The Disconnect Between Clinical Trials and Real-World Clinical Settings

Pearson Assessments, the assessment division of global education and assessment company Pearson PLC (NYSE: PSO), is addressing the gap between clinical trial design and real-world clinical practice in the development of Alzheimer's disease treatments. This is driven by the rapidly changing market, with amyloid-beta targeting disease-modifying therapies (DMTs) such as Leqembi (lecanemab) from Eisai and Biogen, and Kisunla (donanemab) from Eli Lilly, recently receiving full approval from the U.S. Food and Drug Administration (FDA). To replicate the efficacy demonstrated in controlled clinical trial settings in real-world clinical settings, the introduction of sophisticated clinical outcome assessments (COAs) is considered essential.

Practical Limitations of Phase 3 Clinical Trials for New Alzheimer's Drugs

Leqembi and Kisunla utilized the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), the Clinical Dementia Rating-Sum of Boxes (CDR-SB), and the Integrated Alzheimer's Disease Rating Scale (iADRS) as key evaluation indicators in their Phase 3 trials. Leqembi demonstrated a 27% delay in cognitive decline at 18 months, while Kisunla showed a 35.1% delay. However, in actual medical practice, there are significant time and infrastructure constraints in performing these precise cognitive assessment tools each time. This necessitates a comprehensive design framework that can flexibly incorporate real-world clinical variables from the clinical trial design stage.

Pearson's Standardized Cognitive Assessment Solution

To address these inconsistencies, Pearson Assessments is providing researchers and clinicians with standardized cognitive and functional assessment solutions. The core of this approach is to establish a patient-centered research paradigm, creating an assessment system that can encompass a diverse range of patients in real-world settings, rather than relying on stringent clinical conditions. This can significantly help pharmaceutical companies demonstrate the commercial value and real-world effectiveness of their drugs after approval. In fact, the availability of a standardized tool for accurately and quickly measuring the level of cognitive decline is the basis for increasing prescription confidence.

Long-Term Strategy for Demonstrating Commercial Viability and Reducing Risk

This advancement in assessment methodology will make a decisive contribution to reducing the commercial uncertainty, which is the biggest hurdle in the Alzheimer's drug market. The global Alzheimer's drug market is projected to reach approximately $15 billion to $22 billion (USD) by 2030, and the DMT segment alone is expected to be a high-growth area, reaching $13.1 billion (USD). Sophisticated clinical design and prescription criteria can shorten the process of securing reimbursement coverage and lower the barriers to prescription by medical professionals, significantly reducing the commercial risk for pharmaceutical companies. Ultimately, standardized technology for acquiring real-world clinical data is expected to become a key indicator that differentiates future biopharmaceutical companies.