strategies for managing and utilizing PGHD in CT (1).pptx
- 1. Welcome Strategies for managing and utilizing PGHD in clinical trials Student’s Name : G.prathyusha Student’s Qualification: Pharm.D Student ID Here: 181/072024 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1
- 2. Index • Introduction to PGHD • Benefits of PGHD in clinical trials • Challenges of managing PGHD • Strategies • Conclusion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2
- 3. Introduction to PGHD 3 www.clinosol.com | follow us on social media @clinosolresearch Definition: Data collected directly from patients outside clinical settings, such as from wearables, mobile apps, and patient surveys. •Examples of PGHD: Heart rate, activity levels, medication adherence, symptom tracking, and patient-reported outcomes. •Value of PGHD: Enables real-time, real-world insights; supports personalized treatment; enhances patient engagement. •Patient-Generated Health Data (PGHD) can add rich insights to clinical trials, supporting patient-centered care and enabling real-world evidence collection. However, effectively managing and utilizing this data requires careful planning and strategy. Here are some strategies:
- 4. Benefits of PGHD in Clinical Trials •Rich Data for Real-World Evidence: Captures patient behaviors, adherence, and symptoms in real-world settings. •Patient-Centric Insights: Empowers patients to contribute directly to their care. •Improved Monitoring and Adaptation: Supports continuous monitoring, allowing for adaptive trial designs and personalized interventions. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4
- 5. Challenges of managing PGHD 5 www.clinosol.com | follow us on social media @clinosolresearch Data Volume and Quality: Managing large volumes of data, ensuring accuracy and relevance. •Privacy and Compliance: Complying with GDPR, HIPAA, and other regulations while safeguarding patient privacy. •Technical Integration: Integrating diverse data sources into trial data management systems. •Patient Engagement: Keeping patients motivated to consistently provide data.
- 6. Strategies 1. Define Objectives and Data Types • Objective Clarity: Clearly define what you aim to achieve by integrating PGHD into the trial. Objectives might include tracking symptoms, monitoring adherence, understanding patient behaviors, or collecting real-time feedback. • Data Type Selection: Decide on the types of PGHD you need, such as wearable device data (e.g., heart rate, steps), patient- reported outcomes (PROs), or environmental/contextual data (e.g., activity level, location). 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6
- 7. 2. Establish Data Governance and Compliance • Regulatory Compliance: Ensure PGHD handling complies with GDPR, HIPAA, and other applicable regulations. This includes proper consent, data anonymization, and ensuring that data collected remotely has the same level of compliance as on-site data. • Data Ownership and Access: Define data ownership and control policies, and clarify how patients can access their data or withdraw it if needed. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7
- 8. 3. Implement Robust Data Collection and Integration Systems • Platform Selection: Choose or develop a platform that can seamlessly integrate PGHD from different sources (e.g., apps, devices) into the clinical trial data management system. • Data Standardization: Use interoperable standards (e.g., HL7 FHIR) to ensure consistency and facilitate integration with electronic health records (EHR) and other data management platforms. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8
- 9. 4. Ensure Data Quality and Relevance • Validation and Calibration: Use validated tools, sensors, and methods for PGHD collection. Quality checks should be implemented to filter out anomalies and ensure accurate, reliable data. • Regular Data Audits: Establish protocols to regularly review the data to confirm its integrity and relevance. This may include setting thresholds for data quality or having automated checks for anomalies. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9
- 10. 5. Engage Patients and Provide Training • Patient Education and Support: Educate patients on the importance of accurate data capture, and provide clear instructions and support on using devices or apps. • Continuous Engagement: Regularly engage with patients to encourage adherence, address concerns, and ensure ongoing data collection. Gamification or reminders may also help sustain engagement over time. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10
- 11. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11 6. Utilize Advanced Analytics for Insights • Real-Time Monitoring: Use AI and machine learning to monitor PGHD in real-time, identifying trends or alerting clinicians to early signs of adverse events. • Data Analysis for Personalized Insights: PGHD allows for more personalized insights into patient behavior, treatment response, and adherence. Leverage analytics to create patient-centric insights and adapt interventions based on real-time data.
- 12. 7. Build Feedback Loops for Adaptive Trial Designs • Dynamic Protocol Adjustments: Use PGHD to enable adaptive trial designs, where real-time insights can guide protocol adjustments to improve outcomes, such as modifying treatment dosage or frequency based on patient response. • Patient Feedback Integration: Integrate patient feedback about the PGHD process and trial experience to identify areas for improvement, making the trial more responsive to patient needs. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 12
- 13. 8. Ensure Data Security and Privacy • Data Encryption and Security Measures: Implement strong encryption, secure data storage, and controlled access protocols to protect patient privacy and data integrity. • Transparency with Patients: Be transparent with patients about how their data will be used, stored, and shared, and give them control over their data sharing preferences. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 13
- 14. By following these strategies, clinical trials can maximize the value of PGHD, enhancing data quality, improving patient engagement, and supporting the shift toward more adaptive and personalized trial designs. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 14
- 15. Conclusion • Recap of Key Strategies: Define clear objectives, establish governance, ensure data quality, engage patients, and use analytics. • Future of PGHD in Trials: Emphasizes shift towards more patient-centered and adaptive trial designs. • Final Thoughts: Effective PGHD management is key to unlocking its full potential in clinical research. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 15
- 16. ThankYou! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 16