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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 24 | Short Courses
Monday, June 25
- The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials
- From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design
- The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials
- eSource: The Road to Real World Evidence – Are We There Yet?
- Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes
Tuesday, June 26
- Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality
- Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials
- Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible
- Global Clinical Trials: Lessons in Effective Execution
- Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments
- Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA with an Eye Towards Mobile Technology Collection
- Digitizing a Patient-Focused Clinical Trial Experience
- Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go
- Redefining the Site Investigator's Experience
- Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers
- Future of Endpoints
Future of PharmaTech
Wednesday, June 27
- Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial
- Data and Quality Approaches to Informing Global Investigative Site Selection
- Artificial Intelligence: Robots Taking Over Clinical Research
- Rebuilding or Building a Research Site in the Year 2020
- A New Way of Authoring and Reviewing Documents for Clinical Development
- Implementation of eConsent and Other Digital Clinical Trial Innovations
- Innovations in Managing Global Clinical Supplies
- Does Sourcing Strategy Matter? Executives Debate the Influence of Outsourcing Model on Clinical Trial Execution
- Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?
Thursday, June 28
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.