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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
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
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%
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%
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
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
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%
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
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
n Clin
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
th of s
tudy
poss
ible side
effe
cts
com
pens
ation
requ
ired num
ber o
f visits
free
med
icat
ion
distanc
e from
stu
dy clin
ic
all o
f the
abo
ve
othe
r
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
er p
artic
ipant
s
Prin
tout
of u
pcom
ing
appo
intm
ents
Feedba
ck card
s to
com
men
t on
the
...
Mon
thly new
slette
r
Nu
mb
er
of
Resp
on
ses
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
com
pens
ate
trave
l exp
ense
s
supp
ort g
roup
mem
bers
hip
mee
t oth
er p
artic
ipan
ts
"than
k yo
u" le
tters
rem
inde
r not
ice
tele
phon
e re
min
der
mon
thly n
ewslet
ter
"app
reciat
ion
item
s"
othe
r
Psoriasis Patients