Improving Enrollment through Patient

Attitudinal Insight, Study Viability

Assessments and Operational Best

Practices

John Needham 215-348-3237 office

215-534-7421 mobile jneedham@needhamandco.com

ACRP Pacific Northwest Chapter September 2012 Meeting

Learning Objectives Review 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 we use this insight to better approach patients

…a systematic process to review our

lessons learned, analyze the subjects’

motives and potential barriers and

develop a plan to generate predictable

results.

A Recruitment Strategy is

Uncover Barriers in Recruitment

“What might get in the way of your participation?”

Logistical Barriers – time, transportation, cost

Attitudinal Barriers – what if randomized to their less preferred group

Social Barriers – quality and quantity of family support

Health Barriers – complicating co-morbid medical or emotional conditions

Work Barriers – job travel or anticipated job changes, schedule flexibility

Patient Attitudinal

Research Regarding Study

Participation

What have we learned and how can it help us enroll and

keep patients

Deficit Needs

Being Needs

Maslow’s Hierarchy of Needs

Apply the Data to Our Strategy

Determine the recruitment difficulty level

Project enrollment ratios (time, money and

staffing)

Shape awareness, patient education plan

Ensure relevance to your patient population

Prepare all the site staff

Understand what retention challenges will be

The Old Way: Interviews with 27

diabetes patients cost $140,000 Qualitative research conducted in Germany, Hong Kong and

Colombia In each country;

one focus group (each 90-120 minutes) with type 2 diabetes sufferers with chronic renal insufficiency and inadequate glycemic control

individual depth interviews (each 45-60 minutes) with type 2 diabetes sufferers with end-stage renal disease who have been on dialysis for at least 6 months and have inadequate glycemic control

Colombia, Bogota

• 1 focus group (6 respondents)

• 4 individual depth interviews

China, Hong Kong

• 1 focus group (5 respondents)

• 2 individual depth interviews

Germany, Köln

• 1 focus group (6 respondents)

• 4 individual depth interviews

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 Oncology 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.”

What is Most Important

to Potential Participants

Similarity of Patient Responses

in Different Therapeutic Areas

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

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s

Com

pens

atio

n

Req

uire

d Num

ber o

f Visits

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icat

ion

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stig

atio

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ic

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the

Above

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er

Nu

mb

er

of

res

po

ns

es

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Responses

Percentage

HIV Patients

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

Psoriasis Patients Decision to participate in clinical trial

05

10152025303540

leng

th of s

tudy

poss

ible side

effe

cts

com

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requ

ired num

ber o

f visits

free

med

icat

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e from

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dy clin

ic

all o

f the

abo

ve

othe

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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

er p

artic

ipant

s

Prin

tout

of u

pcom

ing

appo

intm

ents

Feedba

ck card

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...

Mon

thly new

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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

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

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

What would keep you interested in a 3 month trial

0

5

10

15

20

25

30

35

com

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supp

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tters

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Psoriasis Patients

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

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?

Messages: help each other, increase positive experience, decrease anxiety and sexual frustration

Surprise! Failed Image: why?

www.Tiredofcrohns.com Completed in 6 days

Google Word Search

9,700 patients in Facebook Forum

Patient Attitudinal Research

In one word or two words can you describe

how Crohn's affects your quality of life Greatly, Badly , severely diminished Unpredictability NO ENERGY, run down , exhaustion,

tired Disruptive, discomfort balancing act Daunting , challenging inconvenient but my case is very mild always present confined to my home a great

deal 2 embarrassed constantly tired and underweight frustrated, irritable devastating What Life? I have a part-time life more worried need to know where the bathrooms

are painful and unpleasant sexual problems cannot work, 2

cannot walk, swelling of Colon

terrifying ruined my life 2 debilitating affects brain; depressing Stress, stress and only stress life stopped; destroyed took away my freedom uncomfortable Drastically restricting I try not letting it affect me too

much Significantly, varies - not

now. definitely disabling completely and totally limits it SELF DESTRUCTION "Up/Down“ irritating & annoying scared

What would be one word to describe how

your family feels about your Crohn's

concerned /worried 12 supportive 6 understanding/helpless 6 Sympathetic 5 Sad 5 hating 4 confused 3 misunderstanding 2 devastation 2 overwhelmed 2 compassionate 2 empathetic Acceptance anxious unfortunate Inconvenient

Uncomfortable terrified adjustment not too much helpful too much expenses on meds nothing considerate limited frustration IGNORANT cancer would be better tired Wish we could make it disappear upset Doesn't matter to them

Do you have concerns about receiving

infusion therapy (IV's)

40%

60%

Are you concerned or apprehensive

about needles and or injections?

30%

70%

Where would be a good place to put messages

about our clinical trial (pick 2)?

Where do you look on the Internet? Google it 12 Crohn's sites support group, CCFA 10 Web MD 9 HealingWell.com 5 Facebook. 3 Inspire page 3 yahoo search 2 forums 2 mayo clinic, 2 online medical journals Cleveland Clinic, John's Hopkins website Oley group medicinenet.com, livingwithcrohns, Crohn's networks clinical trials.gov nacc nhs web, md junction support group

Are Crohn’s Suffers Athletes?

…or do they look like this?

Chronic Pain

Patient Attitudinal Research

Google Word Search

Facebook ad words

44

91

124

18 - 35

36 - 50

51 - 80

What is your age range?

Number of Responses

Age

Ran

ges

What type of doctor do you see regularly

for your pain?

151, 40%

38, 10%

89, 23%

37, 10%

18, 5%

44, 12%

Primary care

Orthopedic specialist

Pain management specialist

Neurologist

Psychiatrist

Other

11, 9%

14, 12%

13, 11%

10, 9%

4, 3% 15, 13%

7, 6%

39, 33%

5, 4%

My pain feels like (fill in the blank): Prison; Constant pain throughout the body

A constant toothache but in the lower back

Someone is torturing me

I'm being crushed; every bone in my body is broken

Throbbing; at times Excruciating

Aggrevation; Unbearable; Controls Me

I have been repeatedly run over by a semi. Or crushed with a hammer

Fire, Burning, stabbing; Sharp Pains; Lightning; Hell

Something I just want to go away and never come back

Comments with fewer than 4 responses: Terrible, unmanageable, unable to take much more, My head lives in a vice that crushes my head near implosion, My body is literally falling apart, Sometimes I'm dying, other times I wish I was, Stiffness and pain in my joints, Liquid metal running through my neck and spine, Constant, extreme menstrual cramps as bad as "birth & labor" pain, Breaking in half at back traveling down right leg; extreme leg pain, An axe splitting my head in two, rocks in my shoulders, neck, and lower back, spikes in joints, Death, Insides being pulled out

16, 9%

62, 37%

1, 1% 2, 1%

14, 8% 3, 2%

24, 14%

16, 10%

20, 12%

8, 5%

1, 1%

What one or two words describe how Chronic Pain affects your quality of life?

Dibilitating / Tiring / Causes Fatigue

Destroys / Ruins / No QOL / What Life? / Depressed I concider suicide everyday because of no end to pain ever I can not describe it but it ia always there Slows me down / Unable to do a number of things now / ADL Worrysome

Hate it; Sucks

Excruiating

Confining / Limiting / Feeling like a Prisoner Frustrating / Annoying / Stressful

Driving/ Alertness / Availability

How far/long would you be willing to travel

to be in a Chronic Pain clinical trial?

63

97

59

21

0

20

40

60

80

100

120

< 15 minutes < 30 minutes Up to an hour More than an hour

Nu

mb

er

of

Re

spo

nse

s

Distance / Time Traveled

134, 9%

204, 14%

202, 13%

156, 10%

65, 4%

156, 10%

120, 8%

137, 9%

157, 11%

179, 12%

What information could we provide you so you would be able to make a good decision about whether a clinical trial is right for you? Check all that apply: An informational website my family

doctor could review

Information on what is required of me as a participant

A list of the possible side effects

Information on compensation such as travel costs

I would like to speak to other study participants before enrolling and during the study I would like access to my medical records and any test results

I would like information for my family so they understand the study

Flexible office hours to accommodate our family schedule

Information on my rights as a participant and the privacy of my medical records

I would like to speak with a pain specialist whenever I have questions or need answers

206, 24%

164, 19%

176, 21%

141, 17%

126, 15%

36, 4%

Location of Doctor's office

Length and number of office visits required for participation

Effectiveness of study drug

If my travel costs and parking will be paid for

How long each doctor visit will be

Other

What might impact your decision when considering

participation in a clinical study that lasts for about 3

months? Check all that apply:

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

COPD Responses

34%

34%

32%

Do you feel that your Doctor understands your condition?

a. Not as concerned as I would like

b. Yes

c. 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 condition?

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?

51%

49%

Are you experiencing unwanted side effects from your current medication?

Yes

No 50%

50%

Are your side effects unpleasant enough to interest you other

medical therapies?

a. Yes

b. No

17%

22%

43%

18%

a. No thanks, my symptoms are too severe

b. I'd be willing to change my current medication to

join the study

c. Not sure. I'd need more information before deciding

d. I need to check with my doctor first

How would you feel about joining a research study in which you will be required to stop using your current medication; some patients will receive the study drug

and some may be given a placebo (sugar pill) ?

What are your top 3 reasons for considering

a clinical trial?

I can not afford the

prescriptions and this is

a way for me to get

treatment

5%

 It's too late for me, but

I'd participate to help

others

19%

Other (please be

specific)

7%

I don’t like the side

effects of my current

drug

7%

My current drug is not

working well enough

15%

 My doctor thought it

would be a good idea

6%

I know someone who was

in a trial and it helped

4%

 COPD prevents me from

participating in certain

physical activities

37%

What are your top 3 concerns about enrolling

in a clinical trial?

 Number of required

study visits

8%

 Duration or how long

the study will last

6%

 If this drug will do me

any good

15%

 Driving distance to the

study clinic

17%

 Other (please be

specific)

2%

Scheduling study

appointments in my

already busy schedule

3%

 Possibility of

receiving a placebo

18%

 Possible side effects of

the study medication

18%

Getting to an

appointment

7%

 Having to sit too long in

the waiting room before

being seen

5%

Taking the medication

correctly

1%

Whose recommendation about a clinical trial

would you respect the most? Other (please be

specific)

7%

 Pharmacist

1%

 What I see

on TV shows like Oprah

0%

 The internet

5%

A nurse

0%

Pulmonologist

61%

 One of my friends

1%

 A previous trial

participant

9%

 Family doctor (GP)

16%

The Internet Doctor Books or Magazines

Newpaper Articles

Support Groups

43%

16%

38%

31%

0%

42%

28%

18%

5% 6%

13%

21%

18%

4% 6%

12%

23%

18%

10% 10%

2%

Where do you look for or find most of your health information?

RA Crohn's COPD Depression OAB

Yes

No

76%

24%

87%

13%

69%

31%

87%

13%

Would a dedicated website for the study keep you interested in participating?

Psoriasis COPD OAB HIV

1 Fish where the fish are.

2 Know what they are biting on.

3 Know who the Keepers are.

4 Find the best fishermen.

The Recruitment Metaphor

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

Most Important to Potential Participants

Regardless of the condition, addressing potential side effects with a potential participant is of paramount importance

Participants need user friendly literature about the study to share with their family and their family doctor

Participants want to talk with specialists or providers on an on-going basis if they are going to remain in a study

Proven Solution #1

Possible side effects sheet Taken from protocol Handed to each participant

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%

72

Examples of a CROs Branding

Will this help Enrollment?

Study Identity – Important, but Will these Tools help Enroll patients?

Backpack for study medication

Wallet

Distraction items for study visits

Emergency Card

Appointment Card Welcome Letter

Content Discussion

Question and Answers