Identifying Key Factors for Planning a Decentralized Clinical Trial
8:50 am Opening Remarks
9:00 am Panel Discussion: Achieving Buy-in & Adoption from Stakeholders for DCTs
Synopsis
- Discussing strategies to convey the value proposition and benefits of DCTs to stakeholders
- Improving internal and external collaboration to maximize DCT success
- Debating the potential methods to measure the success of DCTs
9:30 am Case Study: Meeting Patients and Health Systems Where They Are
Synopsis
- Incorporating the patient voice to optimize DCT design
- Considerations for a strategic and adaptive protocol design
- Metrics and key performance indicators of success
9:45 am Understanding the Multiple Factors & Trends Influencing DCT Designs & Deployment
Synopsis
- Understanding key factors to consider when designing and deploying DCTs
- Linking factors with quality by evidence in DCTs
- Appraising trends in DCTs and the changing landscape in clinical research
10:15 am Proactively Preparing for Successful Deployment of a DCT
Synopsis
- Factoring operational challenges into the planning stage
- Aligning internal teams for operational success
- Establishing collaborative relationships with external partners
10:45 am
Structured Networking
11:00 am
Morning Break
Creating the Playbook for Navigating Global Regulations
11:15 am Panel Discussion: Identifying Where Different DCT Opportunities are Globally
Synopsis
- Highlighting different technologies that best support DCTs
- Discussing different approaches to identifying effective technologies
- Comparing the FDA’s to different country’s attitudes and approaches towards DCTs
12:00 pm The Scientific Art of Innovative Clinical Trial Design
Synopsis
- Trial Design Application Tool: Using technology to inform trial design possibilities
- Layering experiential knowledge on top of standard processes and capabilities
- Resulting in patient centered Global Innovative Trial Designs
12:30 pm Interactive Group Discussion – Planning & Adapting to New DCT FDA Regulations
Synopsis
This interactive session will give you the opportunity to dive into the conversation with your fellow colleagues to discuss, debate and get inspiration on how to approach:
- Evolving DCT regulations
- Exploring synergies between RWE and DCTs – approaches and use cases
- Managing the collection of data from the RWE and DCTs using digital health technologies
1:00 pm
Lunch Break
Designing Equitable & Patient-First Decentralized Clinical Trials
2:00 pm TECH SPOTLIGHT! LIGHTNING ROUNDS – New for 2022
Synopsis
You can’t run a DCT without technology – and with the technology that enables these trials innovating at lightning speed, its vital that you know what best-in class
looks like! In this rapid-fire tech spotlight, three of the most innovative new DCT enabling tech providers will give you a lightning-speed overview of how they can revolutionize your DCT.
2:30 pm Designing a Clinical Trail Around the Patient
Synopsis
- Reducing the burden on the patient and caregivers
- Reflecting on the lessons learned to factor into future planning
- Dedicating continuous technical support to optimize technology
3:00 pm
Afternoon Break
3:30 pm Considering Optionality and Agility while Planning a DCT
Synopsis
- Addressing the need to select appropriate DCT techniques for specific studies and populations, while maintaining optionality for patients
- Applying various DCT techniques in clinical trials
- Leveraging agility in remote study monitoring and outlining novel techniques
that add the most value
4:00 pm Providing Innovative Solutions for an Enhanced Patient and Provider Experience
Synopsis
- Understanding the benefits of a virtual clinical supply model
- Leveraging medical claims processes for exams, services, and product reimbursement
- Maximize community resources to decentralize study components
4:30 pm Panel Discussion: Examining DCT Patient Engagement Issues
Synopsis
- Discussing ideas to increase patient awareness
- Improving the education of patients
- Analyzing FDA global regulations regarding patient involvement