Patient Attitudinal Research

Regarding Study Participation

What have we learned and

how can it help us enroll and

keep patients

John Needham

PatientQuest

Learning Objectives

• Assess aggregated results from recent patient

surveys:

– What do patients think about trials

– Where are they getting information about trials

– What are their perceived barriers to joining

– How has their disease affected their life and the

relationship with their family

– What are they expecting from the site in the way of

retention efforts

– How far are they willing to travel

• How these answers different outside the US

• How we use this insight to better approach patients

A Patient-Centered Mindset….

• Is more about how patients think or what

they feel or how they see themselves and

their disease rather than what they normally

do

• Especially important in high-involvement

decisions (e.g. finances, automotive, family

matters, health)

• Explores complex motivations and needs

• Predicts behavior

Deficit Needs

Being Needs

Maslow’s Hierarchy of Needs

Patient Attitudinal Research

Oncology

USA: Moffit, Sloan Kettering, Fox Chase

N= 200 participants

January 2011

Newly Diagnosed Oncology

Patients

• Most looking for “hope” and second opinion. Majority are diagnosed and begin treatment elsewhere; not treatment naive

• Do not know what a clinical trial is: – It’s what they do after the regular drug doesn’t work

• Hope they are not offered one so they don’t have to deal with those decisions – I don’t want to be a guinea pig

• Would participate if MD suggested – if the Dr. tells me to do it, I will

Currently Treated Patients

• Don’t understand purpose of trials

– “Trials are what they do when they don’t know what to

do with you? Standard treatment is best”

– “I thought that was for rare diseases? I have regular

old lung cancer.”

• Equate trials with experimentation

– “I don’t want anything that hasn’t been tested.”

– “Why should I waste the time I have left so somebody

can monkey around with a new idea?”

Patients who did not

participate in a Clinical Trial

• Being offered a trial means my condition is hopeless

• “Thank goodness I didn’t get offered a trial, that means there is still hope for me.”

• Skeptical of science and scientific procedures

• “Trials are for guinea pigs or the elderly who don’t have much time left anyway”

• “I wouldn’t want to get a placebo and they do that to you without you knowing that.”

Patient Attitudinal Research

Bipolar Depression

USA, Colombia, India, RSA, Czech Republic, Russia,

Ukraine

N= 320 participants

April 2011

34%

34%

32%

Do you feel that your Doctor understands your condition or

mood swings?

a. Not as concerned as I would like

b. Yes

c. No

39%

61%

Has the doctor ever used the term "bi-polar" or "manic

depression" to describe your mood swings?

a. Yes

b. No

37%

63%

a. Yes b. No

Do you feel that you have received enough information from your Doctor, clinic, support group or the internet to help you manage your mood swings?

60%

40%

0%

10%

20%

30%

40%

50%

60%

70%

a. Yes b. No

Are you looking for new treatment options or different medications which may perform better than

your current prescription?

36%

10% 11%

4%

26%

12%

a. My job b. School schedule c. Embarrassment about my condition

d. Bad weather for traveling to the

doctor

e. Some days I can not leave the

house, too depressed

f. Pressure from my family or friends about

being in a research study

What might be a challenge for you when considering participation in a study with 8 appointments scheduled

over 10 weeks?

12%

2% 4% 4%

6%

18%

11%

3%

21%

3% 3% 3%

8%

2%

Where would be a good place to put the messages about our research study? (pick 2)

72%

28%

Do you look for advice on your mood swings on the internet?

a. Yes b. No

CareforPE

Attitudinal Research Insights

420 responses in <1 week

10 countries OUS

10% enrollment after 90% of time

Agency never tested message

Untested Image: Effective?

Countries:

Austria

Belgium

France

Germany

Italy

NL

Spain

Sweden

UK

Bulgaria

Czech Rep

Hungary

Poland

Romania

Male Summary

• 78% experience with every partner

• Poland, Hungary responders youngest; Italy, US,

UK oldest

• 84% have never tried OTC products

• Emotions:

– Embarrassed

– Insecure

– Disappointed

– Anxious

– Frustrated

– Let down

– Angry

Female Summary

• Mixed results in comfort level talking about intimate details during a trial question

– Yes UK, Italy, Poland

– No Germany, Netherlands, Hungary

• 72% do not help partner with PE

• Married 47%, living together 10%, not living together but monogamous 37% (varies)

• Emotions: disappointed, depressed, irritated, embarrassed, frustrated

Clarity Gained

• Opioid concern ~ 1/3 Yes vs. 2/3 No

• 2/3 of men feel they will not outgrow PE

• 2/3 seek info on the internet

• 10% of males tell friends; 40% of women do

• Italy, Hungary, Romania most hits: > 50 in 1 day

• Sweden, France, Czech Republic: single digits

Uncertainties

• Pharmacotherapy ~ 50/50

• 33% of males unwilling to speak with MD

• ~ 50% talk with partner; 28% partners try to help

• <10% have been in a trial

• Is this condition sufficiently urgent to join a study:

12% male and 23% female say PE strains their

relationship

Looking Forward

• Target: >40 & married

• First time help seeker, not too afraid to talk

• Need open minded female partner; more common

in major cities/ liberal minded

• Messages: help each other, increase positive

experience, decrease anxiety and sexual

frustration

Surprise! Failed Image: why?

PDNP Patient Survey Results

www.carefortinglingfeet.com

N=712

24%

16%

14%

13%

23%

10%

I would describe my pain as: (Check all that apply.)

a. Pins and needles

b. Stabbing/shooting

c. Burning

d. Aching/throbbing

e. Numb

f. Sharp

11%

27%

17%

25%

19%

a. Mild b. Comes and goes

c. Sometimes bad

d. Mostly bad at night

e. Always bad

How would you describe your pain?

13%

3%

11%

20%

44%

4% 5%

What kind of doctor specialty do you consult for your pain?

a. Neurologist

b. Pain physician

c. Endocrinologist

d. Diabetologist

e. General Medicine/Family Practitioner

f. Podiatrist

g. Other, please specify:

a. Not as much as I would like

b. Yes c. No

54%

28%

18%

Do you feel that your Doctor understands your level of pain and how it is affecting your quality of life?

a. Yes b. No

24%

76%

Do you feel that you have received enough information from your Doctor, clinic, support group or the internet to help you manage your pain?

a. Yes

b. No

76%

24%

Are you looking for new or different medications which may perform better than your current prescription?

a. Yes b. I would like to meet the doctor before I decide

c. No thanks

37%

43%

21%

Would you consider joining a clinical study if the doctor conducting the study was not your own doctor?

15%

6%

4%

1%

9%

16%

11%

3%

19%

2% 1%

2%

10%

3%

Where would be a good place to put the messages about our research study? (pick 2)

Which image would be effective in getting your attention about a diabetic neuropathy clinical trial?

33% 19% 20%

13% 11% 4%

USA PI PDNP Survey Results

www.pdnprecruitment.com

a. Nurse with Patient - - -

b. Barbed Wire - - - - - - -

c. Wringing Hands - - - - -

d. Flaming Hands & Feet -

e. Foot Examination - - - -

f. Walking on Nails - - - - -

0% 0%

8%

55%

5%

32%

Which image would be effective in getting your attention about a diabetic neuropathy clinical trial?

www.Tiredofcrohns.com Completed in 6 days

Google Word Search

9,700 patients in Facebook Forum

Patient Attitudinal Research

How long did it take before you received the

accurate diagnosis you had Crohn's Disease

a. Less than 1 year 36%

b. 1 year 7%

c. 2 years 15%

d. 3 years 8%

e. More than 3 years 33%

Do you have concerns about

receiving infusion therapy (IV's)

40%

60%

Are you concerned or apprehensive

about needles and or injections?

30%

70%

If you currently take medication for Crohn's, how would you

feel about joining a study in which some of the participants

will receive a placebo?

42%

16%

10%

32% a. No thanks

b. I'd need to know mychances of getting theplacebo

c. No big deal, I'm game

d. It depends on how good thisdrug is

How willing would you be to undergo a colonoscopy

if it was required to join the study?

35%

25%

40%

a. No thanks

b. No big deal, I'm game

c. It depends on how good this drug isto see if it is worth it

Would you be willing to join a clinical trial

if the physician is not your primary

doctor?

60%

40%

a. Yes

b. No

Where would be a good place to put messages

about our clinical trial (pick 2)?

Are Crohn’s Suffers Athletes?

PatientQuest

Chronic Pain

Patient Attitudinal Research

Google Word Search

Facebook ad words

20

45

16

25

13

32

5

1

Worried, Concerned

Annoyed, Angry, Frustrated; Don't

Understand

Indifferent; Unsympathetic

Empathetic, Sympathetic

Helpless, Don't know what to do

Sorry or Sad for me Gets in the way of our lives; Is hurting

our relationship

They don't believe anything is wrong

with me but I know what I feel and it isn't right and not

fair

What would be one word to describe how your family feels about your Chronic Pain?

67

8 5

4

46

4

1

108

2 0

20

40

60

80

100

120

Facebook networks

Local chapters of Chronic

Pain suppport groups

Churches Newspaper Doctor's office Pharmacy Health food stores

Internet sites about Chronic

Pain

Grocery store pharmacy

aisle

Where would you most likely learn about Chronic Pain Clinical Trials?

Places to learn about Chronic Pain Clinical Trials

Nu

mb

er

of

Re

spo

nse

s

42, 16%

27, 11%

47, 18%

29, 11%

14, 5%

15, 6% 7, 3%

39, 15%

7, 3% 32, 12%

Which image represents how the chronic pain makes you feel; which do you relate to?

Chronic Pain 1

Chronic Pain 2

Crushed by Pain

Pain-Back

Pain-Barbed

Pain-Bolt

Pain-Cracks

Pain-Masks

Stamp Out

Weight of World

Select the Best Image

Which Images Resonate with Patients

Which Would You Select

What is Wrong with this

Diabetes Representation?

Which better represents OAB?

What image would get your attention so you

might consider learning more about a Crohn's

clinical study?

What image would get your attention so you

might consider learning more about a Crohn's

clinical study?

28% 16% 9.5% 8%

RA Survey Results-Images

Survey Results-Images

Survey Results-Images

Survey Results-Images

47/163 = 29%

19/163 = 12%

9/163 = 6%

56

Participants have expectations:

• What are the potential side effects

• Speak to the PI at every visit

• All travel / parking expenses provided

• A strong desire to meet other participants

• Create a supportive website just for the

study participants

• A mechanism to tell friends about the study

• Progress reports and lab results through

the trial on how they are responding to

treatment

Overarching Solutions

• Sponsors and CROs need a better understanding of barriers to participation (physical and emotional) and the Value Proposition to overcome them

• Sites require continuous training in effective listening, communication skills and handling objections

• Caregivers should be viewed as integral to the successful study completion

Question and Answers

• Content Discussion

What is Most Important to

Potential Participants

Similarity of Patient Responses

in Three Therapeutic Areas

PatientQuest Surveys HIV >250 responses OAB >400 responses Psoriasis > 50 responses

2008 Clinical Research

Educational Conference

60

Which would most likely affect your

decision to participate in a trial?

55

117

32

65

50

90

59

20

0

20

40

60

80

100

120

140

Study

Dur

atio

n

Possible S

ide

Effect

s

Com

pens

atio

n

Req

uire

d Num

ber o

f Visits

Free

Med

icat

ion

Dista

nce

from

Inve

stig

atio

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ic

All of

the

Above

Oth

er

Nu

mb

er

of

res

po

ns

es

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Responses

Percentage

HIV Patients

2008 Clinical Research

Educational Conference

61

Over Active Bladder Patients

0 20 40 60 80 100 120 140 160

Possible side effects of the study medication

Possibility of receiving a placebo (sugar pill)

Taking the medication correctly

Birth contro l requirements

Getting to an appointment

Having to sit too long in the waiting room before being seen

Scheduling study appointments in my already busy schedule

Number of required study visits

Duration or how long the study will last

If this drug will do me any good

Driving distance to the study clinic

Other

2008 Clinical Research

Educational Conference

62

Psoriasis Patients

Decision to participate in clinical trial

05

10152025303540

leng

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poss

ible side

effe

cts

com

pens

ation

requ

ired num

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2008 Clinical Research

Educational Conference

63

Other than receiving a new medical treatment for

OAB, what else would interest you in joining and

remaining in a clinical research study?

0 20 40 60 80 100 120 140

On-going discussions with a uro logy specialist

A trusted web site(s) for OAB information

Empathic listening to how OAB disrupts my life

Advice on how to get on with a normal active life

Exercises to strengthen my bladder

Recipes that help promote a healthy bladder

Prevention

Surgery or some other means of permanent cure

US Results

2008 Clinical Research

Educational Conference

64

Other than receiving a new medical treatment for

OAB, what else would interest you in joining and

remaining in a clinical research study?

0 5 10 15 20 25 30

On going discussions with a urology specialist

A trusted web site(s) for OAB information

Empathic listening to how OAB disrupts my life

Advice on how to get on with a normal active life

Exercises to strengthen my bladder

Recipes that help promote a healthier bladder

EU Results

2008 Clinical Research

Educational Conference

65

Which of the following would keep you interested

in participating in a study for a year or longer?

107 103 101 9986 83

0

20

40

60

80

100

120

Vou

cher

s fo

r tra

vel o

r park

ing

App

ointm

ent r

eminder

not

ice

Opp

ortu

nity to

meet

oth

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artic

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s

Prin

tout

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ing

appo

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Feedba

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...

Mon

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Nu

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Resp

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0%10%20%30%40%50%60%70%80%90%100%

Responses

Percentage

HIV

66

Which would keep you interested in a

study for 3 months or longer?

0 20 40 60 80 100 120 140 160 180 200

Free local or national support group

membership

Opportunity to meet other participants involved

in the trial, in a group setting

"Thank you" letters after kept medical

appointments

Appointment reminder notice by mail or email

Telephone reminder prior to my next

appointment

Monthly newsletter containing OAB related

information

"Appreciation items" when completing

milestones in the study (up to $50 total)

The hope of relief from my symptoms

Having access to my records the end of the

study

Other

USA OAB Patients

67

Which would keep you interested in a

study for 3 months or longer?

0 10 20 30 40 50 60

The possibility of relief from my symptoms

Regular access to a specialist doctor

Free local or national support group membership

Opportunity to meet other participants involved in the trial, in a group setting

M onthly newsletter containing OAB related information

Telephone reminder prior to my next appointment

Appointment reminder notice by mail or email

Vouchers for travel expenses and parking

Having access to my records and progress during the study

"Thank you" letters after kept medical appointments

"Appreciation items" when completing milestones in the study

Other

EU OAB Patients

2008 Clinical Research

Educational

Conference

68

What would keep you interested in a 3 month trial

0

5

10

15

20

25

30

35

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Psoriasis Patients