TransCelerate Overview - Patient Experience Initiative

Updated: May 2017
Overview
Patient Experience
Initiative

Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 2
Our Innovative Leaders
TransCelerate BioPharma is proud
to have leadership from major
biopharmaceutical companies –
who have dedicated their careers
to medicine, science and ensuring
access to life-saving medicines
through efficient and safe research
and development.
We are fortunate to have the
greatest minds in pharmaceutical
R&D dedicated towards this
common goal of identifying
common issues and model solutions
that will drive efficiencies into the
R&D process.
About TransCelerate
TransCelerate BioPharma Inc.
was launched in 2012 as a
non-profit organization with a
mission to collaborate across
the biopharmaceutical
research and development
community to identify, design
and facilitate the
implementation of solutions to
drive efficient, effective and
high-quality delivery of new
medicines, improving the
health of people around the
world.
Our Mission Statement
TransCelerate BioPharma’s mission is
to collaborate across the global
biopharmaceutical research and
development community to identify,
prioritize, design and facilitate
implementation of solutions designed
to drive the efficient, effective and
high quality delivery of new
medicines.
Our Members
TransCelerate BioPharma is
comprised of the world’s leading
biopharmaceutical companies, with
the vision of accelerating and
enhancing the research and
development of innovative new
therapies. The spirit of innovation and
collaboration occurs across
TransCelerate Member
Companies on Initiative goals.
Welcome to
TransCelerate BioPharma Inc.

TABLE OF CONTENTS
Workstream Overview
Value Proposition
Stakeholder Benefit / Impact
Deliverable Overview / Illustrative Example
Upcoming Milestones
Team Composition
Additional Resources

Enable greater patient engagement and partnership with sponsors to design and execute
clinical protocols that create better patient experiences in clinical trials.
Study
Design
Scientific
Objectives
Procedures
& Assessments
Schedule
of Activities
Diverse Patient Populations Sponsors, Sites, Investigators
Develop shared understanding of how…
Translates into…
Reduced Patient
Burden
Perception
of Value
Patient
Empowerment
Willingness to
Participate
Patient Experience Workstream Vision

Patient Experience Value Proposition
Workstream Deliverables Value Propositions
• There is no widely
accepted framework to
understand and
measure the patient
experience in trials
• Tools for clinical teams
to engage patients in
the study design and
execution stages of
clinical trials
• Frameworks to increase
the patient centricity of
study programs with a
measureable
methodology
• Better understanding
and measurement of
patient experiences in
clinical trials to increase
their willingness to
participate in clinical
trials• Without this framework it
is difficult for sponsors to
translate patient
engagement into
actionable insights that
measure improvements
in study design and
execution for patients
(i.e. ROE)
• Improved patient
experiences throughout
their clinical trial
experience
Unmet Needs

Stakeholder Benefits and Impacts
•Potential improvement in patient
recruitment, retention, & adherence
within clinical trials
•Potential reduction in long term costs
through more effective patient
engagement
•Enhanced patient feedback process
that improves outcomes across the
industry
•Increased trust and engagement
through better communication, and
participation in feedback processes
•Increased understanding of the value
in participating in clinical trials
•Potential decrease in the burden of
participating in clinical trials
•Potential increase in the sense of
altruism due to the confidence of
knowing that their participation in trials
may improve future study volunteers’
experiences
PatientsSponsors, Sites, and Investigators

PE Deliverables
Patient Centric Protocol Discussion Guide Toolkit (DGT):
• User Guide – A document with instructions that explain the most efficient and effective
ways to implement and utilize the DGT
• Discussion Guide – A discussion guide that leverages a scientifically robust framework for
engaging and eliciting feedback with patient advisors during the protocol design phase
• Patient Insights Report Template – A reporting template that includes considerations and
options on how to address patients’ concerns with protocol design choices
Patient Experience Questionnaire Toolkit (PEQT):
• User Guide – A document with instructions that explain the most efficient and effective
ways to implement and utilize the PEQT
• Patient Experience Questionnaire – A qualitative / quantitative questionnaire with a
“question bank” format used with live patients in the study conduct phase
• Summary of PEQ Results Template – A reporting template that includes lessons learned to
inform the design of the next study

STUDY PROTOCOL DESIGN PHASE
STUDY
CONDUCT
STUDY
CLOSE-OUT
ClinicalProgramTeams
Develop
(Draft)
protocol
Populate
Discussion
Guide
Engage
Patients
Protocol
Concept
Example clinical trial process with the
Discussion Guide Toolkit (DGT) and Patient
Experience Questionnaire Toolkit (PEQT)
Conduct
Internal
Assessment
of Patient
insights
Report format includes
considerations and
options on how to
address patients’
concerns with the
burdensome elements
of the protocol
As Needed
Revise/
Finalize
Protocol
Discussion
Guide
Outline
(Populated)
Discussion
Guide
Ongoing
Study
Assessments
Patient Experience Questionnaire
Conduct Exit
Survey
Summarize
Key Findings
Key findings
for next
protocol to
consider
(Populated) PEQ
Summary Findings
Report Template
Next
Protocol
Report format
includes lessons
learned and can
include optional
reconciliation with
design phase
“Patient insights
report” to inform
next study
(Populated)
Patient Insights
Report Template
Patient Experience Questionnaire (PEQ)
will be in a “question bank” format with
different potential use-cases:
• In trial patient questionnaire
• In trial site staff observer questionnaire
• Exit interview patient questionnaire
Key
Process
Initiation
Process
Completion
Phase 1
Process Step
DGT
Deliverables
PEQT
Deliverables

Upcoming Milestones
2017 Major Milestones
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
March.
Workstream plan
and delivery
timelines
established
June. .
Complete first round
of primary research
with patients, sites,
sponsors for concept
elicitation
December.
Finalize
deliverables
for 2018 pilots
October.
Complete second
round of primary
research with
stakeholders for
cognitive debriefs
July.
Complete
1st drafts of
deliverables

Who’s Involved with PE
Workstream Leads
Core Team
Fabian Somers (Allergan) & Stephen Yates (UCB)
* NOTE: Participating on the Working Groups does not require implementation of the workstream’s solutions

TransCelerate Overview - Patient Experience Initiative

More Related Content

What's hot

Similar to TransCelerate Overview - Patient Experience Initiative

More from TransCelerate

Recently uploaded

TransCelerate Overview - Patient Experience Initiative