Client Background
Global CRO Exploring ITT & Advancing RWD Research
Our client is a globally renowned CRO specializing in real world data (RWD) solutions and clinical research. Headquartered in the US, the organization supports pharmaceutical clients in Europe and the US by leveraging cutting edge technologies to analyze datasets. In this study, the client aimed to address protocol deviations and data variability issues in a protein supplement study using Intention to Treat (ITT) analysis to ensure reliable insights. Their expertise spans protocol compliance management, patient behavior tracking, and decision making through RWD to drive informed healthcare outcomes.
Challenge
Difficulty Addressing Variability in Protocol Adherence & Compliance
The study faced challenges due to variability in scheduling the final visit, which aligned with the final follow-up and depended on hospital timelines. This inconsistency resulted in protocol deviations and incomplete data collection near the expected timeframe for the final visit. The wide variation in timing, with the final visit occurring across a broad range relative to the planned date, further diminished the pool of analyzable patients over time, compromising statistical significance. Addressing these issues was crucial to maintain integrity and ensure reliable trial outcomes.
Healthark’s role
Addressing Protocol Deviations with ITT Analysis
Healthark ensured a robust analysis of the supplement’s efficacy by adopting an ITT approach to mitigate the risk of losing valuable patient data. By including all patients in the analysis, regardless of compliance or visit timing, this method preserved the sample size and ensured the results remained statistically meaningful.
- Tailored ITT Analysis Implementation Devised an ITT analysis framework to include all patients, addressing noncompliance and withdrawals while minimizing bias.
- LOCF Method Application Applied the Last Observation Carried Forward method for handling incomplete data points to maintain study continuity.
- Dual Approach Insights Complemented ITT analysis with Per-Protocol (PP) analysis to differentiate real-world performance from controlled efficacy.
- Ensuring Meaningful Outcomes Designed analyses to emphasize statistically significant results despite variability, ensuring reliable conclusions could be drawn from the study.
Empowering Tomorrow's Healthcare
This case study highlights how Healthark’s expertise in managing real world challenges and applying advanced methodologies ensured comprehensive and reliable insights for a leading clinical research organization. By addressing data variability and employing robust methods, we preserved endpoint integrity and delivered actionable outcomes. Our work highlights the impact of innovative analytical approaches in advancing healthcare research and decision-making.
Want to learn more about Healthark’s expertise in RWE analysis and real world data solutions? Explore our website or contact us today!
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