Case Study: Enhancing Data Collection in a Phase III Oncology Study

Client: Leading Pharma Company

Study Phase: Phase III Oncology Study

Challenges:

Efficiently collecting patient-reported outcomes (ePRO) from a severely ill population.
Ensuring high patient compliance rates.
Managing and analyzing large volumes of diverse patient data.

Solutions Used:

Clinical StudyPal ePRO
eConsent
Delve Concierge Services

Background

A leading pharma company conducting a Phase III oncology study faced significant challenges in collecting patient-reported outcomes (ePRO) from patients with severe health conditions. The study aimed to gather comprehensive and accurate data while ensuring high compliance rates and effective data management.

Objectives

Enable efficient collection of ePRO data from patients.
Improve patient compliance through dedicated support services.
Enhance data quality and completeness despite the tough, sick population.

Solution Implementation

1. Clinical StudyPal ePRO and eConsent: Delve Health’s platform was deployed to streamline the collection of ePRO data and manage the consent process. The Clinical StudyPal app was provided to patients, allowing them to easily report their health status and symptoms from their homes.

eConsent: Patients were remotely consented using the platform’s eConsent solution, simplifying the consent process and ensuring that patients were well-informed about the study requirements.
ePRO Data Collection: The Clinical StudyPal app enabled patients to log their health data regularly, designed to be user-friendly even for patients with severe health conditions.

2. Delve Concierge Services: The Delve Health Concierge team played a crucial role in improving patient compliance and engagement. The team provided personalized support to patients, helping them navigate the app and adhere to their reporting schedules.

Personalized Support: Patients received one-on-one assistance from the Concierge team, addressing any technical issues and providing reminders for data entry.
Regular Check-ins: The Concierge team conducted regular check-ins with patients to ensure they were comfortable using the app and to encourage consistent data reporting.

Results

1. Increased ePRO Data Collection Efficiency: The implementation of the Clinical StudyPal ePRO solution significantly improved the efficiency of data collection. Patients found the app easy to use, which facilitated regular and accurate reporting of their health status.

User-Friendly Interface: The app’s intuitive design made it accessible for patients, leading to higher engagement and more consistent data entries.
Reduced Burden on Patients: By enabling remote data reporting, patients were spared the physical strain of frequent clinic visits, which was particularly beneficial given their severe health conditions.

2. Improved Compliance Rates: The Delve Concierge Services were instrumental in maintaining high compliance rates among patients.

High Compliance: Personalized support and regular check-ins ensured that patients adhered to their reporting schedules, resulting in compliance rates of over 90%.
Enhanced Patient Engagement: The supportive and empathetic approach of the Concierge team helped keep patients motivated and engaged throughout the study.

3. Enhanced Data Quality and Completeness: The combination of the ePRO solution and Concierge Services led to a significant improvement in the quality and completeness of the data collected.

Comprehensive Data: Regular and accurate patient reports provided a wealth of data for analysis.
Timely Insights: The real-time data collection enabled timely insights into patient health trends, aiding in better decision-making for the study.

Conclusion

The Delve Health platform, combined with dedicated support from the Delve Concierge team, enabled the successful collection of ePRO data in a Phase III oncology study. The system’s user-friendly design and personalized patient support resulted in high compliance rates and enhanced data quality, even in a tough, sick population. This comprehensive approach significantly contributed to the success of the study, providing valuable insights and improving overall data collection efficiency.

Key Takeaways:

Efficient ePRO data collection through a user-friendly app.
High patient compliance achieved with personalized support.
Enhanced data quality and completeness, enabling better study outcomes.

Client Testimonial: “Delve Health’s platform and Concierge Services transformed our Phase III oncology study. The ease of data collection and the exceptional support provided to our patients were pivotal in achieving high compliance rates and ensuring the success of our study.”