These days, no one is arguing about the continued decentralization of trials (DCT). Instead, many are working on establishing their organization’s scalable DCT strategy for 2021 and beyond.

As an industry leader and pioneer in decentralized trials, Medable has developed a robust readiness framework that we use when assessing protocol-fit readiness for optimised DCT design with our clients. Join Rasmus Hogreffe VP of Decentralized Clinical Trial Innovations, Medable, and Andrew Mackinnon Digital Trial Operations Lead, Medable as they uncover what it takes for organizations to be “ready” for the future of DCT.

Attendees will walk away with an understanding of the key areas of DCT evaluation, the different types of frameworks they can employ, an understanding of their organization’s own readiness, and how best to create a path forward for 2021 and beyond.

Speakers:

Rasmus Hogreffe
VP, Decentralized Clinical Trial Innovation
Medable

Andrew Mackinnon
Digital Trial Operations Lead
Medable

The recent pandemic has not only shined a spotlight on inequities of healthcare but also the need to ensure clinical trials are reflective of the target population. In addition, regulatory authorities are more consistently insisting sponsors enroll participants that are representative of those who have the disease and could receive the therapy.

Decentralized clinical trials provide an opportunity to include those who traditionally have not participated in clinical trials, in particular accommodating lifestyle while retaining rigor of the study. Therefore, decentralized trials are a mechanism for achieving health equity and allowing for more informed treatment decisions between patients of all backgrounds and providers.

To successfully implement decentralized clinical trials, adoption of emerging technologies including remote enrollment, consent, and data capture, is critical.

Speakers:

Cherie Butts, PhD
Medical Director and Head of Clinical Assessments for Digital & Quantitative Medicine
Biogen

Derk Arts, MD, PhD
Founder and CEO
Castor

• Discuss current state of adoption of decentralized trials
• Explore potential future states based on patient preference and insights
• Review various collaborations and consortia addressing decentralized trial needs
• Consider opportunities for "meta-collaboration" across consortia to achieve meaningful adoption
• Highlight potential obstacles and countermeasures to maintain progress

Speaker:

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

Adoption of Decentralized Clinical Trials (DCT) has accelerated with the recent COVID-19 pandemic. Designing and implementing DCT's should incorporate a different paradigm that ensures patient experience is considered before the design phase to maximize recruitment, retention, and data quality.

Speaker:

Dr Brad Pruitt
Executive Medical Director, Digital Health
PRA Health Sciences

Today’s decentralized and virtual trials require a shift to direct-to-patient (DTP) distribution to keep trials moving forward. Join Marken experts to explore opportunities to optimize a supply chain strategy and facilitate both direct-to-site and direct-to-patient services utilizing a global GMP depot network. Learn the keys to successfully navigating critical paths including project management, set-up processes, and risk assessment to drive your trial forward.

Speaker:

Nina Vas
Vice President, Clinical Distribution, Cell & Gene Supply Chain
Marken

Gaurang Majmudar
Senior Director, Global Patient Centric Services
Marken

• Expanding research accessibility through patient centric approaches
• Increasing protocol compliance and retention through DCT
• Planning for the future

Speaker:

Megan Liles
Executive Director, Operational Strategy and Feasibility
Precision for Medicine

• Digital measurements: overview of key use cases
• Anatomy of measurement solutions and why it matters
• New challenges in development, management and operationalization
• How to make this easier and more accessible for everyone and boost adoption!

Speaker:

Kai Langel
Director, Janssen Clinical Innovation (JCI)
Janssen

ObvioHealth, a pioneering VRO (Virtual Research Organization) will share case studies and insider insights based on more than 30 fully virtual or hybrid studies conducted across 20 countries and 13 therapeutic areas. This webinar will answer questions like: How do you determine whether a trial can go virtual? What data collection methods are best adapted to a decentralized trial? Can virtual assistants really improve compliance? A step-by-step virtual trial playbook for sponsors wishing to embark on a DCT journey.

Speakers:

Matty Culbreth-Notaro
SVP Global Operations
ObvioHealth

Dr. Susan Dallabrida
VP of Clinical Science & Consulting
Sprim

George Masoura
Business Development
ObvioHealth

This past year has led to buzzword overload! In this session, we will cut through the buzzwords and learn about the realities of eSource direct data capture (DDC) including:

• What are the operational issues that influence our practical ability to accomplish cost-effective studies that yield actionable, reliable results — fast? And what are the most efficient ways of maximizing our chances for success?
• Why eSource DDC has become more prominent in our COVID-19 world and how this approach can be applied to your clinical trial challenges
• How BYOD ePRO fits into the eSource Ecosystem
• How real life examples, study pivots, and lessons learned will enable action within your organization

Speaker:

Jonathan Andrus
Chief Business Officer
Clinical Ink

• Feedback from patients and physicians on the pros and cons of DCT participation and the implications for long-term adoption
• Industry learnings from rapid and transformational implementation of DCTs
• Forward-looking view of the industry landscape to explore innovations that will further enhance existing DCT methodology

Speaker:

Rosamund Round
Vice President
Patient Innovation Center
Parexel

• Identifying high quality digital clinical measures for use in digital clinical trials
• Successfully operationalizing remote patient monitoring in digital clinical trials
• Common pitfalls of remote monitoring in clinical trials — examples of what not to do!
• Securing buy in to use digital technologies and decentralized approaches to medical product development: Dispelling fear, uncertainty, and doubt and demonstrating value

Speaker:

Jennifer Goldsack
Executive Director
Digital Medicine Society (DiMe)

• Insight with recent survey data
• Leveraging findings for optimised models
• Design studies to improve patient engagement and meeting study endpoints

Speaker:

E.B. McLindon
Senior Vice President, Patient, Site & Decentralized Solutions
ICON plc

THREAD and Lokavant analyse factors driving poor trial performance through data-driven analyses of decentralized and traditional trial designs. These factors are then examined in a historical study to understand how the implementation of THREAD’s DCT approaches and Lokavant’s risk-based monitoring product Oversight could have altered the performance of the study. John Reites of THREAD and Rohit Nambisan of Lokavant will present how to apply such findings to your own trials. Come and find out where your study ranked and where your study could have done better.

Speakers:

John Reites
CEO
THREAD

Rohit Nambisan
President
Lokavant

• Running clinical trials in post-Lockdown: What can we learn from other Industries?
• Incorporating hybrid patient-centric design to improve DCT success
• Using home-based monitoring technology and AI-Driven analytics in DCT
• Facing challenges with data collection: Strategies for ensuring quality, integrity, adherence

Speaker:

Amir Lahav
Healthcare Intelligence and Digital Transformation Consultant
Mitsubishi Tanabe Pharma