Decentralized Clinical Trials, presentaiton by Craig Lipset for mHealth Israel, April 20, 2021. Origin Story: Centralization Enables Decentralization. Analogous potential for centralization leading to decentralization in clinical trials. Decentralization: Purpose and potential benefits, including resilience and business continuity. Pre-Pandemic DCT Timeline: 17-year History Prior to COVID-19. Seasons of Decentralization in 2020. Spring of Continuity, Summer of Restarts, Fall of Commitment, Winter of Pathways to Scale. 79% of sponsors / CROs increasing DCT. 90% of participants experiencing change. 75% focus on going hybrid. 73% of Sites Will continue to use telemedicine beyond the pandemic. 76% have accelerated their DCT Strategies.Leading Implementation Strategy: Pairing DCT Toolkit to Study Needs. Identify the decentralized research methods and tools needed by the medicine portfolio. Ensure aligned SOPs & training, identify new partners, modify protocols/templates. Pair the “right” method/tool to each study based upon diverse criteria. Barriers to Scaled Adoption of Decentralized Trials: Regulatory ambiguity, Global variability, Technology interop & data flow, Investigator & patient readiness, Endpoint limitations, Organization culture. Forecasts and Futures. Choice & Flexibility for Participants on a Visit-by-Visit Basis. Research Sites Empowered to Use Their Existing Technology. New Opportunities to Engage Treating Physicians Enables Research as a Care Option. Observational “All-Comer” Studies and Platform Trials with DCT Bring Research to People.

1. Decentralized Clinical Trials
Craig H Lipset
@craiglipset
20 April 2021

2. @craiglipset 2
Origin Story: Centralization Enables Decentralization
Central
site
Analogous potential for centralization
leading to decentralization in clinical trials
2008/2009 Case for Pfizer REMOTE study

3. @craiglipset 3
Decentralization: Purpose
Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018.
https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials.
…and from 2020
Resilience and
business continuity

4. 4
Pre-Pandemic DCT: 17-year History Prior to COVID-19

5. @craiglipset 5
Seasons of Decentralization in 2020
Spring
of Continuity
Summer
of Restarts
Fall
of Commitment
Winter
of Pathways
to Scale

6. @craiglipset 6
Seasons of Decentralization in 2020
Spring
of Continuity
Summer
of Restarts
Fall
of Commitment
Winter
of Pathways
to Scale
79% of
Sponsors/CROs
Increasing DCT
Clinical Trials Europe, May 2020, n=184
90% of
Participants
Experiencing
Change
CISCRP 2020, n=38

7. @craiglipset 7
Seasons of Decentralization in 2020
Spring
of Continuity
Summer
of Restarts
Fall
of Commitment
Winter
of Pathways
to Scale
75% Focus on
Going Hybrid
ERT Survey Report: Virtual Trials and the COVID-19 Pandemic, June 2020

8. @craiglipset 8
Seasons of Decentralization in 2020
Spring
of Continuity
Summer
of Restarts
Fall
of Commitment
Winter
of Pathways
to Scale
73% of Sites Will
Continue to Use
Telemedicine
Beyond the
Pandemic

9. @craiglipset 9
Seasons of Decentralization in 2020
Spring
of Continuity
Summer
of Restarts
Fall
of Commitment
Winter
of Pathways
to Scale
76% Have
Accelerated Their
DCT Strategies
Oracle Research Report: Accelerated Evolution,
November 2020

10. @craiglipset 10
Leading Implementation Strategy: Pairing DCT Toolkit to Study Needs
1
Identify the decentralized research methods
and tools needed by the medicine portfolio
Ensure aligned SOPs & training,
identify new partners,
modify protocols/templates
eConsent
Video visits
Home health
Local labs+imaging
Remote monitoring
Digital endpoints
Central site/PI
Home drug supply
2
Pair the “right” method/tool to each study
based upon diverse criteria
Patient insights
Drug delivery
Safety profile
Intelligence
Country requirements
Regulatory feedback
Environmental risk
Organizational culture

11. @craiglipset 11
Barriers to Scaled Adoption of Decentralized Trials
Regulatory
ambiguity
Global
variability
Technology
interop &
data flow
Investigator
& patient
readiness
Endpoint
limitations
Organization
culture

12. @craiglipset 12
Forecasts and Futures
Choice & Flexibility
for Participants
on a Visit-by-Visit
Basis
Research Sites
Empowered to Use
Their Existing
Technology
New Opportunities
to Engage
Treating Physicians
Enables Research as
a Care Option
Observational
“All-Comer” Studies
and Platform Trials
with DCT Bring
Research to People

13. Decentralized Clinical Trials
Craig H Lipset
@craiglipset
20 April 2021