1.
Innovation in Clinical Trials
Are wearables the answer to the issues facing clinical trials?
Gary Monk
February 19th

2.
Clinical Trials are plagued by under recruitment, delays and
dropouts. One key barrier is participants distance from trial sites
85%
Of clinical trials fail to
recruit enough
patients1
80%
Of all clinical studies
fail to finish on time1
(& 20% delayed for 6
months or more)
30%
Is the average
dropout rate of all
clinical trials1
Sources:
1) ClinicalLeader.Com
2) FierceBiotech
Of potential
participants live over
2 hours away from
the study site2
70%
@garymonk

3.
It is not only Geography: There are barriers across each stage
from Identification to Retention
Identify
Engage
Enroll
Retain
Barriers at Each Stage
Often the right patients can’t be identified and reached in
the first place. Social Media is a great tool for this but only
11% of trials use Social Media to reach potential patients
Once the patient is reached they are often not engaged in the right way,
i.e. quickly with clear benefits for participation & enrolment made simpler
The key barrier to participation in a trial is geography, i.e. distance of patients
home to trial sites
Geography remains an issue with patients tiring of follow up visits. An important insight
is the patient needs to see benefits for their continued participation. Simplicity and
convenience alone do not cut it
Sources:
1) AppliedClinicalTrialsOnline
@garymonk

4.
Trials that use wearable technology & sensors to monitor patients at
home, solve the issue of distance & improve the patient experience
Potential Benefits of Wearables in Clinical Trials
Increased and faster
recruitment (patients
don’t have to travel to
centers)
Higher compliance rate >
Easier for patients
particularly where wearables
collect passive data
Reduced dropout rate,
remote monitoring via
devices = < hospital visits
The large amount of additional data
could mean a lower variability, so
fewer subjects could be needed to
achieve statistical power
In addition the creation of Novel
endpoints, e.g. mobility as a measure
of QoL, extended sleep monitoring
@garymonk

5.
Before we get too excited, there are downsides, at least at the
moment….
Potential Issues of Wearables in Clinical Trials
New Processes
Huge volumes of data
need new techniques
for storing, processing
and analyzing
New Skills
Clinical teams not familiar
with collecting and analyzing
large data sets
Standardization
Lack of industry standards
for devices in terms of
terminology data processing
Data Privacy
Data ownership and sharing, consent
requirements and the variability of
these laws across geographies
Data Security
Particularly important for patients in a
clinical trial setting
@garymonk

6.
The Number of Digital Health trials using Wearables to capture
patient data is increasing year on year
8
16
26
45
61
95
125
162
0
180
2011 2012 2013 2014 2015 2016 2017 2018
The number of trials using wearables starting in given year
In 2019, 52 ‘wearable’
trials are already
underway or scheduled,
suggesting a sharp future
increase
Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk

7.
Despite this increase a very small number of clinical trials are using or
have used wearables & Pharma are only just beginning to explore
604296,960 29
Total Trials Trials using
Wearables
Pharma Trials
using Wearables
0.2% 0.01%
Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk

8.
23 Pharma companies have experience in wearable clinical
trials. The majority with only 1 trial
4 Trials (1) 2 Trials (5) 1 Trial (17)
Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk
Note: 2 partnership trials.
GSK/Gilead and
Lundbeck/Otsuka

9.
Digital Health studies cover a significant breadth of conditions
Source: ClinicalTrials.Gov extracted 2/9/19
Disease Area # of Trials Companies Active
HIV 3 Gilead / GSK
Parkinsons Disease 3 Abbot/Biogen/UCB
Rare Disease 3 Actelion/Bayer/Theravance
Schizoprenia/Bipolar/MDD 3 Lundbeck / Otsuka/ Takeda
Dermatology 2 LEO / Pfizer
Diabetes 2 Eli Lilly
Heart Failure 2 Novartis / Precigen
Pain Management 2 Mudipharma / Purdue
Angina 1 Gilead
Autism 1 Roche
Cancer 1 Genentech
COPD / Asthma 1 GSK
Growth Hormone Deficiency 1 Pfizer
Hemophilia 1 Bayer
Kidney Disease 1 ZS Pharma
Migraine 1 Allergan
Stroke 1 Janssen
@garymonk

10.
Where wearables are used to capture patient data the US
dominates. Canada, Israel & UK are strong ‘runners up’
351
35 33 32 16 15 14 13 12 9
US Canada Israel UK South Korea Italy France Switzerland Germany Belgium
Top 10 Countries using Wearables in clinical trials (all time # of trials)
Total # of Trials
Trials per million population
US Canada Israel UK S Korea Italy France Switzerland Germany Belgium
1 2 3 4 5 76 8 9 10
Source: ClinicalTrials.Gov extracted 2/9/19 @garymonk
1.1 1.0
3.8
0.5
0.3 0.25
1.5
0.15
0.8
0.2

11.
Key Takeaways
@garymonk
• Clinical Trials have number of critical issues around recruitment & retention
• Geography is a big issue (patients distance from Trial Sites) that wearable
technology can help solve, by allowing clinical data to be captured in the
patients home
• Trials using wearables are increasing year-on-year but only represent a small
number of all trials (0.2%)
• Pharma only limited involvement in trials using wearables (ca. 30) with 23
companies active across a broad range of therapy areas

12.
Notes:
@garymonk
• ClinicalTrials.gov is a comprehensive source but may not be an
exhaustive list of ALL wearable tech trials
• This research was based on wearable devices, other Digital Health trials
exist, e.g. using remote sensors, smart devices (e.g. inhalers) that are
not included here. These numbers are also small

13.
Feel free to connect!
@garymonk
@garymonk
linkedin.com/in/garywmonk/