Use CaseTrial Recruitment
at Warp Speed
How Citeline Connect Supported theFastest-recruiting COVID-19 Clinical Trialin Operation Warp Speed History

July 2023

Use Case | Trial Recruitment at Warp Speed

Recruiting with Scale, Speed and Diversity
A late-stage biotechnology company developing a next-generation vaccine against
COVID-19 was set to conduct a large Phase III trial. The trial design was aligned with other
Phase III trials conducted under the auspices of Operation Warp Speed, and planned withspecific recruitment diversity goals and an enrollment target of 30,000 volunteers. Locationof trial sites emphasized communities and demographic groups most impacted by thedisease, including people over age 65 and those living with comorbid conditions that placed
them at higher risk of complications from COVID-19.

“The full enrollment of [this trial] is another important step in building
a body of evidence to demonstrate that [the vaccine] will be safe andeffective across diverse, representative populations.”
PRESIDENT, RESEARCH AND DEVELOPMENT
COVID-19 TRIAL SPONSOR

ENROLLMENT GOALS AT LAUNCH:≥ 25%of the study population
65 years of age or olderBlack/African-American

10-25%

1-2%

LatinX2≥ 15%

July 2023 American Indian

Copyright ©️ 2023 Citeline, a Norstella company. (Unauthorized photocopying prohibited).

Use Case | Trial Recruitment at Warp Speed

Citeline Connect Selected
Operation Warp Speed partners who had previously succeeded in recruiting for a highprofile Phase III COVID-19 trial with Citeline Connect introduced the solution to the study
sponsor’s CRO. Citeline Connect was selected to support the trial’s 30,000-participant goal.
The sponsor was now able to work with many of the same recruiting partners that hadalready responded to its RFP, simultaneously and without the burden and risk associatedwith selecting just one.
Within just days of launch, 20 recruitment partners across a variety of specializations andrecruiting methodologies — each armed with IRB-approved assets co-created by theCiteline Connect team — mobilized to instantly begin referring patients to enrolling researchsites at once.

SOME OF THE RECRUITMENTPARTNERS WHO ACTIVATED
SomeTHISof theTRIAL
recruitment partners
FOR
who activated for this trial

Copyright © 2021 Informa PLC
3July 2023 Copyright ©️ 2023 Citeline, a Norstella company. (Unauthorized photocopying prohibited).

Use Case | Trial Recruitment at Warp Speed

Reinventing
Reinventingthe
theRecruitment
RecruitmentModel
Model
Unlike traditional clinical trial recruitment models, Citeline Connect works as a collective,
empowering over 100 different recruitment partners to refer patients to research sites
Unlike traditional clinical trial recruitment models, Citeline Connect works as a collective, empowering up to 75
concurrently
using a pay-for-performance model. In this specific trial, recruiters weredifferent recruitment partners to refer patients to research sites concurrently using a pay-for-performance model.
compensatedforrecruiters
both referrals
and randomizations,a predetermined
rate card
In this specific trial,
were compensatedfor both referralsthroughand randomizations,through a predetermined
rate cardupon
agreedbyupon
the sponsor
andCRO.
CRO. Thismodel incentivizedrecruiters to directly
agreedthebysponsor
andThispay-for-performancepay-for-performancemodel incentivized
optimize theirperformance.
recruiters
tooutreachdirectlyand
optimize
their outreach and performance.

Traditional
Traditional
Recruitment
RecruitmentProcess
Process

Recruitment ofofthe
theFuture
FutureRecruitment

Sponsoror CRO
Sponsor or CRO

Sponsor or CRO
Sponsor or CRO

OROROROR

Recruitment Recruitment
Recruitment
Recruitment
partnerpartnerpartner
1 1partner
2 2

Recruitment
Recruitment
partner3 3partner

CentralizedRecruiting
RecruitingCollective
Collective
Centralized

Recruitment
Recruitment
partner 1
partner

PaidforEffort
EffortPaidforRecruitment
Recruitment
partnerpartner22

Recruitment
Recruitment
partnerpartner3 3

Recruitment
Recruitment
partner
4 4partner++++++

Paid
PaidforforPerformance
Performance

Centralizing
Centralizing
IRB-Approved Assets
IRB-ApprovedAssets
Citeline Connect’s built-in content repository was used
to provide all recruitment partners with the same IRBCiteline Connect’scontent repository
was emailused toandprovideapproved
copybuilt-inand imagery,including
callallrecruitment partners with the same IRB-approved copy and imagery,centerscripts.
Sampleadvertisements
were also createdincludingemail andcall center
scripts. Sample advertisements
were also
toensureproperuseofrecruiting
materials
acrosscreated to ensure proper use of recruiting materials acrosssocialsocial
channels suchas Facebook,
Twitter Twitterand Instagram.
channelssuchas Facebook,and Instagram.
44

July 2023 Copyrightphotocopying© 2021 Informa
PLC
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Use Case | Trial Recruitment at Warp Speed

SettingSites Up
Up forfor Success
Success
Setting Sites
In a study such as this one, with a large volume of prospective participants and accelerated
startup timelines, creating processes to prevent catastrophic site congestion andstreamlining
theprocess
throughtechnology
werekeyto success.
First,a TrialIna study such as
thisenrollment
one, with a large
volumeof prospective
participantsandaccelerated
startuptimelines,
creatingprocesses
topreventcatastrophic
site
congestion
andstreamlining
theenrollment
process
throughSite Administration portal was established to allow local site staff to edit and confirm thetechnology
were keydetails
to success.
Site Administration
was established
to allow
local
site
staff tocorrect contact
forFirst,
theira Trial
locationsand, mostportal
importantly,
changetheirsite
recruiting
edit and confirm the correct contact details for their locations and, most importantly, change their site recruiting
statusreal
as neededpauseduringreferrals
status inin
realtimetime
as needed
to pausetoreferralsbusy duringspurts. busy spurts.
Theadministration
portalalso allowed
thesponsor
andremove
The administration
portalalso allowed
the sponsor
andCRO teams
to CRO
add orteams
removetositeadd
stafforusers
and oversee
site staff
users inandoverseesite-levelInanalytics
a single
webapplication.
In thecaseof
site-level
analytics
a single
web application.
the case ofin
individual
sites
becoming
bogged downwithreferraltraffic,
adminscould
re-route
referrals
to
other
local
sites
toeasecongestion
andensurenoleads
wereleftbehind.
individual sites becoming bogged down with referral traffic, admins could re-route referrals
to other local sites to ease congestion and ensure no leads were left behind.

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Copyright © 2021 Informa PLC

Use Case | Trial Recruitment at Warp Speed

Setting Sites Up for Success (Continued)

Setting Sites Up for Success continued
Setting Sites Up for Success (Continued)
Second, Citeline Connect created and launched new

Second, Citeline Connect created and launched new capabilitiescapabilities
totelephone
this trial:support
A toll-free
telephoneuniqueto this trial:unique
A toll-freeauto-attendantsupportauto-attendantandanautomatedand an automated email responder for inbound inquiries.email
responder
forinboundinquiries.
Working
togetherWorking
togetherto Connect
alleviateparticipant
andrespond
toto
Second,Citelinecreatedandconcerns
launched
newcapabilities
commonquestions,thesetechnologies
bufferedpatient
inquiries
alleviateparticipant
concerns
andrespondtocommon
unique to this trial: A toll-free telephone support auto-attendant
fromquestions,reachingsite
personnel,
while ensuring
most pertinent
andan automatedemail
responder
forinboundinquiries.
these
technologies
bufferedpatientquestions
wereaddressed.
Working together
to alleviatesite
participant
concerns
andensuring
respond toinquiries
from reaching
personnel,
whilecommonquestions,thesetechnologies
bufferedpatient
inquiries
most pertinent questions were addressed.
fromreaching
personnel,
while trial
ensuring
most pertinent
Lastly,ratherthan siteallowing
prospective
participants
toquestions
were addressed.
contactsites independently,
Citeline Connect’s embedded
Lastly, rather
thanallowingacrossprospective
trial
prescreening
solution
was deployed
all recruitment
participants
tocontactsites
independently,
Citeline
partners,
the allowing
sponsor’s
own trial website,
to quickly
Lastly,including
rather thanprospective
trial participantstoConnect’sprescreening
solutionwasprequalify
This prevented
moreConnect’s
than 130,000
contactpatients.
sites embedded
independently,
Citeline
embeddedunqualified
referrals
fromcontacting
alreadybusysites.
deployedacrossallwasrecruitment
partners,
includingprescreening
solution
deployedacrossall recruitment
partners,
includingthe trialsponsor’sown trial
website, prequalify
to quickly
thesponsor’sown
website,to quickly
prequalify patients.
This prevented
130,000
patients.
This prevented
moremorethanthan
130,000
unqualified
unqualified
referrals
fromcontacting
alreadybusy
sites.
referrals from contacting already busy sites.

66July 2023 “Yourcampaign
has been“Yourcampaign
extremely successful
hasbeen extremely
for us! We are receiving“Yourcampaign
has been
successful
forus!
Wemany[CitelineConnect]
extremely
successfulreferrals
which havemany
been
are receiving
forwonderful!”
us! We are receiving[CitelineConnect]
many [CitelineConnect]referrals
which
have
been
SITE DIRECTOR
referrals
which
havewonderful!”
been wonderful!”
DIRECTORSITESITE
DIRECTOR

Copyright ©️ 2023 Citeline, a Norstella company. (Unauthorized photocopying prohibited).

Copyright © 2021 Informa PLC

Use Case | Trial Recruitment at Warp Speed

Channel and Campaign Analytics
Channel and Campaign Analytics
Through Citeline Connect, the sponsor
Citeline
Connect,andThroughCRO teams
were able
to review
recruiter-specificthe sponsorperformanceand CRO metrics
suchas prescreened
patients
teamswere able
to andnumber of participants randomized,
review recruiter-specificas well as campaign-specific details
metrics
for performance
their own advertisingacross socialsuchasprescreened
media channels such as Facebook.
andisnumberof byThispatients
level of detailmade possible
Citeline
Connect’s technology
coupledparticipants
randomized,
withasdaily
IRTreports
ingestedwell as campaign- into
the platform.

specific details for theirown advertising acrosssocial media channels suchas Facebook. This level ofdetail is made possible
by Citeline Connect’stechnology coupled withdaily IRT reports ingested
into the platform.

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Use Case | Trial Recruitment at Warp Speed

Achieving the Enrollment Goal in Record Time
Citeline Connect delivered 6,432
randomizations (22% of target), over 50%
within the minority population, in a recordsetting 48 days — reaching the enrollment
goal 55% faster than the next quickest
Operation Warp Speed clinical trial.

“Working with [Citeline Connect]
on this study has been a pleasureand very successful. It has turned
out to be money well spent.”
DIRECTOR, CLINICAL OPERATIONSCOVID-19 TRIAL SPONSOR

215,778
PreScreened

39%

85,634
Referred

Randomized

8July 2023 

8%

6,432

Copyright ©️ 2023 Citeline, a Norstella company. (Unauthorized photocopying prohibited).

Use Case | Trial Recruitment at Warp Speed

Connect. Refer. Screen. Enroll.
Only Citeline Connect can help you rapidly find, refer and screen highly
qualified patients for even the most challenging clinical trial.
Broaden Your Recruitment Funnel
Reach millions of patients from over 75 diverse data partners

Improve Referral Quality
Incorporate patient qualification earlier in your process

Pay for Performance
Set fees using an intelligent pricing recommendation engine

Optimize in Real Time
Gain confidence with analytics on all referral channels

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