New Approaches to Improving Endpoint Selection for Clinical Trials
Endpoint selection is a critical aspect of clinical trial design, as it directly impacts the ability to showcase treatment efficacy to regulatory authorities, payers, clinicians and the ultimate stakeholder: patients. Folia Health’s Outcome Inventory provides life sciences sponsors with a patient-focused solution for comprehensive outcomes discovery research. In this blog post, we will delve into Folia Health's innovative methods and technologies that enhance the discovery of measurable disease burden concepts, leading to more effective endpoint selection and meaningful clinical trial outcomes.
Folia Health's Outcome Inventory: A Patient-Focused Approach
Folia Health's Outcome Inventory takes a truly patient-focused approach to outcomes discovery research. Upon consenting and onboarding into the study, participants select from a dynamic and user-friendly list of potential outcomes-of-interest to track their own disease burden. They also have the flexibility to self-select additional outcomes-of-interest that may not be on the suggested list. Folia Health's solution also incorporates validated ePRO scales as comparators, ensuring reliable and validated data. By engaging participants and capturing their perspectives, Folia Health enables a comprehensive and nuanced understanding of disease burden, uncovering a wide range of symptoms and outcomes that may go beyond traditional measures.
Efficient Data Capture and Comprehensive Discovery:
Folia Health's proprietary end-to-end solution streamlines data capture while minimizing patient responder burden. Through our highly configurable patient-centered technology, we ensure efficient enrollment, consent, onboarding, and data collection. The structured data format eliminates the need for transcription or “notes” data curation, allowing for easier and faster analysis. Folia Health's methods lead to the most comprehensive discovery of measurable disease concepts, including symptom severity, baseline HRQoL, flare events, and current treatments. Researchers can analyze these participant-selected outcomes (we call them Home Reported Outcomes - HROs for short) to gain a deep understanding of the target population's lived experiences, informing endpoint selection and trial design.
Case Study Highlights: Uncovering Multifaceted Disease Concepts:
In a case study, Folia Health's methods revealed three times the number of unique symptoms compared to traditional concept solicitation approaches. The concept of pain, for example, was found to be more multifaceted than previously recognized, with participants reporting various types of pain and variations in severity and frequency. Folia Health's methods allowed for the generation of severity scores for all identified symptoms, providing a more nuanced understanding of disease burden. Amongst the many applications of these findings, ensuring the right endpoints are selected for a pivotal trial in the condition stands out as a critical one.