Attendees of this session will learn the key regulatory and legal considerations relative to clinical data produced in DCTs. This session describes the following topics:

• Importance of unified terminology for DCTs and current update by the industry
• Regulations and laws impacting DCTs across multiple jurisdictions and countries
• ICH6 –GCP update and revision
• Regulatory GXP rules
• Privacy principles and confidentiality matters
• Data security, ownership, protection, portability, and interoperability
• Case study and lessons learned from DCTs

Moderator & speaker:

Dr Isaac Rodriguez-Chavez
Senior Vice President, Scientific and Clinical Affairs
Head, Strategy Center for DCTs and Digital Medicine
ICON plc

Speakers:

Dawn Chitty
Executive Director
Head of Regulatory Strategy and Agency Liaison/Global Regulatory Affairs
ICON plc

Jo Hulbert
Executive Director
Change Practitioner/Productivity Ninja Ambassador
ICON plc

• Understanding the need to advance R&D digital transformation and reduce legacy approaches and technology that contribute to the rising costs of R&D
• Establishing a technology strategy for a new digital clinical vision that can transform clinical development
• Visualizing the next generation digital trial ecosystem
• Leveraging an integrated digital platform and ecosystem

Speaker:

Amy Apostoleris
Global Head, Digital Clinical Trials Solutions
Medocity

Raj Agarwal
CEO and Co-Founder
Medocity

Stacy Hurt
Patient Engagement Consultant
Digital Health Strategist

In this session, Science 37’s Gordon Cummins and Sanofi’s Paul Rowe, MD will look at how agile clinical trials (comprising at least one decentralized tool or approach, such as a Metasite) offer faster enrollment, greater retention, increased diversity, and improved patient engagement—which, in turn, enable these agile studies to unleash the true potential of real-world data sets.

The presenters will use case studies and data to share best practices for collecting and managing real-world data, along with the most effective applications for using it — and demonstrate why agile clinical trial approaches can be so effective in RWE.

Content will include:

• Why the agile clinical trial is a game-changer for obtaining and using clinical and real-world data
• How the agile model impacts the patient experience, enabling quicker enrollment, better retention and increased diversity
• Best practices for using agile approaches to collect real-world data
• Most effective applications for real-world data
• Creating effective long-term, follow-up studies
• Considerations for calculating the ROI of agile clinical trials and real-world applications

Speakers:

Gordon Cummins
Vice President, Midwest/Southeast / Vice President, Global Real World Evidence  
Science37

Paul Rowe, MD
Vice President, Head of Global Medical, Immunology  
Sanofi

• Define the current state of adoption
• Explore what should now be the "new normal" vs "continued innovation" in the field
• Consider potential futures and what lies ahead for DCT Version 1.1 and DCT 2.0

Speaker:

Craig Lipset
Founder & Advisor
Clinical Innovation Partners
Co-Chair
Decentralized Trials & Research Alliance (DTRA)

In a world where Decentralized Clinical Trials (DCT) are becoming more digital, how can we as an industry continue to deliver exceptional patient care and make participating in trials easier, all while making best use of clinical and digital technology (eClinical)solutions?

eClinical expert, Edward Triebell, will share his knowledge and experience on the importance of robust digital elements as part of your decentralized clinical trial strategy and how digital solutions have impacted and will continue to impact the clinical trials industry.

During this keynote meeting, MRN will share learnings and best practices on working with digital tools as part of your DCT molecule and show you how combining healthcare professionals with digital tools can empower and deliver the most benefits for your trial.

Speaker:

Edward Triebell
Executive Director – Digital Health Research & Development
MRN

• Gain insight into trends and metrics to position you for success.
• Review the data on technology and decentralization as it impacts the research site.
• Use the information shared during this solution-focused discussion to make an impactful change at your organization.

Speaker:

Jimmy Bechtel
Site Engagement Vice President
Society for Clinical Research Sites

Unlocking the potential of the next generation of clinical trials will require transformative change in how we approach collecting and managing clinical data. As we move beyond CRFs and embrace eSource, committing to collecting structured data will be vital. With structured data, data ontologies can both increase the usefulness of the data collected, and reveal previously-hidden insights, but only if we are willing to make the investment.

Speaker:

Derk Arts
CEO
Castor

Gain understanding and insight on technology selection when incorporating remote patient monitoring into study outcome assessments; Differentiate between wearables, physiologic parameters, and derived parameters, as well as considerations in implementation.

Speaker:

Mariel Fabro
Head of Product
Vivalink

• Definition of DCT
• Information on national project on DCT
• General considerations on DCT

Speaker:

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

Define a validated, holistic approach by Medable to mitigate the challenges of vaccine studies. A multi-modal, platform-enabled DCT pathway designed specifically for vaccine studies.

Speaker:

Musaddiq Khan
Vice President, DCT Solutions
Medable

Over the past year, it is estimated that one quarter of all clinical studies have included a decentralize component or components[1]. We have seen the way we collect clinical research data significantly change due to COVID related travel restrictions. We have seen the increase of data collection from virtual/telehealth visits, home health providers in a patient’s home, and wearable medical devices. Our tools for measuring performance and success within these types of studies need to change to stay relevant to this new paradigm.

Traditional data management metrics, as referenced in the GCDMP are broken down into paper-based metrics and EDC based metrics. Currently there isn’t any mention of metrics in decentralized trials. Metrics such as ‘the number of days from Patient Visit complete to eCRF page entered in EDC system’[2] may not be relevant with direct data capture technologies. Some items such as ‘Calendar days from time query generated to query response on EDC system’[3] are no longer measured in days or weeks, but oftentimes can be measured in hours.

This presentation will provide thought leadership on a new analytics methodology to measure the compliance, timeliness and quality in a decentralized trials environment.

[1] Chancellor, Daniel. (2020, July 21). Decentralized and Hybrid Trials 2020 [Presentation]. PharmaIntelligence and Clinical Trials Europe. https://pharmaintelligence.informa.com/resources/product-content/2020/07/20/10/43/sitecore/shell/~/media/informa-shop-window/pharma/2020/covid-24-campaign/slides/decentralized-clinical-trials-in-2020.pdf

[2]&3 SCDM GCDMP 2013 Metrics in Clinical Data Management

Speaker:

Jennifer Price
Executive Director, Data & Analytics
THREAD Research

• Share the decentralized operational model for the trial
• Share how the decentralized model has been adapted to accommodate local practices in countries
• Share HA feedback
• Learnings to date

Speakers:

Elizabeth Theogaraj
Global Regulatory Lead
Roche

Bettyna Brivet-Jones
Operations Program Leader
Roche