The document discusses decentralized clinical trials (DCT) and the need for collaboration to accelerate their adoption. It defines DCT and outlines their 17-year history prior to the COVID-19 pandemic accelerating their use. In 2020, surveys found most sponsors and CROs increasing DCT and most participants experiencing changes due to the pandemic. The document advocates for pairing the right decentralized methods and tools to each study and identifies barriers to adoption like regulatory issues. It proposes a Decentralized Trials & Research Alliance to enable collaboration and proposes meta-collaboration across initiatives to streamline efforts and avoid redundancy.

1. Decentralized Clinical Trials:
Collaboration to Accelerate Adoption
Craig H Lipset
@craiglipset
02 June 2021

2. @craiglipset 2
Craig Lipset: About Me
Advisor
Faculty
Board Member Formerly
Views and positions expressed represent those of the presenter and not necessarily of the affiliations above

3. @craiglipset 3
Decentralized Clinical Trials [DCT]: Defined
Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018. https://www.ctti-
clinicaltrials.org/projects/decentralized-clinical-trials.
IMI Trials@Home. Glossary of Terms and Definitions Used. Updated April 2021.
https://trialsathome.com/wp-content/uploads/2021/04/D2.1-Glossary-of-terms-and-definitions_-2021Update_Final.pdf
[Clinical Trials] executed through telemedicine and
mobile/local healthcare providers (HCPs), using
procedures that vary from the traditional clinical trial
model (e.g., the investigational medical product [IMP] is
shipped directly to the trial participant).
Clinical Trials that make use of digital innovations and
other related methods to make them more accessible to
participants. By moving clinical trial activities to the
participant’s home or to other local settings this minimises
or eliminates physical visits to a clinical trial centre.

4. @craiglipset 4
“What’s in a name?
That which we call a rose by any other name would smell as sweet.”
The Benefits And Challenges
Of Siteless Clinical Trials
Remote Clinical Trials Market
Clinical Research Analysis 2021-2026
Virtual Clinical Trials Market
Size Worth $11.5 Billion By 2028

5. @craiglipset 5
Origin Story: Centralization Enables Decentralization
Central
site
Analogous potential for centralization
leading to decentralization in clinical trials
2008/2009 Case for Pfizer REMOTE study
Entity being decentralized: Investigator site

6. @craiglipset 6
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

7. Pre-Pandemic DCT: 17-year History Prior to COVID-19
EMWA Virtual Conference May 2021

8. @craiglipset 8
Seasons of Decentralization in 2020
Spring
of Continuity
Summer
of Restarts
Fall
of Commitment
Winter
of Pathways
to Scale

9. @craiglipset 9
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

10. @craiglipset 10
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

11. @craiglipset 11
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

12. @craiglipset 12
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

13. @craiglipset 13
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

14. @craiglipset 14
Barriers to Scaled Adoption of Decentralized Trials
Regulatory
ambiguity
Global
variability
Technology
interop &
data flow
Investigator
& patient
readiness
Endpoint
limitations
Organization
culture

15. @craiglipset 15
Decentralized Trials & Research Alliance
The Mission
The DTRA will enable
collaboration of stakeholders to
accelerate the adoption of
patient-focused, decentralized
clinical trials and research
within life sciences and
healthcare through education
and research.
The Vision
Research participation made
accessible to everyone,
enabled by the consistent,
widespread adoption of
appropriate decentralized
research methods.

16. @craiglipset 16
Decentralized Trials & Research Alliance

17. @craiglipset 17
Decentralized Trials & Research Alliance

18. @craiglipset 18
Meta-Collaboration to Accelerate Adoption
o Collaboration across the collaborations
o Each collaboration’s charter & membership bring unique strengths/limitations
o Ensure transparency
o Avoid redundancy
o Maintain clear charters and boundaries
o Trigger hand-offs

19. @craiglipset 19
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

20. Decentralized Clinical Trials:
Collaboration to Accelerate Adoption
Craig H Lipset
@craiglipset
02 June 2021