08:45 - 16:40 EST | 14:45 - 22:40 CEST

* Please note that the following agenda timings are Eastern Standard Time.  

For Central European Summer Times, please download the full event guide here

Starting with Solid Foundations: Pragmatic Guidance for Innovating, Operationalizing & Optimizing DCTs

8:45 am Chair’s Opening Remarks

Investigating the KPIs & Lessons Learnt for Setting Up, Innovating & Operationalizing DCTs

9:00 am Execution of a Randomized Decentralized Clinical Trial – a J&J Case Study

Synopsis

• Describing the pioneering exploration into a decentralized trial format with randomization
• Expanding upon enrolment, communication, drug delivery, recruitment challenges and lessons learned
• Describing the patient journey and providing a toolkit of future stakeholder considerations

9:25 am DiMe on DCTs: Your How-To Guide

  • Rachel Chasse Director of Innovation, Digital Medicine Society (DiMe)

Synopsis

Learn actionable guidance from the Digital Medicine Society (DiMe) on best practices for developing your DCT, including:
• The value of remote patient monitoring
• Selecting the right digital endpoints for a trial
• Methods for evaluating digital clinical measures for use

9:50 am Innovation & High Impact on Patients’ Health Journey: Integrating Decentralized Clinical Trials (DCTs) with Clinical Research as a Care Option (CRAACO)

Synopsis

• Discussing synergies between DCTs and CRAACO
• Recounting the symbiotic architecture of combining the clinical research and health care system into one enterprise
• Highlighting the advantages of patients’ health tracking and continual monitoring following the DCT-CRAACO integration model

10:25 am Morning Q&A and Panel Forum

10:40 am Networking Break

10:50 am Speed Networking

Synopsis

Network with other attendees in our quick-fire networking session. Grab a hot drink and let the computer match you randomly with a range of attendees in 1-1 formats. Make sure to click “connect” to swap virtual business cards

11:20 am Panel: What Does a Good Decentralized Clinical Trials Look Like?

Synopsis

• Understanding the initial DCT goals
• Recounting how to predict and qualify patient number and compliance
• Providing fixed initial performance metrics that allow continued comparison

12:10 pm Evaluating Clinical Trials for a Decentralized Approach

  • Amy Bohn Director, DCT Operations DCT Strategy & Implementation, Bayer

Synopsis

• Detailing the experience and approach for evaluating DCT prospects
• Determining important considerations when selecting the DCT components to apply
• Engaging stakeholders during evaluation

12:35 pm Syneos Health Talk Reservation

1:00 pm Midday Q&A panel

  • Amy Bohn Director, DCT Operations DCT Strategy & Implementation, Bayer

1:10 pm Virtual Networking Lunch

Optimizing Regulatory Considerations & Patient Needs for DCT Success & Compliance

2:10 pm Removing Complexity: The Art of Cutting Tethers to the Trial Site

  • Steven R. Cummings Executive Director, San Francisco Coordinating Center, California Pacific Medical Center Research Institute

Synopsis

• Recalling research into the biggest factors hindering a DCT success
• Recounting experience in the TOPaZ trial and DCT implementation
• Encouraging the goal or looking forward rather than backward

2:35 pm PCM Trials Reserved Space

2:50 pm Using Systems Modelling to Compare & Contrast Centralized vs Decentralized Clinical Trials

Synopsis

• Utilizing systems thinking for pragmatically assessing comparative differences of a DCT as compared to a CT
• Practically using dynamic modeling and simulation methods to create wider insights into the performance of a DCT versus CT

3:05 pm Afternoon Q&A Panel Forum

  • Jim Hacunda R&D Digital Strategy Lead, Takeda
  • Steven R. Cummings Executive Director, San Francisco Coordinating Center, California Pacific Medical Center Research Institute

3:25 pm Case Studies from Running Patient Centric Clinical Trials Supported by Remote & Virtual Elements

  • Gunilla Andrew-Nielsen Head of Department of Clinical Trials and Special Permissions, Medical Products Agency

Synopsis

• Exploring the regulatory challenges with the running of remote trials in a global trial landscape
• Detailing methods to communicate with a range of stakeholders and provide innovative advice
• Highlighting the Swedish Medical Product Agency Model and comparing with the wider EU framework

3:50 pm Some ‘Savvy’ Solutions to Providing Your Patients with Choice in a Decentralized Clinical Trial

Synopsis

• Identify barriers or perceptions of underrepresented patient populations, and why you need to address them if you want a representative sample for your trial
• Learn to identify when and how you can engage patients as you plan and design your remote clinical trial
• Uncover best practices for getting patient input and the implications that has on your trial’s recruitment and retention success

4:15 pm Best Strategies to Optimize Patient Enrolment & Health Care Provider Engagement in the Digital Era: A Case Study

Synopsis

• Discussing the adaption to a telehealth model and changes in digital care responsibilities
• Sharing best practice on training HCPs and others on the technology requirements
• Displacing some commonly cited issues in the DCT framework and elaborating on key challenges

4:40 pm Designing a Hybrid Trial to Support Patient Choice

  • Tracey Robertson Global Clinical Development & Operations – Head of Patient & Site Engagement Process , Boehringer Ingelheim

Synopsis

• Defining what hybrid looks like through an industry lens
• How to apply decentralized components to best meet patient solutions and requirements

5:05 pm Closing Q&A & Panel Forum

  • Gunilla Andrew-Nielsen Head of Department of Clinical Trials and Special Permissions, Medical Products Agency
  • Arturo Loaiza-Bonilla Enterprise Director of Research, Cancer Treatment Centers of America
  • Jen Horonjeff Founder & CEO, Savvy Cooperative
  • Tracey Robertson Global Clinical Development & Operations – Head of Patient & Site Engagement Process , Boehringer Ingelheim

5:25 pm Chair’s Closing Remarks

  • Steven R. Cummings Executive Director, San Francisco Coordinating Center, California Pacific Medical Center Research Institute