John Needham Northwestern U lecture

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

2008 Clinical Research Educational Conference 2

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


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


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?


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


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


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


Retention Challenges


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


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


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)


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


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


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


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


Psoriasis PatientsDecision to participate in clinical trial

05

10152025303540


Would you discuss trial participation with a partner, friend or family

member?

Yes, 183

No, 16

YesNo


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


PsoriasisWith whom besides your Doctor would you discuss

decision on trial participation?

05

10152025303540

immediate familymembers

special services therapist other


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


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


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


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


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


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


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


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


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


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


What would keep you interested in a 3 month trial

05

101520253035

Psoriasis Patients


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


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


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)


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!


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”


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

John Needham Northwestern U lecture

Health & Medicine

Transcript of John Needham Northwestern U lecture