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How to Overcome Patient Recruitment Roadblocks
1000 Park Forty Plaza, Suite 440 Durham, NC 27713 www.cuttingedgeinfo.com
Presented by: Ryan McGuire & Elio Evangelista
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Europe & EU
15%
Asia & Middle
East6%
Africa2%South
America2%
Oceania2%
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Related Studies
Clinical Trial Patient Recruitment:Accelerate Enrollment,
Increase Retention and Reduce Costs
Optimizing Clinical Pharmacology
Programs:Cost-Drivers of Phase I Trials
Oncology Clinical Trials:
Drug Development Resources and Case Studies
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Goals of Cutting Edge Information’s Patient Recruitment Research
• Address the challenges associated with patient recruitment with best practices and recommendations.
• Identify the pitfalls in clinical trial planning that lead to poor patient recruitment.
• Provide insights on patient motivators that attract patients to clinical studies.
• Help companies create a patient recruitment process. Many companies don’t and subsequently fail to get patients for their trials.
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Webinar Agenda
Patient
Retention
1) Dedicate PR Budget
2) Patient Research
3) Site Selection
4) Identify PatientMotivators
SuccessfulClinical
Trial
Round 1
Round 2
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Factor Most Responsible for Increased Clinical Trial Costs
2%
7%8%
12%
14%
25%
32%
Patient retention
Data cleaning,statistical analysis,report writingSite retention
Technology (EDC,patient diaries, datamgmt., etc.)Site recruitment
Vendor fees
Patient recruitment
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Recruitment Delays in Clinical Trials
11%
18%
16%
10%
17%
9%
16%
11%
15%
0% 10% 20% 30% 40% 50%
Phase 1
Phase 2
Phase 3
Final Protocol to FPI FPI to 50% 50% to LPI
+16%
Percentage increase intotal duration across all trials.
Increase in Trial DurationCopyright Cutting Edge Information
#1 Seed: Set a Patient Recruitment Budget
• There are few adequate plans to deal with patient recruitment challenges.
• There is too much faith that patients will flock to the clinical trial.
• The typical budget allocated for patient recruitment is 1% to 15% of the total trial budget.
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7%
15%
9%
6%
8%
0%
2%
4%
6%
8%
10%
12%
14%
16%
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
Average Patient Recruitment Budget Allocation by Phase (Sponsors/CROs)
Development Phase
Perc
enta
ge o
f Bud
get
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Trial-Wide Patient Recruitment Budgets by Phase
$110
$898
$2,709
$1,118
$78.6 $0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
Development Phase
Bud
get (
in T
hous
ands
)
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Site-Level Patient Recruitment Budgets by Phase
$84
$6.6 $1.8
$5.8 N/A
$0
$10
$20
$30
$40
$50
$60
$70
$80
$90
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
Development Phase
Bud
get (
in T
hous
ands
)
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#2 Seed: Research Patients to Improve Recruitment
Use patient demographic research to answer these important questions about the patients needed for your trial:
Where is this disease most common?
Is the disease prevalent in certain ages/genders?
Are there any socio-economic characteristics associated with the disease?
Where can I find treatment-naïve patients?
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Percentage of Participants that Rely on Key Stakeholders to Conduct Patient Demographic/Population Research
20%
3%
30%
4%
16%
28%
0%
5%
10%
15%
20%
25%
30%
35%
CRO CRO-hiredVendor
Sponsor Sponsor-hiredVendor
Trial Site Staff Did NotPerform
n=16 n=2 n=24 n=3 n=13 n=22
Company Type
Perc
enta
ge o
f Par
ticip
ants
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4.5
7.77.0 6.9
3.5
6.8
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4 Average
n=6 n=15 n=20 n=13 n=2 n=56
Effectiveness Ratings of Conducting Patient Demographic/Population Research by Phase
Development Phase
Inef
fect
ive
Very
Ef
fect
ive
Som
ewha
t Ef
fect
ive
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Know Thy Patient: Leverage Patient Advocacy Groups to Find Potential Patients
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Percentage of Participants that Rely on Key Stakeholders to Work with Advocacy Groups
Company Type
16%
5%
57%
9%
1%
12%
0%
10%
20%
30%
40%
50%
60%
CRO CRO-hiredVendor
Sponsor Sponsor-hiredVendor
Trial Site Staff Did NotPerform
n=12 n=4 n=43 n=7 n=1 n=9
Perc
enta
ge o
f Par
ticip
ants
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6.3
5.4 5.2
6.3
5.05.7
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4 Average
n=4 n=7 n=9 n=7 n=2 n=29
Effectiveness Ratings of Working with Advocacy Groups by Phase
Development Phase
Inef
fect
ive
Very
Ef
fect
ive
Som
ewha
t Ef
fect
ive
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#3 Seed: Evaluate Potential Sites and Investigators to Improve Patient Recruitment
• A comprehensive examination of the physical space and the site’s patient population is crucial to meeting recruitment goals
• Site selection ranked as the most-effective patient recruitment tool among surveyed companies.
• When possible, choosing sites that rely on electronic medical records aids the patient recruitment process immensely.
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Electronic Medical Records in Action
“We first looked at how many patients were identified in the site’s EMR system. Then, part of our recruitment plan was to reach out to them specifically through letters and postcards. For this particular study, because we were doing such a focused effort, we called every single person to meet our recruitment goals.”
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Average Number of Sites for Oncology Trials by Phase
5.0
43.1
106.0
0
20
40
60
80
100
120
Phase 1 Phase 2 Phase 3
Num
ber o
f Site
s
Development PhaseCopyright Cutting Edge Information
Patie
nts
Per S
ite
n=26
Range and Average Number of Patients Per Site in Oncology Trials by Phase
0
5
10
15
20
25
30
35
40
Phase 1 Phase 2 Phase 3
12.9
3.45.1
Development PhaseCopyright Cutting Edge Information
#4 Seed: Tap Into Patient Motivators To Speed Up The Patient Recruitment Process
• The biggest patient motivator is altruism. Patients want to give back.
• To benefit from patient altruism, companies should incorporate altruistic language in the clinical trial’s marketing efforts.
• Among other motivating factors, the prospect of improved treatment for the patient’s disease is the most effective.
• Other key motivating factors include site and protocol convenience.
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Patient Motivators
Patients’ Emotions
The most effective patient motivators blend emotional aspects of clinical trials with convenience.
Trial Convenience
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Effectiveness Rating
Patie
nt M
otiv
ator
Overall Effectiveness of Patient Motivators
4.6
4.9
5.6
5.7
6.6
6.8
7.3
7.9
0.0 5.0 10.0
Non-monetary incentives
Monetary compensation
Transportation Compensation
Short trial duration
Number/frequency of site visits
Prospect of receiving free medication
Convenience of sites
Prospect of improved treatment
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6.9
8.57.8 7.6
8.77.9
6.67.6 7.8
6.4
7.7 7.3
0123456789
10
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4 Overall
Prospect of Improved Treatment Convenience of Sites
Development Phasen=77
Effectiveness Ratings of Patient Motivators by PhaseIn
effe
ctiv
eVe
ry
Effe
ctiv
eSo
mew
hat
Effe
ctiv
e
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Development Phasen=28
Range and Average Trial Duration, by Phase
0
10
20
30
40
50
60
70
80
90
Phase 1 Phase 2 Phase 3
Dura
tion
(in M
onth
s)
27.5 26.1
41.3
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Never Underestimate Altruism
“Patients still want to participate by and large for the altruistic reasons of helping society and helping to further the understanding of their disease. I think when you look at surveys that have been done, people will say by and large it’s altruism that drives them to want to participate.”
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Round 2: Patient Retention Strategies are Underused by the Healthcare Industry
• Patient dropout rates can run as high as 30%, but only half of the surveyed companies have patient retention strategies in place.
• Too often, drug companies rely on their CROs to manage patient retention rather than developing plans themselves.
• Despite having more resources to develop patient retention strategies, large pharma companies are the least like to do so.
• The data show that the most used patient retention strategies are phone call reminders, treatment follow-up by phone, transportation assistance and print/paper support materials.
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Percentage of Participants that Use Patient Retention Strategies by Company Type
36%50%
67%
38%17%
67%50%
64%50%
33%
62%83%
33%50%
0%10%20%30%40%50%60%70%80%90%
100%
LargePharma
Mid-sizePharma
SmallPharma
Biotech Device/Diagnostic
CRO Overall
n=11 n=4 n=3 n=13 n=6 n=27 n=82
Utilize Patient Retention Strategies Do NOT Use Patient Retention Strategies
Company Type
Perc
enta
ge o
f Com
pani
es
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Percentage of Participants Using Patient Retention Strategies by Phase: Visit Reminders by Phone
Development Phase
Perc
enta
ge o
f Par
ticip
ants
50%
100%85%
75%
50%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
n=4 n=10 n=13 n=12 n=2
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Percentage of Participants Using Patient Retention Strategies by Phase: Visit Reminders by Email
Development Phase
Perc
enta
ge o
f Par
ticip
ants
50%
30% 31%
17%
0%0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
n=4 n=10 n=13 n=12 n=2
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Percentage of Participants Using Patient Retention Strategies by Phase: Print/Paper Patient Support Materials
Development Phase
50% 50%46%
58%
100%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
n=4 n=10 n=13 n=12 n=2
Perc
enta
ge o
f Par
ticip
ants
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Percentage of Participants Using Patient Retention Strategies by Phase: Treatment Follow-up by Phone
Development Phase
Perc
enta
ge o
f Par
ticip
ants
75%
60%
46%42%
100%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
n=4 n=10 n=13 n=12 n=2
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Percentage of Participants Using Patient Retention Strategies by Phase: Transportation Assistance
Development Phase
75%
30%
54%58%
100%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Phase 1 Phase 2 Phase 3a Phase 3b Phase 4
n=4 n=10 n=13 n=12 n=2
Perc
enta
ge o
f Par
ticip
ants
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1000 Park Forty Plaza, Suite 440Durham, NC 27713www.cuttingedgeinfo.com
Presented by:Ryan McGuireResearch Team LeaderCutting Edge [email protected]. +1 919.433.0382
How to Overcome Patient Recruitment Roadblocks
Moderated by:Elio EvangelistaDirector of ResearchCutting Edge [email protected]. +1 919.433.0214