Client Background
Our CRO client empowers life science research with RWD solutions
Our client is a leading CRO based in the US, with customers across the EU & US. The CRO supports life science companies in conducting real-world studies that require hard-to-access data such as free text notes, imaging data etc. The company offers data subscription services and data collaboration options on demand to pharmaceutical clients to support their research needs effectively. The client intends to promote value-based utilization of advanced real-world data (RWD) sources to support life science companies in informed decision-making.
Challenge
Difficulty in Identifying Long COVID Complications
A leading pharmaceutical company has a pipeline product to treat neurological conditions and is interested to evaluate its indication for treating neurological conditions for Long COVID. Given the complex and evolving nature, understanding COVID-19’s impact on neurodegenerative conditions poses a significant challenge. The pharmaceutical company has requested our client to conduct research for Long COVID outcomes using RWD. The aim was to understand the impact of COVID-19 infection on neurodegenerative conditions which will help them identify potential biomarkers that could predict the onset of neurodegenerative conditions associated with Long COVID.
Healthark’s role
Analyzed Incidence of Long COVID Conditions
Healthark assisted the client in analyzing the retrospective Real-World Data (RWD) using an open-source dataset to assess the incidence of Long COVID-related neurological conditions among patients who tested positive for COVID-19.
- Literature Review and Preliminary Research We conducted a detailed literature review to gather and synthesize existing research on Long COVID and its neurological effects. This review provided a foundation for understanding Long COVID-related neurological conditions and guided the formulation of study parameters and methodologies.
- Cohort Formulation We developed the case and control cohorts for the study, satisfying inclusion/exclusion criteria. The case cohort consisted of COVID-19 positive patients, while the control cohort included influenza-positive patients.
- Analysis Execution We analyzed the incidence of 9 core Long COVID features within 6 months of COVID-19 diagnosis (breathing difficulties/breathlessness, fatigue/malaise, chest/throat pain, headache, abdominal symptoms, myalgia, other pain, cognitive symptoms, and anxiety/depression). The comparison with a propensity score-matched cohort of influenza patients was executed to provide a baseline for understanding whether the neurological impacts observed were specific to COVID-19 or common to other respiratory infections more generally. Kaplan-Meier analysis and the Cox proportional hazard model were used for this comparison. Additionally, Healthark developed models using Logistic Regression and SuperLearner techniques that identify predictors and characteristics that can forecast the likelihood of developing long-term symptoms after a COVID-19 infection. These models will help the client in pinpointing potential biomarkers for Long COVID.
Empowering Tomorrow's Healthcare
This case study demonstrates how our Real-World Data (RWD) analysis uncovered insights into the relationship between COVID-19 and neurodegenerative conditions. Our work helped identify potential biomarkers and laid the groundwork for future research and therapeutic strategies.
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