Assessing, Understanding And Addressing The Needs Of
Potential Study Participants And Their Families
John NeedhamCEOPatient Recruitment Strategy, LLCPatientQuestClinical Trial Brands
2008 Clinical Research Educational Conference
What Focus Group Research Has Taught Us About Motivations and Barriers to Clinical Trial Participation
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Today’s Topics• The steps sponsors and site staff need to take
to better recruit and retain participants• Understanding the relevance of Maslow’s
Hierarchy of Needs to trial participation• The results of recent participation surveys
indicating participants greatest needs• Examples of patient education materials used
to help participants overcome barriers to study participation
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What Brings Us Together…?
• Recruitment is never going to be easier, only more difficult: more patients---longer trials
• An opportunity exists to more effectively initiate studies, build patient awareness, improve retention and achieve your evaluable patient data goals
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Know The Patient’s Mindset• How do they feel about their disease and the
impact on their daily life.
• Do they know what a clinical trial is?
• What would they want to know about one?
• What would their barriers to participation be?
• What would allay their concerns?
• How far will they travel to a specialist or clinic?
• How do they feel about the study requirements?
• Is there a bias in the severity of the condition?
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Participants’ Information Needs
82%
78%
76%
47%
43%
42%
0% 25% 50% 75% 100%
Answers to FAQs
Directions/logistics
Information on What toExpect on First Visit
Glossary of Terms
General clinical studyinformation
Education about myillness
Percent of Respondents N=968
Source: November 2002 Online Survey
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Study Participants’ Concerns
54%
43%40%
29%27%
21%
0%
30%
60%
Flexible hours Procedures notrisky or invasive
Minimal risk ofside effects
Volunteers notgiven a placebo
Easy to get to bypublic
transportation
Only required afew visits
% Responding
Source: Thomson CenterWatch Survey of 1239 Study Volunteers, 2004
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The Staff’s Bedside Manner
• 78% of patients want the physician to shake their hand during the first encounter
• 56% of patients want physicians to introduce themselves using their own first and last names
• 50% of patients want their first name used by the physician
• 24% of patients want the physician to use their first and last names
Archives of Internal Medicine Survey
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Retention Challenges
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Keeping Participants Engaged
• At any point in time, a participant’s motivation can vary through any aspect of the therapeutic program
• Listen for the signs of loss of interest helping and try to resolve ambivalence
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Barriers
“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
2008 Clinical Research Educational Conference 11Deficit Needs
Being Needs
Maslow’s Hierarchy of Needs
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The Theory of Motivation
1. Physiological (hunger, thirst, shelter, sex)
2. Safety (security, protection from harm) 3. Social (affection, belonging, acceptance,
friendship) 4. Esteem (also called ego). Internal: self
respect, autonomy, achievement; External: status, recognition, attention.
5. Self actualization (doing things, taking positive action steps)
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22%
9% 12%
0%
9% 10% 12%13%
9%14% 10%
45%
9%
37%
19%
49%
11%9%
0%
25%
50%
75%
100%
0-3 Months 4-11 Months 1-2 Years 3-4 Years 4+ Years Diagnosed inthe Trial
Overall Life Threatening Chronic
Source: February 2005 Volunteer Survey
Percent of Respondents N= 534
How Long Did You Have Your Medical Condition How Long Did You Have Your Medical Condition Before You Participated in a Clinical Trial?Before You Participated in a Clinical Trial?
Recruitment Insights
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From The Time You First Heard About The Clinical Trial, How Long Before You Decided To Participate?
40%
30%
16% 15%
48%
38%
9%5%
45%
36%
12% 8%
0%
25%
50%
75%
100%
Same Day 0-1 Week 2-3 Weeks 4 Weeks+
Overall Life Threatening Chronic
Source: February 2005 Volunteer Survey
Percent of Respondents N= 534
What is Most Important to Potential Participants
Similarity of Patient Responses in Three Therapeutic Areas
PatientQuest Surveys
HIV >250 responsesOAB >400 responsesPsoriasis > 50 responses
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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
Nu
mb
er o
f res
po
nse
s
0%10%20%30%40%50%60%70%80%90%100%
Responses
Percentage
HIV Patients
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Over Active Bladder Patients
0 20 40 60 80 100 120 140 160
P ossible side effects of the study medication
P ossibility of receiving a placebo (sugar pill)
Taking the medication correctly
Birth control 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
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Psoriasis PatientsDecision to participate in clinical trial
05
10152025303540
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Would you discuss trial participation with a partner, friend or family
member?
Yes, 183
No, 16
YesNo
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If considering a trial, who, other than the study doctor, would you discuss the decision with?
0 20 40 60 80 100 120 140
Spouse or partner, and immediate family members
Urology specialist
A study nurse
Your family doctor (GP)
One of my friends
My gynecologist
A previous trial participant
Other
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PsoriasisWith whom besides your Doctor would you discuss
decision on trial participation?
05
10152025303540
immediate familymembers
special services therapist other
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If considering a trial, who, other than the study doctor, would you discuss the decision with?
0 5 10 15 20 25 30 35
Spouse or partner, and immediate family members
Your specialist doctor (Urologist; OB/GYN)
A study nurse
Your family doctor (GP)
Friend / carer
Continence support group representative
A previous trial participant
Other
EU Results
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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 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 healthy bladder
P revention
Surgery or some other means of permanent cure
US Results
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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
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11. Do you feel your regular doctor understands how you feel about having OAB?
0 20 40 60 80 100 120 140
Yes
No
31 31.5 32 32.5 33 33.5 34
Yes
No
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Do you feel your regular doctor understands how you feel about having OAB?
0 5 10 15 20 25 30 35 40 45 50
Yes
No
EU Results
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Can you or do you prefer to discuss your OAB with the nurses in your doctor’s office?
0 20 40 60 80 100 120 140
Yes
No
0 5 10 15 20 25 30 35 40
Yes
No
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Can you or do you prefer to discuss your OAB with the nurses in your doctor’s office?
0 5 10 15 20 25 30 35 40
Yes
No
EU Results
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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
120N
um
ber
of
Res
po
nse
s
0%10%20%30%40%50%60%70%80%90%100%
Responses
Percentage
HIV
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Which of the following would keep you interested in participating in a study for 3 months or longer?
0 20 40 60 80 100 120 140 160 180 200
Free local or national support groupmembership
Opportunity to meet other participants involvedin the trial, in a group setting
"Thank you" letters after kept medicalappointments
Appointment reminder notice by mail or email
Telephone reminder prior to my nextappointment
Monthly newsletter containing OAB relatedinformation
"Appreciation items" when completingmilestones in the study (up to $50 total)
The hope of relief from my symptoms
Having access to my records the end of thestudy
Other
USA OAB Patients
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Which of the following would keep you interested in participating 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
Monthly 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
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What would keep you interested in a 3 month trial
05
101520253035
Psoriasis Patients
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Key Findings• 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
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Participants have expectations:
• travel / parking expenses provided • strong desire to meet other participants• supportive website just for the study
participants• mechanism to tell their friends or support
group members about the study• progress reports through the course of the
trial on how they are responding to the treatment
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Barriers to participation are:
• driving too far to a site (pain)
• flexible hours at the site for visits
• too many visits through the course of the study (inconvenience)
• injectable treatment (fear of needles)
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Messages to the SitesHumanize the Experience.
One of the top four motivators for participation in clinical trials among older adults is staff rapport.
Give empathy to the Patient. Pay attention, ask questions.
Be of service to the caregiverLearn about available community resourcesThe smallest kindness means more than you can
imagine to a family caregiver.
Smile and say Thank you!
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7 Take Away Messages1. Assess the feasibility for every study2. Whatever you or anyone thinks will work, it
must be tested and proven; budget for it3. Develop a site Recruitment Training Continuum4. Never underestimate the multiple forces exerted
on the patient’s mind set and their family’s motivation
5. Archive what you have learned6. You are in the business of delivering “Evaluable
Data”7. “Fish where the fish are”
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Tools sites request in surveysOver 90% of sites want:
– Visit by Visit card– A study brochure– A patient/caregiver brochure– Print advert template– A Study web Site– Patient Travel Voucher– Inclusion/exclusion cards– Written “Welcome Letter”– A Farewell Kit– Appointment Reminder
Cards
Over 80% additionally want:– Screening Post it Notes– Study Posters– E-newsletters – PI’s “Dear Patient” letter– Training Webinars