1. Improving Enrollment through Patient
Attitudinal Insight, Study Viability
Assessments and Operational Best
Practices
ACRP Pacific Northwest Chapter
September 2012 Meeting
John Needham
215-348-3237 office
215-534-7421 mobile
jneedham@needhamandco.com
2. 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
3. A Recruitment Strategy is
…a systematic process to review our
lessons learned, analyze the subjects’
motives and potential barriers and
develop a plan to generate predictable
results.
4. 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
7. 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
8. 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
China, Hong Kong
Colombia, Bogota
• 1 focus group (5 respondents)
• 1 focus group (6 respondents)
• 2 individual depth interviews
• 4 individual depth interviews
Germany, Köln
• 1 focus group (6 respondents)
• 4 individual depth interviews
9. 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
10. 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?”
11. 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.”
12. What is Most Important
to Potential Participants
Similarity of Patient Responses
in Different Therapeutic Areas
13. Which would most likely affect your
decision to participate in a trial?
HIV Patients
140 100%
90%
Number of responses
117
120
80%
100 90 70%
80 60%
65
59 50%
55
60 50
40%
40 32 30%
20 20%
20
10%
0 0%
ic
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14. Over Active Bladder Patients
Other
Driving distance to the study clinic
If this drug will do me any good
Duration or how long the study will last
Number of required study visits
Scheduling study appointments in my already busy schedule
Having to sit too long in the waiting room before being seen
Getting to an appointment
Birth control requirements
Taking the medication correctly
Possibility of receiving a placebo (sugar pill)
Possible side effects of the study medication
0 20 40 60 80 100 120 140 160
15. Psoriasis Patients
Decision to participate in clinical trial
40
35
30
25
20
15
10
5
0
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t io i sit t io nic ov he
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16. Which of the following would keep you interested in participating
in a study for a year or longer?
HIV 120 107 103 101 100%
Number of Responses
99 90%
100 86 83 80%
80 70%
60%
60 50%
40%
40 30%
20 20%
10%
0 0%
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17. Which would keep you interested in a study for 3
months or longer?
USA OAB Patients
Other
Having access to my records the end of the
study
The hope of relief from my symptoms
"Appreciation items" when completing
milestones in the study (up to $50 total)
Monthly newsletter containing OAB related
information
Telephone reminder prior to my next
appointment
Appointment reminder notice by mail or email
"Thank you" letters after kept medical
appointments
Opportunity to meet other participants involved
in the trial, in a group setting
Free local or national support group
membership
0 20 40 60 80 100 120 140 160 180 200
18. Which would keep you interested in a
study for 3 months or longer?
EU OAB Patients
Other
"Appreciation items" when completing milestones in the study
"Thank you" letters after kept medical appointments
Having access to my records and progress during the study
Vouchers for travel expenses and parking
Appointment reminder notice by mail or email
Telephone reminder prior to my next appointment
M onthly newsletter containing OAB related information
Opportunity to meet other participants involved in the trial, in a group setting
Free local or national support group membership
Regular access to a specialist doctor
The possibility of relief from my symptoms
0 10 20 30 40 50 60
19. co
m
pe
ns
at
e
tra
su ve
pp l
10
15
20
25
30
35
0
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t gr ns
ou es
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ee be
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Psoriasis Patients
tte
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de
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ite
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What would keep you interested in a 3 month trial
ot
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r
20. CareforPE
Attitudinal Research
Insights
420 responses in <1 week
10 countries OUS
10% enrollment after 90% of
time
Agency never tested message
21. Untested Image: Effective?
Countries:
Austria
Belgium
France
Germany
Italy
NL
Spain
Sweden
UK
Bulgaria
Czech Rep
Hungary
Poland
Romania
22. 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
23. 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
24. 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
25. 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
26. 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
28. Patient Attitudinal Research
www.Tiredofcrohns.com
Completed in 6 days
Google Word Search
9,700 patients in Facebook Forum
29. In one word or two words can you describe
how Crohn's affects your quality of life
Greatly, Badly , severely diminished cannot walk, swelling of
Unpredictability Colon
NO ENERGY, run down , exhaustion, terrifying
tired ruined my life 2
Disruptive, discomfort debilitating
balancing act affects brain; depressing
Daunting , challenging Stress, stress and only stress
inconvenient but my case is very mild life stopped; destroyed
always present took away my freedom
confined to my home a great uncomfortable
deal 2 Drastically restricting
embarrassed I try not letting it affect me too
constantly tired and underweight much
frustrated, irritable Significantly, varies - not
devastating now.
What Life? I have a part-time life definitely disabling
more worried completely and totally
need to know where the bathrooms limits it
are SELF DESTRUCTION
painful and unpleasant "Up/Down“
sexual problems irritating & annoying
cannot work, 2 scared
30. What would be one word to describe how
your family feels about your Crohn's
concerned /worried 12 Uncomfortable
supportive 6 terrified
understanding/helpless 6 adjustment
Sympathetic 5 not too much
Sad 5 helpful
hating 4 too much expenses on meds
confused 3 nothing
misunderstanding 2 considerate
devastation 2 limited
overwhelmed 2 frustration
compassionate 2 IGNORANT
empathetic cancer would be better
Acceptance tired
anxious Wish we could make it disappear
unfortunate upset
Inconvenient Doesn't matter to them
31. Do you have concerns about receiving
infusion therapy (IV's)
40%
60%
32. Are you concerned or apprehensive
about needles and or injections?
30%
70%
33. Where would be a good place to put messages
about our clinical trial (pick 2)?
34. 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
38. What is your age range?
51 - 80 124
Age Ranges
36 - 50 91
18 - 35 44
Number of Responses
39. What type of doctor do you see regularly
for your pain?
44, 12%
Primary care
18, 5%
Orthopedic specialist
151, 40%
37, 10%
Pain management specialist
Neurologist
89, 23%
Psychiatrist
38, 10%
Other
40. My pain feels like (fill in the blank):
5, 4% Prison; Constant pain throughout the body
11, 9% A constant toothache but in the lower back
Someone is torturing me
14, 12%
I'm being crushed; every bone in my body is
39, 33% broken
Throbbing; at times Excruciating
13, 11%
Aggrevation; Unbearable; Controls Me
I have been repeatedly run over by a semi.
10, 9% Or crushed with a hammer
7, 6% Fire, Burning, stabbing; Sharp Pains;
15, 13% Lightning; Hell
4, 3% 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,
41. What one or two words describe how Chronic Pain
affects your quality of life?
1, 1%
Dibilitating / Tiring / Causes Fatigue
8, 5%
16, 9% Destroys / Ruins / No QOL / What
Life? / Depressed
20, 12% 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
16, 10% number of things now / ADL
Worrysome
62, 37% Hate it; Sucks
Excruiating
24, 14%
Confining / Limiting / Feeling like a
Prisoner
Frustrating / Annoying / Stressful
3, 2% 14, 8%
1, 1%
Driving/ Alertness / Availability
2, 1%
42. How far/long would you be willing to travel
to be in a Chronic Pain clinical trial?
120
100
97
Number of Responses
80
60 63 59
40
20 21
0
< 15 minutes < 30 minutes Up to an hour More than an
Distance / Time Traveled
hour
43. 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
134, 9% A list of the possible side effects
179, 12%
Information on compensation such as
travel costs
204, 14%
157, 11% 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
137, 9%
202, 13% I would like information for my family so
they understand the study
Flexible office hours to accommodate our
120, 8% family schedule
Information on my rights as a participant
156, 10%
and the privacy of my medical records
156, 10%
65, 4% I would like to speak with a pain specialist
whenever I have questions or need
answers
44. What might impact your decision when considering
participation in a clinical study that lasts for about 3
months? Check all that apply:
Location of Doctor's office
36,
4%
Length and number of office
126, 15% visits required for
206, 24%
participation
Effectiveness of study drug
If my travel costs and parking
141, 17%
will be paid for
164, 19%
How long each doctor visit
will be
176, 21% Other
45. Where would you most likely learn about
Chronic Pain Clinical Trials?
120
108
100
80
67
60
46
40
20
8
5 4
4 2
0 1
Facebook Local chapters Churches Newspaper Doctor's office Pharmacy Health food Internet sites Grocery store
networks of Chronic stores about Chronic pharmacy
Pain suppport Pain aisle
groups
Places to learn about Chronic Pain Clinical Trials
46. Which image represents how the chronic pain
makes you feel; which do you relate to?
32, 12% Chronic Pain 1
7, 3% 42, 16%
Chronic Pain 2
Crushed by Pain
Pain-Back
39, 15% 27, 11%
Pain-Barbed
Pain-Bolt
Pain-Cracks
7, 3% 47, 18%
15, 6% Pain-Masks
14,
Stamp Out
5%
29, 11% Weight of World
48. Do you feel that your Doctor understands your
condition?
32% 34% a. Not as concerned
as I would like
b. Yes
c. No
34%
49. Do you feel that you have received
Are you looking for new treatment
enough information from your Doctor,
options or different medications
clinic, support group or the internet to
which may perform better than your
help you manage your condition?
current prescription?
70%
63%
60%
60%
50%
40%
37% 40%
30%
20%
10%
0%
a. Yes b. No a. Yes b. No
50. Are you experiencing unwanted side Are your side effects unpleasant
effects from your current medication? enough to interest you other
medical therapies?
49%
50% a. Yes
51% 50%
No
b. No
Yes
51. 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) ?
43%
22%
17% 18%
a. No thanks, my symptoms b. I'd be willing to change c. Not sure. I'd need more d. I need to check with my
are too severe my current medication to information before deciding doctor first
join the study
52. What are your top 3 reasons for considering
a clinical trial?
My current drug is not
working well enough I don’t like the side
It's too late for me, but Other (please be
15% effects of my current
I'd participate to help specific) drug
others 7% 7%
19%
I can not afford the
prescriptions and this is
a way for me to get
treatment
5%
I know someone who was
in a trial and it helped COPD prevents me from
4% My doctor thought it participating in certain
would be a good idea physical activities
6% 37%
53. What are your top 3 concerns about enrolling
in a clinical trial?
Other (please be
Possible side effects of
specific)
Driving distance to the the study medication
2%
study clinic 18%
17%
Possibility of
If this drug will do me receiving a placebo
any good 18%
15%
Taking the medication
correctly
Duration or how long 1%
the study will last
6%
Number of required
Having to sit too long in
study visits Scheduling study
the waiting room before Getting to an
8% appointments in my
being seen appointment
already busy schedule
5% 7%
3%
54. Whose recommendation about a clinical trial
would you respect the most?
The internet Other (please be
5% specific)
What I see
7%
on TV shows like Oprah
0%
Pharmacist
1%
A previous trial
participant
9%
One of my friends
1%
Family doctor (GP)
16%
Pulmonologist
61%
A nurse
0%
55. Where do you look for or find most of your
health information?
RA Crohn's COPD Depression OAB
43%
42%
38%
31%
28%
23%
21%
18% 18% 18%
16%
13%
12%
10% 10%
5% 6% 6%
4%
2%
0%
The Internet Doctor Books or Newpaper Support Groups
Magazines Articles
56. Would a dedicated website for the study
keep you interested in participating?
87% 87%
76%
Psoriasis COPD OAB HIV
69%
31%
24%
13%
13%
Yes
No
57. The Recruitment Metaphor
1 Fish where the fish are.
2 Know what they are biting on.
3 Know who the Keepers are.
4 Find the best fishermen.
58. 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
59. 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
60. Proven Solution #1
Possible side effects sheet
Taken from protocol
Handed to each participant
72. Examples of a CROs Branding
Will this help Enrollment?
72
73. Study Identity – Important, but
Will these Tools help Enroll patients?
Wallet
Welcome Appointment Card
Letter
Distraction
items for
study visits
Emergency
Card
Backpack for study
medication
