Clinical Trials Operational Successes Post COVID-19: A Virtual Symposium

Register free: http://www.appliedclinicaltrialsonline.com/act_w/post_covid

Event Overview:
In this two-day online event, speakers will discuss strategies, technologies and processes impelemented during COVID-19 that serve as operational successes for clinical trials moving forward. The first day will cover Patient Participation Success and the second The Now/New Clinical Trial Technologies. There will be live Q&As with the speakers as a group after each day’s sessions. Attendance is free.

Day One, Thursday, February 11, 2021: Patient Participation Success

12:00pm EST Welcome and Introductions

Lisa Henderson, Editorial Director, Applied Clinical Trials

12:05pm EST Ensuring Trial Continuity During COVID-19 Using Home Care
Milica Kelley, Manager, Global Clinical Operations Special Projects, Symphony Clinical Research and Amy Burke, Manager, Clinical Operations, Alnylam

An estimated 80% of clinical trials were interrupted or put on hold as a result of COVID-19 in 2020. Amid varying quarantine regulations, Symphony Clinical Research used home nursing services across the globe to help Alnylam administer critical study drug doses to patients and perform other necessary visit activities. This case study review will outline best practices for trial continuity in times of crisis.

12:35pm EST Clinical Trial Participation: Understand the Needs & Importance of Diverse Populations
Joan A. Chambers, Senior Director, Marketing & Outreach, Center for Information & Study on Clinical Research Participation (CISCRP)

This presentation will focus on the Journey of Clinical Trial Participation. Ms. Chambers will share insights and data that focus on patient centricity, technology and enhancing the patient’s experience.

• Understand the importance of patient diversity in clinical trial participation
• Exploring different perceptions about clinical research among diverse demographics
• Ensuring patient safety and compliance through the use of relevant technologies
• Simplifying the process for patients through exploring the potential for patient apps and video dosing
• Considering the concept of continuous data collection with wearables to remotely capture, transmit, and store data in a secure platform
• Exploring the future of patient centricity within clinical trials; how is this process likely to evolve over the next couple of years?

1:05pm EST Lessons Learned from a Community Hospital Building a COVID-19 Research Program
Beth Gleason, Director, Research Administration; Mackenzie Steinbach, Supervisor and Michelle Perkins, Laboratory Supervisor, all with Honor Health

The HonorHealth Research Institute built a COVID-19 research program to provide care and access for the Scottsdale, Arizona community. This presentation will focus on:

1:35pm EST The Power of Patient Registries
Vanessa Boulanger, Director of Research Programs, NORD

This presentation will focus on research lessons learned about COVID from the rare disease community, the power of patient registries in sustaining seamless and virtual participation in research, as well recent collaborations with CBER.

2pm EST Close of Day 1

Day Two, Friday, February 12, 2021: The New/Now Clinical Trial Technologies

8:00am EST Welcome and Introductions

8:05am EST Moving Decentralized Clinical Trials from Edge Case to Main Case
Alison Holland, Head of Decentralized Trials, Medable and Noolie Gregory, Executive Director, Client Engagement Real World Late Phase, Syneos Health

We learned a lot in 2020 as the industry raced to adopt more remote technologies and decentralized trial methodologies. The move to DCTs represents a transformational step across the entire drug development lifecycle, beyond just clinical. To get it right, we need to bring the people (sites, patients, and pharmaceutical partners), processes (real-world data, real-time data, integrations, and study designs), and technology together seamlessly. In this presentation, Medable and Syneos Health reflect on lessons learned and explore how these learnings will shape the future. They will outline how to create fit-for-purpose decentralized clinical trial solutions to meet the needs of multiple stakeholders while enabling greater trial participation to improve diversity in trials. The presenters will explore the full spectrum of DCT approaches (hybrid, remote consent, etc.) and how to apply modern tools to enable choice, improve the patient experience, and enhance study design. Gregory and Holland will end with a deep-dive discussion into what DCT adoption means for patients, sites, CROs and pharmaceutical and biotech companies with real-life use case examples.

8:35am EST The Remote Monitoring Toolkit
Penelope Manasco, MD, CEO of MANA RBM

Remote monitoring is much more than just performing SDV on data remotely. One must consider all aspects of monitoring that can be performed remotely. During the presentation, Dr. Manasco will review the technologies that enhance remote trial management including software managing all aspects of data and document collection. In addition, she will share case histories of successful innovations that enhance remote quality oversight to identify protocol-specific critical errors across all data sources in near real time –including remote blinded investigational product management and accountability, automated SUSAR identification, and oversight of primary endpoints.

9:05am EST Trends in Trial Design and Technology for Pediatric Research
Lindsay Singler, Director, Research Communication & Engagement, Duke Clinical Research Institute and Bernadette Tosti, VP, Patient Experience for Science 37

Current events have driven pediatric clinical research to be more flexible and efficient—to increase patient access and enhance the patient experience both during the COVID-19 pandemic and beyond. With increased regulatory support for direct-to-family (decentralized) trials, learn how to leverage technology to safely and efficiently conduct research using a current, real-life example of trial design.

9:35am EST How Will Use of Technology in Clinical Research Affect Your Job?
Kimberly Ray, Consultant, Working Group Leader, ACRP

In January 2020, ACRP convened a working group of representatives from pharma, CROs, technology companies and sites to discuss this question. In May 2020, ACRP and Continuum Clinical surveyed clinical research staff regarding how their roles had changed due to the COVID-19 pandemic. In this session, we will discuss the insights that we gained from the Working Group as well as the 342 survey responses including:

• What is the primary way traditional staff roles will be affected?
• What new roles will likely be created as more technology is embraced
• What new skills will be needed to be successful in this “new normal”
• How do the recommendations compare between those for sites and those for sponsor/CROs?
• What is the overall piece of advice to sponsors and sites during this time of transformational change?

10:05am EST Close of Day 2.

Speakers: Milica Kelley, Manager, Global Clinical Operations Special Projects, Symphony Clinical Research

Amy Burke, Manager, Clinical Operations, Alnylam

Joan A. Chambers, Senior Director, Marketing & Outreach, Center for Information & Study on Clinical Research Participation (CISCRP)

Beth Gleason, MA, CCRC, Director, Research Operations, HonorHealth Research Institute

Mackenzie Steinbach, MEng, Clinical Research Supervisor- Infectious Disease, GI/Bariatrics, Pulmonology, HonorHealth Research

Michelle Perkins, Laboratory Supervisor, HonorHealth Research

Vanessa Boulanger, Director of Research Programs, NORD

Alison Holland, Head of Decentralized Trials, Medable

Noolie Gregory, Executive Director, Client Engagement Real World Late Phase, Syneos Health

Penelope Manasco, MD, CEO, MANA RBM

Lindsay Singler, MPH, Director, Research Communication & Engagement, Duke Clinical Research Institute

Bernadette Tosti, VP, Patient Experience, Science 37

Kimberly Ray, Consultant and Working Group Leader, ACRP

Time and Date: Day One: Thursday, February 11, 2021at 12pm EST
Day Two: Friday, February 12, 2021 at 8am EST

On demand available after final airing until Feb. 11, 2022

Register free: http://www.appliedclinicaltrialsonline.com/act_w/post_covid