how to overcome patient recruitment roadblocks...how to overcome patient recruitment roadblocks 1000...

How to Overcome Patient Recruitment Roadblocks

1000 Park Forty Plaza, Suite 440 Durham, NC 27713 www.cuttingedgeinfo.com

Presented by: Ryan McGuire & Elio Evangelista

About Cutting Edge Information

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North America

73%

Europe & EU

15%

Asia & Middle

East6%

Africa2%South

America2%

Oceania2%

Copyright Cutting Edge Information

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


http://www.cuttingedgeinfo.com/research/clinical-development/patient-recruitment/

http://www.cuttingedgeinfo.com/research/clinical-development/clinical-pharmacology/

http://www.cuttingedgeinfo.com/research/clinical-development/oncology-clinical-trials/

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.


Webinar Agenda

Patient

Retention

1) Dedicate PR Budget

2) Patient Research

3) Site Selection

4) Identify PatientMotivators

SuccessfulClinical

Trial

Round 1

Round 2


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


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.


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


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


Development Phase

Bud

get (

in T

hous

ands

)


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


Development Phase

Bud

get (

in T

hous

ands

)


#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?


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


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


Know Thy Patient: Leverage Patient Advocacy Groups to Find Potential Patients


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


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


#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.


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.”


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


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.


Patient Motivators

Patients’ Emotions

The most effective patient motivators blend emotional aspects of clinical trials with convenience.

Trial Convenience


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


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


Development Phasen=28

Range and Average Trial Duration, by Phase

0

10

20

30

40

50

60

70

80

90


Dura

tion

(in M

onth

s)

27.5 26.1

41.3


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.”


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.


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


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%


n=4 n=10 n=13 n=12 n=2


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%


n=4 n=10 n=13 n=12 n=2


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%


n=4 n=10 n=13 n=12 n=2

Perc

enta

ge o

f Par

ticip

ants


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%


n=4 n=10 n=13 n=12 n=2


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%


n=4 n=10 n=13 n=12 n=2

Perc

enta

ge o

f Par

ticip

ants


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

how to overcome patient recruitment roadblocks...how to overcome patient recruitment roadblocks 1000...

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