VIEWPOINT2024

A C C E L E R AT I N G C U R E S
Speeding up the path to new treatments

Patient recruitment drives success in clinical
trial execution — but is increasingly difficult. To
overcome this challenge and achieve wins, clinical
trial sponsors must inspire study teams to beatclinical trial patient-recruitment timeline targets.
This Viewpoint provides insights, case studies,and data outcomes of clinical trials that achieved
accelerated patient recruitment and shows how
this was accomplished.

AUTHORS
Ben Enejo
Emmanuel Aisabokhae
Shreya Modi

ARTHUR D. LITTLE

VIEWPOINTT H E K E Y S TA K E H O L D E R S
I N T H E H E A LT H C A R E
SYSTEM ALL BENEFITFROM A WIN IN
O N -T I M E C L I N I C A L
TRIAL E XECUTION

According to legendary US college basketballcoach Bobby Knight, the key is not the will to win… everybody has that. It is the “will to prepare
to win” that is important. This will to prepare to
win is becoming an increasingly crucial factor inclinical trial execution.
The key stakeholders in the healthcare system(i.e., patients, providers, payers, and drug
developers) all benefit from a win in on-timeclinical trial execution. Patients receive quicker

Winning in patient recruitment means addressing

access to new treatments, providers and payers

these barriers and beating the time expected

gain innovative ways to meet their patients’to recruit the number of patients required toneeds, and drug developers achieve a successful

deliver a statistically meaningful result as well as

ROI for the risk taken by investors.

addressing other requirements of regulators inClinical trial execution involves several activities,

target countries.

including site setup, patient recruitment,

In some therapy areas, emerging treatments

monitoring, data quality management, and so on.

are curative, and the faster a sponsor completes

However, the most challenging aspect of on-time

the clinical trial, the faster it can gain access toclinical trial execution is patient recruitment.

existing patients in the market. Sponsors that

Therefore, to achieve clinical trial acceleration,

are second or third in that race may have a limited

clinical trial sponsors must prevail in patientpool of available patients, which may have very

recruitment.

negative consequences on their commercial

There are numerous reasons for slow patient

performance.

recruitment in clinical trials (see Figure 1).

Figure 1. Common reasons for slow patient recruitment inclinical trials
Figure 1. Common reasons for slow patient recruitment in clinical trials
CAUSES OF DELAYS AT TRIAL START-UP

CAUSES OF DELAYS DURING TRIAL CONDUCTPoor site selection

Non-optimized
sequence of site
activation

Overly optimistic
site-activation forecast

Competition withinclose geographic
proximityHigh screen failure& dropout rates

Managing misaligned
stakeholders

Health authority &review boards approval

Limited resources(esp. site staff)

Optimistic patientrecruitment targets

Lengthy screening
process

Slow response tosite roadblocks

Reactive KPI reporting

Prolonged contractingwith sites

Complex start-up tasks
happening in parallel

Inaccurate budget &resource estimates

Protocol deviations& amendments

Single-channel
outreach programsHigh staff turnover(e.g., clinical research
associates)

CRO = contract resource organization
Source: Arthur D. Little

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WHY THE GROWINGCHALLENGE ?
As more and more clinical trials are carried out
every year, in many cases from a limited poolof potential patients, recruiting patients in

R E C R U I T I N G PAT I E N T S
IN CLINICAL TRIALSIS BECOMINGI N C R E A S I N G LY
CHALLENGING

those clinical trials is becoming increasingly
challenging.
Several factors are responsible for the increasing

2. Patient screening. A patient may bechallenge in recruiting patients for clinical trials.

identified as a candidate for a trial, but patient

These reasons can be examined using the clinicalscreening may reveal that the individual does

trial patient treatment pathway as a guide,

not fulfill the requirements to be included.

including the five key steps in the pathway

In some cases, the patient may hesitate(see Figure 2):

to participate in the screening process if

1. Trial awareness. Patients are rarely awareof ongoing clinical trials and hence may
not proactively express an interest in
participation. They usually rely on physicians
for treatment-related information, and

it is burdensome. This process can be very
demanding and may be less appealing if there
are more acceptable treatment alternatives
available.
3. Treatment selection. Patients and theirdoctors may not always have clinical trials infamilies may hesitate to opt for a trial

the forefront of their minds as alternatives toeven if there is a potentially significant

propose to patients. Also, physicians may notbenefit. Clinical trial treatments carrybe aware of the occurrence of a trial. Language

the risk that any unapproved treatment

barriers are also a factor that may drive lack

carries, and patients may prefer to try anof awareness of trials by patients. In addition,

approved drug with known benefits and risks

social and cultural barriers as well as mistrust

over an experimental one, even when theof the medical system by some communities

experimental treatment may offer a higher

can impact the awareness of trials.

potential benefit. With the growing number
of approved treatment options available, thechallenge with trial treatment selection is

Figure 2. Challenges in patient recruitment
in clinicalexpected
to increase. trials

Figure 2. Challenges in patient recruitment in clinical trials
Clinical trial treatment pathway
1
Trial awareness

2

3

4

5

Patient screening

Treatment
selection

Treatment access

Trial dropout

Example:• General lack of awarenessof ongoing trials
Example:• Too strict protocol
eligibility criteria

Example:• Increased availability ofeffective treatment options
for patients

Example:• Challenges with persistence &compliance with the protocol

Example:• Challenges with access &cost of therapy coverage

Source: Arthur D. Little

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4. Treatment access. In some countries where
universal healthcare is not available, there
may be access and affordability restrictions
for those who may be ideal candidates forclinical trials. If a patient has no healthinsurance, for example, or the co-pay amountis high for certain treatments involving trials,
he or she may be unable to participate. Many

SPONSORS MUSTC A R E F U L LY C O N S I D E R
W H Y PAT I E N T S M AY
E I T H E R FA I L T O E N R O L L
OR CHOOSE TO DROPOUT OF TRIALS

trials are held in academic healthcare centers,
and some may be at a distance considered
too far by patients to commit to regular visits.
This is exacerbated by the increasing number

HOW TO WIN

of closures of trial sites in some established

While there have been many efforts to describe

clinical trial countries due to lack of financial

ways to accelerate clinical trials, many trial

viability, requiring patients to travel farther

sponsors struggle with the “how” question: howafield to access the trials. Furthermore,

do you speed up a clinical trial? Therefore, ourmany regulatory authorities require lifetime

focus in this Viewpoint is on how to prepare toaccess to the treatment for patients who

win using six effective steps in trial execution.

participated in the trial if the treatment is
successfully approved.
Trial sponsors that cannot afford these

1. Shift mindset from “patients as targets”
to “patients as partners”

requirements will avoid countries with

Many trial sponsors still see patients as targets tosuch requirements even if many potential

meet recruitment numbers rather than partners onpatients reside there.

the winning journey. When patients are considered

5. Trial dropout. Clinical trials usually require a
lot of visits to healthcare facilities, particularly
in non-decentralized trials. For patients who
have busy lives or may not have long to live,
it may be challenging to keep them in thetrials for a long time. Patients may, at somepoint, consider it more important to attend topressing domestic priorities or spend the brieftime they have left with loved ones rather thanmake recurring visits to a healthcare facility.

key partners, clinical trial sponsors will prioritize
patients’ needs and remove every obstacle toparticipating while using all possible means toincorporate their preferences throughout the trial
journey. While most major clinical trial sponsors
claim to be patient-centric, it is not uncommon
for the patient’s voice only to be heard just once atthe start of the trial. A shift in this mindset requires
continuous listening, review, and prioritization ofpatients’ needs throughout the trial journey.

This may lead to dropout.
To win with clinical trial execution, sponsors must
carefully consider why patients may either fail toenroll or choose to drop out of trials.

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The case study in Figures 3 and 4 illustrates anThis may include using generous financial

example where real-time insights helped increasemeasures to ensure the patient does notpatient recruitment. By mapping out a patient’s

suffer any loss — from covering the costs

journey and considering their personal costs andof transportation, child and pet care, patient

emotional response at each stage on an ongoingcompanions, and accommodation to providing

basis, sponsors can assess the patient’s needssome relief for working patients concerned

and treat them as their most important partner.

about loss of income due to participation.

Figure 3. Employing improved patient centricity to driveincreasedrecruitment — case study 1
Figure 3. Employing improved patient centricity to drive increased recruitment — case study 1
What wasthe situation
before theacceleration?

A US/EU phase III clinical trial for a novel therapy targeting a rare autoimmune disease of the central
nervous system (CNS) faced the risk of significant delays due to the COVID-19 pandemic.

What was thegoal of theacceleration?

The sponsor was concerned about potential recruitment delays, site closures, patient access limitations, etc.,
and wanted to deliver the trial on time despite outbreak of the pandemic.

What did
ADL do toaccelerate
the trial?

What was theresult of theacceleration?

ADL focused on making the trial more patient-centric by by reducing the perceived high patient burden of the trial.
There were also efforts made to reduce site burden. Patient-centric measures taken included setting up patientadvisory boards to understand patient needs, protocol amendment to minimize unnecessary visits and incorporate
virtual assessments when possible, and targeted support programs (e.g., childcare and travel). Site training wasprovided to support virtual assessments and enable patient safety with the new protocols.

Despite the pandemic, the trial was completed on time. Patient-retention rates exceeded initial targets andsite-satisfaction rates were very high. The focus on patient centricity proved to be the strategy for successin this rare indication that would have struggled to recruit patients during the pandemic.

Source: Arthur D. Little

Figure 4. Increased patient recruitment rates — case study 1
Figure 4. Increased patient recruitment rates — case study 1# of patients recruited

Source: Arthur D. Little

380
360
340
320
300
280
260
240
220
200
180
160
140
120
100
80
60
40
20
0

Recruitment delivered 3
months ahead of target
Recruitment target

Start of support of trialacceleration effort
Month 2Month 4Month 6

Month 8Month 10

Corporate recruitment timeline target

Month 12Month 14Month 16

Accelerated enrollment

Source: Arthur D. Little

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2. Avoid hearsay-driven decision-making

3. Encourage technophile mindset& follow data instead& deploy latest technology

In many trials, data sits idle while people makeTechnology changes quickly, providing morehearsay-based decisions. At every step in the trial

ways to win in clinical trial execution; forprocess — from concept to design and execution

example, AI-enabled solutions to rapidly review— there is siloed data that can be triangulated tolarge volumes of real-world data for patient

gain better insights and make smarter decisions.

matching, utilizing social media intelligence toThis may include combining external-to-trial-

find patient hotspots and prescreening patients,

sponsor data with very granular site-level data to

and applying graph networks to identify potential

make decisions related to a targeted engagement

pre-diagnosis patients. With the speed of newrather than using a standard approach across alltechnology introduction, we have seen several

sites. Predictive intelligence can speed up trial

cases where the solutions used in trial execution

execution if a connected data-driven approachnearly become obsolete in the time between

is pursued in answering the main exam questions.

trial design and trial close. Several use cases ofAcross all stages of the trial journey, there istechnology-enabled trial acceleration exist thatplenty of data available to improve decision-

show that technology deployment in clinical trials

making for those prepared to make the extra

can help gain execution speed even if it requires aeffort. Assessments at a granular level also

costly protocol amendment. Experience suggests

enable a sponsor to identify trends and goodthat clinical trial teams can be reluctant topractices to leverage across all relevant sites.

embrace recent technology. However, it takes a

As an example, Arthur D. Little (ADL) usedtechnophile mindset and a desire to continuously

traditional site start-up data with other data

search out and deploy these tools to enable(e.g., patient community sentiment, optimal

success in clinical trial execution.

diversity index, Google mobility data) to find someof the highest-performing sites on a rare disease
clinical trial (see Figure 5). This helped reduce trial
time by several months.

Figure 5. Accelerating recruitment with additional data
triangulation for high recruiting site identification
Figure 5. Accelerating recruitment with additional data triangulation for high recruiting site identification

Assessment ofplanned study
sites

Assessment ofqualifying
factors

Assessment ofcompetingpressure

Assessment ofsocial media
information

Validation with
key opinion
leaders

SSU metrics

Disease data

Vicinity analysis

Patient hotspots

Expert assessment• SSU milestones
cycle time vs.
benchmark• Epidemiology
data (regional)• Geolocation ofcompeting sites
within a reasonable
perimeter• Patient/topic
social media hot
spots vs. plannedsite locations• Predictionof impact ofcompeting sites
in same disease

Patient sentiment• Assessment ofstudy gaps &opportunities ofstudy execution(regional)

Site potential
metrics• Site feasibility vs.
adjusted feasibility
data• Site experiencein clinical trials
Historic studies
metrics• Recruitment rates,
screen failure
rates, etc.

Population density• Location
population &demographics
Healthcare
infrastructure• Disease diagnosis
infrastructure
at regional level• Referral systems
setup & impact

Drug availability• Impact of approved& accessible drugs• Impact of patientaccess programs• Patient community
sentiment on thesponsor & trial (inc.
competing studies)
Patient needs• Needs discussed
online about theway sites aretreating patientsDiversity
assessment• Qualification of
the diversity plan
provisions(regional level) by
diversity
representatives

Resulting solution is tangible &provides scoring of sites by
probability of patient recruitment
success

Blue = external to most trial sponsors

SSU = site start up
Source: Arthur D. Little

SSU = site start up

Source: ArthurCURES
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4. Know competing trial protocols

5. Anticipate risks & opportunities using

better than your own

leading indicators; take prompt action

Successful sales representatives are well-versed

Many clinical trial teams watch helplessly as

in identifying the strengths and weaknesses of

the trial goes through a protracted and agonizing

competing offerings and know how to position

struggle to take off. They rely on outdated

the value of their offerings to meet customer

information or lagging indicators to makeneeds. Applying this mindset in clinical trials

decisions and cannot anticipate challenges

can enable trial sponsors to prevail. It is important

before they become serious. Leading indicators

to first understand the challenge that the

can help anticipate risk and support winning

active drug in your clinical trial addresses in theclinical trial teams to seize emerging patient-treatment landscape and then contrast this withrecruitment opportunities. In a global phasecompeting offerings in clear communications by

III trial, ADL designed a “one-source-of-truth

all roles with contact of patient-access groups,

leading indicator dashboard” to predict andprincipal investigators, and other stakeholders.

anticipate risk (see Figures 7 and 8). In the

It is also vital to have a deep understanding of the

post-trial review, the sponsor considered thesite and patient offerings provided by competing

dashboard as the highest contributor to the earlytrials and strive to match or outperform thosecompletion of patient recruitment in the trial.

offerings. Figure 6 illustrates the potential of

Achieving the benefit required the connection

using competition to increase recruitment.

of data from various data sources, applying the
key risk/opportunity indicator methodology, andmaking the intelligence available to all trial teammembers, including the supporting contract
research organization and other vendors.

Figure 6. Harnessing the power of competition to driveincreasedrecruitment— casestudy
2 recruitment — case study 2
Figure 6. Harnessing
the power of competition
to driveincreased
What wasthe situation
before theacceleration?

What was thegoal of theacceleration?

A global phase III hematology trial faced recruitment delays, particularly in regions with multiple, colocatedcompeting trials. Traditional perception viewed such competition as negative for recruitment speed.

The trial sponsor wanted to claw back time lost to delayed recruitment.

What did
ADL do toaccelerate
the trial?

In-depth analysis showed that recruitment was stronger in areas within a certain geolocational range withstiff competition as sites were optimizing their strategies, becoming more efficient, and sharing knowledge.
In response to this insight, we invested in sites with “optimal” competition levels and provided targeted support
in the form of facilitation of collaboration between sites and sharing best practice.

What was theresult of theacceleration?

As a result of the intervention, there was a significant reduction in recruitment delays, and overall trial timelines
were accelerated, meeting the trial target deadlines. This case challenged the assumption that increased competition
between clinical trial sites hinders progress. In this trial, competition acted as a catalyst for enhanced performance,
highlighting the potential benefits of leveraging a competitive environment through targeted support, collaboration,and strategic engagement.

Source: Arthur D. Little

Source: Arthur D. Little
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6. Establish senior management sponsorshipTo win in clinical trial execution, a dedicatedfocus must exist at very senior levels in theorganization, and all available resources must
be employed to remove barriers and drive
acceleration. Unfortunately, many senior leaders
are too distanced from the realities on the

UNISON BETWEEN
THE “DOERS” AND
THE BUSINESS LEADERSIN ADDRESSING
CHALLENGES WILLC ATA LY Z E A C C E L E R AT I O Nground, relying on monthly progress reports orbudget requests to understand the situation
with their clinical trials. While it is not possible
for senior leaders to examine all clinical trials, it
is important that they dedicate attention to theclinical trials that are vital to the future of thecompany. For the things that really matter andthe lifeline of any company, unison between the“doers” and the business leaders in addressing
challenges will catalyze acceleration. Conversely,
insufficient senior leadership involvement will
adversely impact the study and the team’s ability
to win.

Figure 7. Leveraging real-time insights and predictive
analysis
to increase recruitment — case study 3
Figure 7. Leveraging real-time insights and predictive analysis to increase recruitment — case study 3
What wasthe situation
before theacceleration?

A phase III clinical trial for a rare disease was projected to be over 1 year behind schedule, jeopardizing potential
approval and patient access. Patient recruitment was particularly challenging on the program.

What was thegoal of theacceleration?

The goal was to enable the trial to minimize the risk of the projected delays and achieve close to the originalcompletion target date.

What did
ADL do toaccelerate
the trial?

We built a “success leading indicator” dashboard, among other interventions, that tracked and visualized multiple
leading indicators of risks and opportunities and enabled the following:• Improved visibility. The dashboard provided real-time insights, enabling proactive intervention and addressing
bottlenecks early.
• Predictive analysis. Leading indicators allowed for proactive risk mitigation and course correction.
• Targeted intervention. Data-driven insights helped the team prioritize resources and implement targeted
solutions at critical points.
• Enhanced collaboration. This resulted in increased transparency and facilitated communication between
stakeholders, including external vendors.

What was theresult of theacceleration?

The trial was completed on time, delivering critical data for approval and accelerating potential access for patients.
The success leading indicator dashboard with predictive actioning was identified as the #1 accelerator inenabling turnaround in patient recruitment. This case demonstrates the power of real-time data, transparency,
and collaboration in optimizing clinical trial operations, particularly for rare diseases with tight timelines andlimited resources.

Source: Arthur D. Little

Source: Arthur D. Little

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9ure 8. Patient recruitment acceleration — case study 3
ARTHUR D. LITTLE

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Figure 8. Patient recruitment acceleration — case study 3

Actual recruitment

180# of patients recruited

160

Recruitment target

Completed aheadof competing trial

140

120

Start of supportof trial-acceleration
effort

100

80

60

40

20

+14 months of delay
without acceleration

Very low
recruitment
rates~$1.5 bn loss
projected (sunk &opportunity costs)

0

Jan

Jun
Year 1

Jan

Dec
Year 2

Source: Arthur D. Little

Arthur D. Little

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CONCLUSIONWINNING IN CLINICAL TRIALS:D O Y O U H AV E W H AT I T TA K E S ?

B Y W I N N I N G I N O N -T I M E C L I N I C A L T R I A L
E X E C U T I O N , T H E E N T I R E H E A LT H C A R E
SYSTEM BENEFITS

Winning in clinical trial execution is beneficial to all key stakeholders,
as it enables sponsors to maximize the rewards from years of investingtime, money, and know-how. Furthermore, with the increasing shift tocurative therapies, second and third movers to launch may find they havefar fewer patients to treat in the future. Yet, even with a will to win, manysponsors struggle as challenges prevent seamless patient recruitment.
It thus falls to sponsors that have the will to prepare to win to be boldand shift the mindset to see patients as partners, following the data
in making decisions, using the latest technology to maximum effect,knowing competitor protocols better than yours, anticipating danger
using leading indicators coupled with quick action, and devoting seniorleadership attention to trial acceleration.
By winning in on-time clinical trial execution, the entire healthcare
system benefits, giving patients better access to treatments,
providers and payers a better opportunity to meet their patients’needs, and pharma/biotech companies receive a higher ROI. Withclinical trial execution, winning does not come to those who wait.

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