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Track 2: Clinical Trials and Clinical Operations
This comprehensive track covers the latest advances in clinical research and operations. Sessions cover the latest innovations in collecting clinical data, establishing efficiencies in operations, and effective integration of patient outcomes in clinical trial design.
Sessions in Clinical Trials and Clinical Operations
Monday, June 21-Friday, June 25 | Short Courses
Monday, June 28
- Planning for Diversity: A Focus on Site Feasibility and Recruitment Strategies
- Interactive Response Technology Supply Management and Forecasting for Decentralized Trials: Tips on Adapting to Changing Needs
- Measuring Clinically Meaningful Change of Function: A Case Study of Patient-Supported Clinical Outcome Assessments in Early Parkinson
- Value-Based Evidence Generation: What Are the Regulatory and HTA Strategies that Companies Could Take in Development?
- FDA Science Strategies: Purposeful Scientific Leadership to Advance Innovation and Improve Patient Outcomes
- Walking the Talk: What Happens When Clinical Trialists Join Clinical Trials?
- Right the First Time: Integrating Diagnostic Strategies into Clinical Development Plans
- Launching Megatrials During a Pandemic: Lessons Learned from COVID-19 Vaccine Clinical Trials
- Realizing the Value of Digital Biomarkers Across the Product Lifecycle
Tuesday, June 29
- Trial Designs to Minimize Bias and Non-Specific Effects
- Managing Global Trials in Latin America: COVID Impact Update
- Post COVID: Sites Evolving Role in the Clinical Trial Ecosystem
- Quality by Design for Clinical Trials: A Hands-On, Multi-Stakeholder Workshop
- Impact of COVID-19 on Clinical Trial Execution
- Are External Control Arms Ready for Primetime?
- Innovative and Efficient Trial Designs and Statistical Approaches in Small Patient Populations: Rare Diseases and Pediatrics
- Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?
Wednesday, June 30
- Leveraging Smartphones as Measurement Devices for Remotely Conducted Performance Outcome Tests: Notes from the Field
- Real Talk About Artificial Intelligence and Automation in Clinical Research Today
- A Collaborative Cross-Company Pediatric Platform Trial in Pediatric Crohn’s Disease Using an Innovative Bayesian Analysis
- AI-Driven Patient Retention and Engagement for Clinical Trials
- Improving the Ways We Communicate with Patients and Research Participants
- The Rare Disease Clinical Outcome Assessment Consortium: Collaboration Aimed at Accelerating Rare Disease Drug Development
Thursday, July 1
- Considerations for Innovative Trial Design in CNS
- Using Real-World Data in Single-Arm Trials: When it’s Done, Why it’s Done, How it’s Done
- Reliability of Data Results in Clinical Trials (ICH E6 (R2)): What Does it Mean and How Can it Be Accomplished?
- Optimizing Cell and Gene Therapy Clinical Trial Virtualization and Remote Monitoring in the Time of COVID-19
- Remote Implementation of Clinical Outcome Assessments During the COVID-19 Pandemic and Beyond
- Identifying Novel Clinical Endpoints from Continuously Monitored Physical Behavior Using a Wearable Acceleration Sensor
- Assessments to Ensure Data Capture from Representative Populations
Who is This Track Designed For?
DIA recommends this track and associated sessions to professionals involved in: clinical operations, clinical research, safety and pharmacovigilance, project management, patient centricity, and statistics. Also, potentially: medical affairs, regulatory affairs, vendor management/alliance management, data management, and quality assurance.