Liver Disease research, marked by a decade of rigorous data collection and scientific leadership, ensures that our cohorts are not just data repositories, but dynamic engines for discovery. Our epidemiological expertise allows for regulatory-grade analytics, sophisticated trial enrichment, and advanced modeling. Every project is infused with scientific rigor, leading to numerous peer-reviewed publications and impactful partnerships. We consistently deliver evidence success stories, helping our partners accelerate drug development with confidence.
Arun Sanyal, Mbbs MD
Professor, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, School of Medicine Internal Medicine, Virginia Commonwealth University
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