White Paper

Unlocking the Potential of
Decentralized Clinical Trials
Anna Osborne, PhD
Managing Consultant, Citeline

Susan Danheiser
Trialtrove Director, Citeline

March 2023

Unlocking the Potential of
Decentralized Clinical Trials

Introduction
The concept of a Decentralized Clinical Trial (DCT) has been around in the industry for a numberof years, since Pfizer conducted the first “virtual” trial in June 2011. But DCTs have finally started
to move out of paralysis in pilots and have increasingly become a more mainstream consideration
since the COVID-19 pandemic. A DCT is simply a trial that has activities conducted remotely, suchas in participants’ homes, yet the reality of achieving this has not been simple at all. DCTs werediscussed extensively at recent conferences including CNS and Clinical Trials Europe, and it was
clear that all industry stakeholders are keen to stay abreast of this evolving field and continue
driving the change to ensure full adoption.
As this white paper shows, the number of trials with decentralized attributes has been gradually
increasing over time, but despite this rise, we are still in the very early stages of adapting trial design
strategies to better fit around the new digital world. Based on Citeline’s validated methodology for
assignment of DCT classification, the proportion of studies incorporating decentralized elements
remains very low. Citeline’s proprietary data suggests this was only 3.4% for trials that started in
2022 and were reported to date in the public domain.
This paper explores the current DCT landscape and its evolution over time, as well as the key
advantages of incorporating decentralized attributes and how barriers to their inclusion can beovercome. The narrative is supported by data and analysis from Citeline’s gold-standard clinical
trials intelligence solution, Trialtrove, and validated by Citeline’s industry leading customer network.

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Decentralized Clinical Trials

Trends in DCT Design
The exact characteristics that a trial needs todisplay to be considered a DCT is a subjectof active debate. The Decentralized Trials &Research Alliance (DTRA) suggests a DCT isa clinical trial utilizing technology, processes,
and/or services that create the opportunity to
reduce or eliminate the need for participants tophysically visit a traditional research site, andas such decentralization can be considered aspectrum.1

designed to provide views into specific sectors/
elements of the DCT landscape. These comprise:
Telemedicine/Telehealth, Wearables/Sensors(used remotely), Personal Devices/Apps (usedremotely), Home Visits, and Electronic Consent.

To reflect this spectrum, Citeline has createdan extensive dictionary of DCT-related terms
based on the content observed across clinical
trials in Trialtrove and supported by internal andpublicly available references. This dictionary isused in the mining of relevant text fields within
Trialtrove for the presence of DCT attributes.
This allows the creation of a DCT filter, whichreflects the currently available, publicly disclosed
information included in Trialtrove. DCT-related
terms are aggregated across five key categories

Interestingly, the actual incorporation of DCT
attributes is not in line with the extensive
attention decentralized trial designs arereceiving. The number of trials incorporating one
or more DCT element has increased slightly from
376 trials starting in 2016 to 526 trials startingin 2021 (Figure 1); however, the vast majorityof trials still do not incorporate DCT attributes,
or at least there is no easily accessible public
disclosure of this. It should be noted that certain
DCT elements are less likely to be described insources like trial registry postings and might
only be described in full protocol documents.
That said, adoption appears to be low, despite
the potential advantages to sponsors andpatients that have been widely communicated.

4.0%

600
3.1%
500
400

2.7%

2.7%

2.9%

3.4%

2.8%

3.5%
3.0%

2.6%

2.5%
2.0%

300

1.5%

200

1.0%
100

0.5%

% of trials with DCT attributes

Number of trials with DCT attributes

Figure 1: Trials incorporating DCT attributes over the last seven years

0.0%

0
2016

2017

2018

2019

2020

2021

2022

Trial start date
Source: Trialtrove, February 2023
Please note, Trialtrove captures data as it becomes available in the public domain. As such, the number of trials in Trialtrove
with a start date of 2022, for instance, is likely to increase over time as more data is made available.
1. DTRA (2022) Glossary. Available from: https://www.dtra.org/1a-glossary#letter-D [Accessed 02 February 2023].

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Decentralized Clinical Trials

Both industry and academic sponsors havebeen investing in DCTs, as shown in Figure 2.
The percentage of industry-sponsored trials
incorporating DCT attributes has remained
relatively stable over the last seven years,
fluctuating between 2.5% and 2.9%. This
contrasts the uptake in academia, whichrose from 2.8% in 2016 to 4.5% in 2022. It
is therefore DCTs in the non-commercial
setting that are driving the increase in trials
with associated DCT attributes. One possible
contributor to this trend is the greater capacity

for flexibility among academic sponsors,
compared to large biotech or pharmaceuticalcompanies. Industry sponsors typically havecomplex operating models which limit the useof unvalidated tools such as novel electronicclinical outcome assessments, and they are
more likely to run pivotal trials for registration
requiring compliance suitable for submissions toregulators. Academic groups are more likely to
conduct smaller early-phase or late-phase postmarketing studies, and these inherently allow for
greater adaptability.

250

5.0%

Number of trials with
DCT attributes

4.5%
200

4.0%
3.5%

150

3.0%
2.5%

100

2.0%
1.5%
1.0%

50

0.5%
0.0%

0
2016

2017

2018

2019

2020

2021

% of trials with DCT attributes

Figure 2: Sponsor type for trials incorporating DCT attributes over the last seven years

2022

Trial start date
Industry sponsor

Academic sponsor

Industry sponsor

Academic sponsor
Source: Trialtrove, February 2023

Please note, Trialtrove captures data as it becomes available in the public domain. As such, the number of trials in Trialtrove with a start dateof 2022, for instance, are likely to increase over time as more data is made available. In addition, a single trial may be associated with both anindustry and academic sponsor.

Among the industry sponsor subset, certain
companies are embracing this new approach totrial design more than others. Pfizer, Novartis,
and Takeda emerge as the three companies
with the most ongoing and planned trials with
DCT attributes. Interestingly, Merck and Bristol
Myers Squibb rank second and third in their

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total number of ongoing and planned trials, andyet they do not sit within the top 10 sponsors
for trials with DCT attributes (Table 1). This may
indicate a more cautious approach to newclinical technologies, but these companies arealso heavily concentrated in oncology, where
decentralization is less mature.

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Decentralized Clinical Trials

Table 1. Top 10 sponsors, by number of studies, for all ongoing and planned trials
Ranking

Trials with DCT attributes

All trials

1

PfizerAstraZeneca

2

Novartis

Merck & Co

3

TakedaBristol Myers Squibb

4

AstraZeneca

Roche

5

Roche

Pfizer6

Eli Lilly

Novartis

7

Sanofi

Jiangsu Hengrui Pharmaceuticals

8Johnson & Johnson

Johnson & Johnson

9

AbbVieSanofi

10

GSK

AbbVie

Source: Trialtrove, February 2023

With regards to the key attribute categories
associated with DCTs, Personal Devices/Apps
lead the way in terms of current adoption withinclinical trials (Figure 3). Inclusion increased from
0.7% in 2016 to 1.5% in 2022, which is the highest
inclusion rate of all assessed DCT attributes.
In 2018 and 2019, smoking cessation was
associated with the most trials incorporating
Personal Devices/Apps; however, the pandemic
quickly changed that, and COVID-19 became
the top indication in 2020 and 2021, accounting
for 37% and 28% of trials incorporating Personal
Devices/Apps respectively. Use of Telemedicine/
Telehealth was also affected by the pandemic.
119 trials that started in 2019 incorporated
Telemedicine/Telehealth, and this jumped to 161
in 2020, of these 59 were for COVID-19.

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The inclusion of Wearables/Sensors hasremained more constant, hovering at slightly
over 1%. Type 1 and type 2 diabetes trials
dominated this category, owing largely to use
of at-home continuous glucose monitoring. The
percentage of trials incorporating home visits
remained consistently low between 2016 and2022, tracking at approximately 0.1%. It may bethat their inclusion is not being fully represented
in registries and other key publicly available
sources that our Trialtrove analysts mine, but
it is also likely that there are considerable
operational barriers to uptake and that the
pandemic did not help in that respect. Inclusionof electronic consent has also remained low,
despite having a low technological hurdle, andmay also be under-reported.

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Decentralized Clinical Trials

Figure 3: Percentage of clinical trials incorporating various DCT attributes over the last seven years% of trials incorporating attribute

1.6%
1.4%
1.2%
Telemedicine/Telehealth

1.0%

Wearables/Sensors

0.8%Home Visits
Personal Devices/Apps

0.6%

Electronic Consent

0.4%
0.2%
0.0%
2016

2017

2018

2019

2020

2021

2022

Trial start date

Source: Trialtrove, February 2023

Together, the three therapeutic areas of CNS,
Metabolic/Endocrinology, and Autoimmune/
Inflammation are associated with a large
proportion (68%) of the trials that have DCT
attributes (Figure 4). DCT attributes have been
incorporated into trials for a wide range of CNS
indications such as nociceptive and neuropathic
pain, insomnia, multiple sclerosis, Alzheimer’s
disease, migraine, and depression. The range of
DCT attributes for this therapeutic area is alsobroad and includes electronic diaries, mobile
devices, actigraphy, and telephone interviews
to name but a few. DCT attribute inclusion in
the Metabolic/Endocrinology therapeutic area
is being driven by use of continuous glucose
monitoring which involves a wearable/implant
for type 1 and type 2 diabetes, while inclusionof DCT attributes in Autoimmune/Inflammation
trials is largely attributable to the use ofelectronic diaries in asthma and COPD.

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The therapeutic areas associated with the least
trials with DCT attributes include Ophthalmology
and Genitourinary, although of course, these
therapeutic areas are also associated with fewer
trials overall. The low positioning of Oncology,
with just a 5.4% overall share, is also notableconsidering that almost four in 10 new trials areinvestigating cancer therapeutics. This speaks
to the challenges of decentralization in trials
with complex inclusion criteria and protocols
relying heavily on in-person infusions andclinical assessments. However, to some extent
this figure masks the extent to which oncology
trials adopted DCT attributes throughout
the pandemic due to the critical nature of
the therapies for late-stage cancer patients.
Sponsors had to quickly pivot to home nursing,remote patient outcomes collection, and direct
IMP shipment to patient homes.

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Decentralized Clinical Trials

Figure 4: Therapeutic area representation among industry-sponsored trials with DCT attributes
CNS
Metabolic/Endocrinology
Autoimmune/Inﬂammation
Infectious Disease
Cardiovascular
Vaccines (Infectious Disease)
Oncology
Genitourinary
Ophthalmology
0

100

200

300

400

500

600

700

800

Number of trials with DCT attributes
Source: Trialtrove, February 2023

With regards to trial phase, sponsors are most
likely to include DCT attributes in later-stage
trials, in particular Phase IV trials (Figure 5).
The main objectives of a Phase IV study are
to check the drug’s performance in real-lifescenarios, to study the long-term risks andbenefits of using the drug, and to discover
any rare side effects. This results in these trials

being typically longer in length, which makes
the need to continually visit the study site agreater burden. Furthermore, as regulatory datasubmission requirements are less prescriptive
for post-marketing studies, due to the nature ofmonitoring real-world surveillance, there is more
scope for the trial sponsor to be enabled withdigital endpoints that are not yet validated.

Figure 5: Percentage of industry-sponsored trials incorporating DCT attributes by phase% of trials incorporating
DCT attributes

6%
5.0%

5%

4.5%

4%

3.5%

3%
2%
1%

1.9%

2.1%

II

II/III

1.1%
0.4%

0%
I

I/II

III

III/IVIV

Trial phase

7

Source: Trialtrove, February 2023

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Decentralized Clinical Trials

When looking at the geographical landscapeof trials with DCT attributes, it is clear that
there are regional differences (Figure 6). Asian
countries, including China, South Korea, andeven Japan, are lagging behind and havebeen more resistant to pivot towards novel

trial designs. Panelists at the Clinical Trials
Europe conference discussed how regulatory
authorities in these markets are less open to
new approaches and this creates a lack ofharmonization which is a challenge for sponsors
planning global clinical trials.

Figure 6: Percentage of ongoing or planned industry-sponsored clinical trials incorporating DCT
attributes by country.

4.5%

Canada (8)United Kingdom (4)

4.0%
3.9%

Germany (5)Italy (9)3.6%Spain (3)

3.6%
3.1%

United States (1)France (6)3.0%Japan (10)2.9%South Korea (7)1.5%China (2)

0.5%
0%

1%

2%

3%

4%

5%

% of trials incorporating DCT attributes
Source: Trialtrove, February 2023

Note: For the countries with the highest number of trials. Each country has been assigned a number which reflects its ranking based on the total
number of ongoing or planned trials.

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Decentralized Clinical Trials

Why Incorporate DCT Attributes?
The proponents of decentralization point
towards numerous ways in which the adoptionof technology improves the clinical trial process.
Here we summarize the key benefits to DCT
attribute inclusion.
Greater patient flexibility
Traveling to a study site is a major barrier toclinical trial participation. The traditional modelin which patients must typically attend multiple
on-site appointments is burdensome and canheavily interrupt patients’ daily activities.
Wendi Lau, Senior Director of ClinicalDevelopment Operations at AbbVie, explained,“We need to make trials fit around lives
rather than lives fit around trials” during her
plenary presentation at Clinical Trials Europe inNovember 2022.
The DCT approach is fundamentally patientcentric, using virtual tools like wearable
technical devices and telemedicine to conduct
remote visits and monitor data, allowing
for increased flexibility and convenience ofparticipation.
Improved patient acquisition and retention
DCTs have the potential to decrease the burdenthat trial participation places on patients,
by requiring fewer or no site visits. Many are
hopeful that this will contribute not only tohigher enrollment, but also to higher patient
retention.

trial said this was because they were unable tofind a nearby trial location.2 This was by far thegreatest limiting factor, more so than inclusion/
exclusion criteria and uncertainty aroundthe clinical trial process. If DCTs can help tosolve problems associated with the proximityof available studies, then gains in patient
recruitment and retention can be rapidly realized.
More diverse trial sets
The DCT model is especially helpful for patients
who do not live near a clinical trial site, havemobility issues, or have cultural preferences thatprevent them from taking part in a traditional
clinical trial.
A 2022 Tufts CSDD Impact Report found that
more than half of pivotal trials supporting EU
Commission approval underrepresent non-white
racial identities by more than 20%.3 The ability
to collect a more diverse data set will increase
external validity and ensure minority groups are
not underrepresented.
“Unfortunately, for a lot of people,
underrepresentation of some groups wasn’t
brought up much prior to the pandemic eventhough race has been an issue from almost the

In a study conducted by Citeline and Rare
Patient Voice regarding patients’ attitudes
towards clinical research, almost half of all
patients who had not participated in a clinical
2.	Citeline (2021) Patient Perspectives on Clinical Trial Participation. Available from: https://pharmaintelligence.informa.com/resources/productcontent/2021/07/22/16/07/patient-perspectives-on-clinical-trial-participation-report [Accessed 16 January 2023].
3.	Tufts (2022) In Europe, Demographic Under-Representation in Clinical Trials Persists. Available from: https://csdd.tufts.edu/impact-reports[Accessed 11 January 2023].

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Copyright ©️ 2023 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)Unlocking the Potential of
Decentralized Clinical Trials“We shouldn’t try to replicate the same kindof protocol in this new setting. This new wayof doing research allows us to measure things
better and have deeper and more continuous
insight into the patient’s life and health,” said
Kai Langel, Senior Director of Strategy andInnovation, Global Regulatory Policy andIntelligence, Janssen R&D, during a Clinical
Trials Europe panel session.
onset of clinical research,” LaShell Robinson,
Head of Diversity and Inclusion in Clinical Trials
at Takeda, told In Vivo.4
DCT approaches have the ability to enable
identification of patients nationally, throughleveraging digital recruitment strategies, andengage patients through online ads, social
media, and interaction with patient advocacy
groups. Sponsors can use these tools to tailor
their message to the desired demographic.
Robin Sutherland, Vice President of Human
Resources and Clinical Operations at Renovia
shared her company’s experience of a virtual
clinical trial in gynecology in a presentation
at Clinical Trials Europe. Renovia successfully
used a targeted zip code approach to increase
uptake in minority groups in their remotewomen’s health study to evaluate the efficacy ofan at-home digital device for the treatment ofurinary incontinence.
Science done better
The DCT approach gives sponsors theopportunity to think about study designs
differently and to improve upon their current
approach for data collection. A more flexible
design also supports “optionality” of methods
for patient participation and in turn improves
retention, in addition to faster recruitment.

For instance, patients with depression havehistorically been evaluated using a weekly
MADRS or HAM-D score. This rating scale isnotoriously subjective to administer and is prone
to fluctuations that lower the reliability of any
measure at a single time point. But with theintroduction of new approaches, sponsors havethe potential to better capture the range ofsymptoms that patients experience with more
frequent at-home monitoring.
Smaller trials
Incorporating DCT attributes should enable thecollection of better data and enable researchers
to see differences between study groups moreeasily. Ultimately it could reduce the numberof patients needed in each study arm via
innovative methods such a synthetic placeboarm, or more traditionally as it reduces dropouts
and therefore improves the statistical power ofthe study design.
Lisa Moneymaker, Senior Vice President of Clinical Operations Technologies at Medidata, told
Medtech Insight, “With the data that we havein-house, we can extrapolate an entire arm of astudy that is totally synthetic and doesn’t requirea patient to enroll against a placebo or standardof care. This will have the greatest impact onpatients suffering from serious conditions. Often
times it’s not about curing patients, it’s about
extending their quality of life”.5

4.	In Vivo (2022) Available from: https://invivo.pharmaintelligence.informa.com/IV146746/Racial-And-Ethnic-Diversity-In-Clinical-Trials-A-SocialAnd-Scientific-Imperative [Accessed 11 January 2023].
5.	Medtech Insight (2022). Available from: https://medtech.pharmaintelligence.informa.com/MT145819/Decentralized-Trials-Are-Here-To-StayWhat-Challenges-Do-They-Face [Accessed 11 January 2023].

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Decentralized Clinical Trials

Challenges for Decentralization
Despite seeing an increase in trials
incorporating DCT attributes in certain pocketsof the industry, sponsors don’t always takethe opportunity to incorporate decentralized
elements into clinical trial design. There are stillbarriers that need to be broken down in order tofully embrace the opportunity that DCTs offer,
which we investigate further here.
Oversight
Healthcare is typically managed via aseries of a face-to-face interactions withhealthcare professionals, and the paradigm
for clinical trials is based upon this experience.
Stakeholders across the industry are concernedby the lack of perceived oversight with DCTs andthere is a lack of trust in results that come out ofwhat seems to be a less controlled environment.
However, it is important to emphasize thatwhile oversight may look different, it is notcompletely lost, and that when face-to-facecontact is required it should be maintained. Thatbeing said, it should still be possible to look foropportunities to increase flexibility to benefit
patients, whether that be through telemedicine/voice calls, visits outside of a clinic setting, or
use of local healthcare services.

The paper will help trial sponsors and otherstakeholders navigate the EU’s complex
landscape relating to DCTs. Crucially, it includes
an appendix on whether certain decentralized
elements – such as electronic informed consent,delivery of the investigational medicinal
product, conducting trial-related procedures athome, and trial monitoring – are permitted indifferent EU member states.
The FDA issued draft guidance in December
2021 on digital health technologies for remote
data acquisition in clinical investigations,but further guidance on decentralized trials
is needed.7 Even with this guidance in place,regulatory success will still be dependent onplanning early, keeping track of evolving local
requirements and initiating discussions withregulatory authorities to seek feedback.
The regulatory review process is often presented
as a bottleneck, but Lada Leyens, Senior
Regulatory Program Director at Roche, thinks
regulators are increasingly open to new andwell-thought-through trial designs. She believes
presenting a considered approach is key toconvincing regulators that sponsors are able

Regulators
In order to support the push towards
harmonization, EU regulators have recently
published their much-awaited perspectives on
the use of decentralized elements in clinical
trials undertaken in the EU/European Economic
Area.6 The recommendation paper, publishedon 14 December 2022, is a joint initiative of
the European Medicines Agency, the European
Commission, and the EU Heads of Medicines
Agencies.
6.	European Commission (2022) Recommendation paper on decentralized elements in clinical trials. Available from: https://health.ec.europa.eu/
latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en [Accessed 11 January 2023].
7.	FDA (2021) Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. Available from: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations [Accessed 11 January2023].

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Decentralized Clinical Trials

to manage data integrity and risks associatedwith patient safety no matter how a trial isconducted.

Compliance
There has been concern that there may be
a lack of compliance when you remove theoversight of having to go to the physician.
However, compliance is a challenge regardlessof how a trial is implemented, and complianceshould not be harder to manage withdecentralized approaches. Use of connected
devices that collect data automatically, rather
than having to rely on the completion of
paper or electronic diaries, has the potential
to increase compliance, and notifications orreminders can be used to encourage compliant
practices.

“Let me burst a myth. I always hear regulators
are the bottleneck, regulators are not open.
Actually they are very open to well-designed
and well-thought-through designs that are fit
for answering the scientific question and that fit
within the framework of Good Clinical Practice,”
said Leyens during a Clinical Trials Europe panel
discussion.

Asking patients to remember their symptoms
over a two-week period is much less accurate
than collecting data at home in a continuous
manner. Patients may also be subject towhite coat syndrome for blood pressure
measurements, and this could bias the data andultimately result in it being less consistent andaccurate than what could be collected at home.

Cost
The implementation of decentralized attributes– going above and beyond traditional study
design approaches to reduce patient burden– is likely to add to overall study costs in thefirst instance. However, it is important to lookbeyond this to future opportunities. Ultimately,
trials should recruit faster with access to awider population, and this will get the medicine
to patients quicker, assuming the clinicalprogram is a success. The cost/benefit of
DCTs is dependent upon clinical efficiency andimproving R&D productivity.

Re-imagining the trial design paradigm
also presents the opportunity to reduce trial
complexity which hinders compliance. Many
elements of study design are nice-to-have, but
not essential. This is an opportunity for sponsors
to strip back this complexity and instead focus
on patient-centricity.

“Over time as these opportunities become more
and more embedded as a way of working, it’s
likely sponsors will lose patients because they
will be competing against trials that are offering
more flexibility to patients,” said Wendi Lau
during her plenary presentation at Clinical Trials
Europe.

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Patients
Not all patients want to have healthcare
administered outside of a clinic or a traditional
healthcare setting, and so it is important todesign trials that are as flexible as possible within
the realms of what is trying to be achieved. One
size doesn’t fit all, and decentralization may
present a barrier for the participation of certain
patient demographics. For example, protocols forclinical trials that enroll elderly patients must be
mindful of potential technological requirements
for study participants such as smartphones.
Similarly, a fully remote trial experience may beless engaging for patients with conditions that
benefit from human interaction with healthcare
providers.

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Decentralized Clinical Trials

The site perspective
A survey of 340 site professionals conducted by
the Society for Clinical Research Sites (SCRS)
in 2020 reported that respondents’ primaryconcerns regarding DCTs included patient safety
and study quality.8

are expected to become familiar with. Thereis no consistency in the approach taken bydifferent sponsors, and the management of thetechnology used in DCTs has become logisticallycomplex. Challenges often arise in relation to
storage and training.

More recently, a survey undertaken by the
US-based Association of Clinical Research
Professionals (ACRP) published in November
2022 showed that research sites and clinicalresearch professionals are facing an increased
burden in delivering DCTs.9

Some sites already have services available
for use as part of their organization such as
telemedicine, electronic informed consent, homehealthcare services, and travel arrangements,
and it will be important to make use of theseand to avoid the use of multiple devices forparticipants and sites where possible.

To support greater uptake, the ACRP said it
was important to involve all trial stakeholders
in decision-making from the start, rather thanhaving ‘solutions’ imposed on the sites. The
ACRP also recommended sites have more
flexibility in managing third-party vendors andcontrolling budgets.
It will be important for sponsors to notalienate study sites as they will be reluctant
to offer DCT options to patients unless they
think this approach meets safety and quality
requirements and will reduce their burdens.
Technology
DCTs are closely aligned to digital use of apps,
eConsent, eDiaries, ePROs, sensors, etc. This
technology is essential to monitor patients andgather patients without limits on geography.
There has been a movement towards collecting
data digitally, but further progress still needs tobe made.
Currently, a big challenge for sites, particularly
those running large numbers of studies, is thevolume of devices and new technology that they

Data security
Data breaches regularly make the headlines
across all industries, leading to valid concerns
around data security and privacy. A key
question all organizations face is how to bestprotect people’s data and how to manage multiparty privacy consent.
“We don’t just have to provide information on
data security and privacy to the regulatory
authorities but to the patients themselves.
Where is your data going to and from at any
given point? Who could have access to it?
How are we safeguarding that? How do wequalify vendors if they are holding it? Who is acontroller? Who is a user? It becomes very, very
complicated,” commented Rebecca Jackson,
Senior Manager of Novel Trial Modalities andInnovation at Janssen, during a panel session at
Clinical Trials Europe.
Critically, it will be important to treat patientsas partners and to communicate the role ofdata collection in developing new and effective
treatments.

8.	SCRS (2022) Impact Assessment of Decentralized Clinical Trials (DCT). Available from: https://myscrs.org/press/press-releases/scrs-and-virtrialrelease-white-paper-on-the-impact-of-decentralized-trials/ [Accessed 8 February 2023].
9.	ACRP (2022) Delivering on the Promise of Decentralized Trials: Unexpected Perspectives from Clinical Research Professionals. Available from:https://acrpnet.org/delivering-on-the-promise-of-decentralized-trials-unexpected-perspectives-from-clinical-research-professionals/ [Accessed
11 January 2023].

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24/7 data collection
With the incorporation of DCT attributes there is
the potential, in some instances, for data to becollected in real-time, but does this mean thatit also needs to be monitored in real-time, andwill there be an expectation among patientsthat their data is monitored for signs of an
emergency? There has been concern among

study investigators who rightly “clock off” at theend of their shifts that they will be expected toshoulder this burden. Clearly this is not feasible,
and realistic expectations around the frequency
with which data can be reviewed will need to be
set. But there may be opportunities to use tools
such as machine learning to monitor and flag
concerning data.

Key Takeaways
Incorporating DCT attributes offers a patient-centric approach, addressing various patient needs
that often go unmet in traditional designs. These trial designs also have the potential to benefit
sponsors by accelerating clinical development, enabling more representative patient access, anddeveloping a stronger evidence package than traditional trials.
However, right now, the adoption of DCT elements is very low. Citeline’s proprietary data suggests
it was only 3.4% for trials that started in 2022 and were reported to date in the public domain,and uptake among industrial sponsors is particularly low. Clearly, there is a long way to go, andcontinued communication and demonstration of the benefits of DCTs, and flexibility in overcoming
the hurdles to their implementation, is required. Hype from CROs will only take us so far, now it will
be necessary to prove the benefits instead of just talking about them.

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Copyright ©️ 2023 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)Unlocking the Potential of
Decentralized Clinical Trials

Meet the Authors
Anna Osborne, PhD
Managing Consultant, Citeline

Anna is a Managing Consultant in the Citeline/
Evaluate Consulting and Analytics team, ateam which specializes in pharmaceutical andhealthcare consultancy. Within her role Anna
answers key asset, portfolio, and corporate
strategy-related business questions.
Prior to joining the Consulting and Analytics
team, Anna was an analyst at Citeline’s
Pharmaprojects. Here, she expertly curated thedrug development database, provided researchsupport to clients, and produced custom
analytics projects, transforming clinical study
data and drug data into actionable insights.

Susan Danheiser
Trialtrove Director, CNS, Autoimmune/
Inflammation and Ophthalmology, Citeline

Susan has been with Citeline since 2004,
where she has assumed various roles
including early development of Trialtrove’s
oncology content, managing Citeline’s
custom analytics/consulting services, anddriving key product enhancements. She
currently serves as Trialtrove Director for
the CNS, Autoimmune/Inflammation andOphthalmology therapeutic areas.

15

March 2023 

Copyright ©️ 2023 Pharma Intelligence UK Limited, a Citeline company (Unauthorized photocopying prohibited)Citeline powers a full suite of complementary business intelligenceofferings to meet the evolving needs of life science professionals
to accelerate the connection of treatments to patients andpatients to treatments. These patient-focused solutions andservices deliver and analyze data used to drive clinical,
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Our global teams of analysts, journalists and consultants keep
their fingers on the pulse of the pharmaceutical, biomedical
and medtech industries, covering it all with expert insights: key
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and more. For more information on one of the world’s mosttrusted life science partners, visit Citeline.com

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