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Track 2: Clinical Trials and Clinical Operations
This track covers clinical research development and operations. Sessions explore current and innovative methods to:
- Evaluate technology advances/systems to support clinical research programs and integrate cross-functional management
- Optimize clinical trial enrollment and novel techniques for subject retention
- Evaluate the clinical utility and endpoint development with the use of mobile/digital technology
- Identify clinical questions and gaps resulting in barriers to efficient clinical research development/management
- Review optimal clinical operations management structures in small, medium, and large companies
- Apply innovative protocol techniques, designs, and technology to accelerate decision-making/development
- Review technological advances in clinical research operations including site management, patient enrollment, and project management tools
- Review advances in patient centricity in relation to protocol optimization (quality-by-design), the use of technology and PRO
- Review currently accepted endpoints in selected therapeutic areas and validation considerations for potential future endpoints
- Program challenges and solutions in global clinical and multi-regional clinical trials
- Program management advances in Sponsor/CRO collaborations and vendor oversight
- Discuss the evolving value of real-world data including study designs, operational considerations
Sessions in Clinical Trials and Clinical Operations
Sunday, June 23 | Short Courses
Monday, June 24
- Emerging Technologies in Clinical Research
- Innovation in Enrollment, Recruitment, and Retention
- When Disaster Strikes: Developing a Proactive Plan to Address Challenges Brought on by Large Scale Natural Disasters
- Emerging Technology to Improve Sponsor-Site Interactions
- Blockchain in Clinical Trials Demo: Truth or Dare
- Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans
- Clinical Research in Emerging Regions
- A Large Academic Medical Center’s Perspective on Using Precision Medicine to Find Patient Disease Subgroups at Scale
- Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Tuesday, June 25
- eConsent Done Right
- Protocol Developments of the Future
- Driving Enrollment with a Patient-Centric Focus to Artificial Intelligence
- Assessing Opportunities to Improve Outsourcing Oversight and the Vendor Qualification Assessment Process
- Outcomes, Endpoints, and Methods Supporting Oncology and Alzheimer Therapies
- Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring
- Wearables and Patient Technologies Utilized in Clinical Trials
- Clinical Trial Diversity: Moving from Admiring the Problem to Solving It
- Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You
- Let's Talk Risk-Based Monitoring
- Virtual Clinical Trials
- Using Mobile Sensors in Clinical Trials and Evidentiary Considerations for Electronic Submissions
Wednesday, June 26
- Disruptive Technology Transforming Clinical Trials: The Case for Artificial Intelligence, Blockchain, and Mobile Tech/Wearables
- Operationalizing Master Protocols
- Demystifying Technology Selection in Mobile Clinical Trials
- Risk-Based Monitoring: Best Practice Today and Technology for Tomorrow
- Global Clinical Trials: Make Them Really Global and Involve Africa
- The Analytics Revolution: Opportunities and Threats for Disrupting Clinical Development Operations
- A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock
- Accelerating Drug Development via Structured Content Reuse: Introducing the TransCelerate Clinical Template eSuite
- Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles
- Training for the Electronic Capture of PRO Data in Clinical Trials: Views from ePRO Vendors, Sponsors, Sites, and Patients
- Incorporating Patient Input into the Design and Conduct of Clinical Trials
- Investigational Medicinal Products: eLabeling Initiative, Supply Forecasting Strategies, and Patient-Centric Technology for Medicine Adherence
- A New Path Forward for Using Real World Evidence in Randomized Clinical Trials
- eSource and the Sites: Have They Bonded?
Thursday, June 27
Take a sneak peak into one of our video interviews from DIA 2018 with Dr. Robert Nelson, Senior Director, Pediatric Product Development, Johnson & Johnson, and previously served as Deputy Director and Senior Pediatric Ethicist in the FDA Office of Pediatric Therapeutics. He discusses the regulatory and ethical considerations with placebo administration using a central venous access device in a pediatric trial.
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.