Patient Centric approaches to Clinical Trials: Improving Patient Experience and Overall Study Quality

1. Patient Centric approaches to Clinical Trials:
Improving Patient Experience and Overall Study Quality
Craig Elliott, PhD
Global Head of Clinical Operations, Clintec International
eCOS Brussels October 2017

2. Introduction
• There is now increased competition for patients in Clinical Trials
• The main challenge for clinical trials is to ensure that trials meet
recruitment targets and ensure patient retention
• The industry is now challenged to design protocols with the patients
in mind whilst maintaining
• scientific robustness,
• valid outcomes and endpoints,
• data integrity, and
• compliance with international regulatory requirements.

3. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
According to the Tufts Center for the Study of Drug
Development (CSDD), only 39% of sites achieve
their enrolment targets, 37% fail to meet their targets
and 11% fail to enrol a single subject into trials

4. Industry challenges
The challenge for the pharmaceutical industry is can we design trials
that:
• Ensure the patient experience is positive
• Are indicative of real world experience
• Make best use of clinical trial technologies
• Improve quality
• Meet enrolment targets
• Are truly risk based

5. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
FDA to advance patient engagement in the agency’s regulatory work
11th October 2017
• The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient
Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to
broaden its engagement with patients – and to deepen the involvement of patients in our regulatory
activities.
• Involving the end-user – the patient – in identifying health priorities and outcomes desired from health
interventions is critically important
• Today’s meeting is focused on engaging patients in the clinical trial process from design to recruitment
to enrolment and retention in clinical trials, and how we communicate about clinical trial results.
• Patients are increasingly collecting much of this real world data
• Rapid advances in smartphones enable the creation of platforms that make it easier for patients to
take ownership of their health information. It also allows us to use more of that information to advance
regulatory decision-making and product science. This is especially relevant as more information is
being collected in real-world settings, and more closely reflects the patient experience.

6. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Patient Centricity
• What is it?
A clinical study is patient-centric when, from each study
participant’s perspective, it achieves his or her goals in a
manner sensitive to his or her individual concerns and
preferences, over the entire life cycle of the study.
Journal of Clinical Research Best Practices Vol. 12, No. 4, April 2016

7. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Patient Centricity
• What is it? A patient’s point of view
Patient centricity means that clinical trials are designed in a way to attract, engage and
retain patients through the duration of the trial.
The patient should feel empowered, be an important part of the study development
process, and be treated as a partner, not as a subject.
From a patient perspective, it would be convenient to have study procedures done
remotely or at home, but limiting all clinical contact wouldn't necessarily be a good thing
since it is important to have some interaction with the investigator.
My biggest frustration with lack of patient centricity is the lack of information provided by
sponsors; we oftentimes don’t fully understand what we need to do in the study, and
there isn’t much communication.
Applied clinical trials May10 2017

8. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Improving the Patient Patient Experience
•
Creating
a patient
centric
protocol
Study objectives -
Be clear and concise
Patient input –
Patient advocacy groups
Patient support groups
Patient reviewers
Real World Experience –
Focus on outcomes
Real life situations

9. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Improving the Patient Patient Experience
• Creating a patient centric protocol
•

10. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Patient Experience and Real World Evidence
• What is the patients expectation from a clinical trial?
• Will this benefit me?
• Will this impact on my daily life?
• What should a patient be expected to go through in a clinical trial?
• How many clinic visits are needed?
• How many blood draws are required?
• What is realistic?
• Does the protocol reflect the patient’s life
• Does the protocol reflect normal everyday events
• How can we improve the overall experience?
• Patient advocacy
• Patient on the protocol design committee
• “Dry runs” of the protocol
• Designed with the patient in mind
• Technology

11. Patient Facing Technologies
PATIENT REPORTED
OUTCOMES
• Data reported
manually by the
person
themselves (or
their caregiver if
the person is
unable to enter
the data)
• Eg ePRO
TASK-BASED
MEASURES
• Objective
measurement of
a person’s mental
and/or physical
ability to perform
a test consisting
of a defined task
or set of tasks.
• Task-based
measures require
cooperation and
motivation
• Eg Apps within a
smartphone
ACTIVE SENSOR
DATA
• Measurement of
a person’s daily
activities,
• mental state,
• physiological
status that
requires an
activation step
• Eg glucose
monitors, peak
flow meters
PASSIVE SENSOR
DATA
• Measurement of
a person’s daily
activities, mental
state, or
physiological
status that does
not interrupt the
person’s normal
activities (i.e., it
measures what
the person
actually does in
daily life)
• Eg wearable
devices
Mobilizing mHealth Innovation for Real-World Evidence Generation Duke Margolis Centre for Health Policy

12. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential

13. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Technology
• Technology should be used to make life simpler for the patient
• Can the patient use the technology
• What training is needed
• Technology should be used to capture information remotely
• Does the data needed to be downloaded or transmitted
• Internet connectivity or work remotely
• Technology must be fit for purpose
• Does the technology facilitate what is needed
• Technology must be simple
• Can it be used by multiple patients in multiple locations
• Make use of telemedicine
• Can visits be performed remotely
• Skype

14. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Patient Centric
Risk based approach
•
Reduced
risk
Trials based on real life experience
Focused outcomes
Reduced number of data points
Better and quicker reporting of data
Fewer protocol deviations
Better compliance
Increased patient retention
Simpler monitoring

15. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Improving quality
Study
designed
around the
patient
Clinical
outcomes
Focus on
clinical
normality
Aims of the
study are
simplified
Patients
can comply
with the
protocol
Patient
population
exists
There is an
unmet
medical
need
Increased
probability
of patient
recruitment
Increase
patient
retention
Better data,
quicker
Less
redundant
data points
Improved
quality and
improved
timelines

16. eCOS presentation Brussels October 2017 Clintec International Ltd Confidential
Craig Elliott
Global Head of Clinical Operations
Clintec International Ltd
Celliott@Clintec.com