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Data Science Solution to Event Prediction in Outsourced Clinical Trial Models.
Daniel Dalevi1, Susan Lovick2, Helen Mann2
1Advanced Analytics Centre, Biometrics and Information Sciences, AstraZeneca, Sweden/UK.
This study introduces a standardized event prediction tool for clinical trials, enhancing trust and communication between sponsors and Contract Research Organizations (CROs). The dynamic web application improves reliability and transparency in statistical analysis.
Area of Science:
- Clinical research
- Statistical modeling
- Data science in healthcare
Background:
- Late-phase clinical trials are frequently outsourced to Contract Research Organizations (CROs), with sponsors retaining ultimate risk and accountability.
- Statistical tasks performed by CROs often require revalidation by in-house sponsor teams, creating potential inefficiencies and trust gaps.
Purpose of the Study:
- To present a technological approach for standardized event prediction in clinical trials.
- To introduce a dynamic web application built around an R-package designed to foster transparency and trust between CROs and in-house statisticians.
- To demonstrate the benefits of standardization in improving communication and reliability for time-to-event prediction, particularly in oncology.
Main Methods:
- Development of a dynamic web application integrated with an R-package for standardized event prediction.
- Focus on key features including a short learning curve, interactivity, reproducibility, and data diagnostics.
- Application motivated by time-to-event prediction in oncology clinical trials.
Main Results:
- The developed tool offers reliable event predictions, simplifying communication and increasing trust through transparency.
- Demonstrated clear benefits of standardization for both CROs and sponsor companies.
- The application supports exploration, communication, sensitivity analysis, and standard report generation.
Conclusions:
- Standardized event prediction tools can significantly enhance collaboration and efficiency in outsourced clinical trial statistics.
- The presented web application provides a transparent and reproducible method for time-to-event predictions, particularly beneficial in oncology.
- Adoption of such tools can lead to improved data integrity and streamlined workflows between research organizations.