Post on 11-Jul-2015
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
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
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
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
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
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
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
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