John Needham.Patient Thoughts

What is Most Important to Potential Participants

Similarity of Patient Responses in Three Therapeutic Areas

John Needham’s PatientQuest Surveys

HIV >250 responsesOAB >400 responsesPsoriasis > 50 responses

2008 Clinical Research Educational Conference 2

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

3

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

2008 Clinical Research Educational Conference 4

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

ation

Possib

le Side E

ffects

Compe

nsati

on

Requir

ed Num

ber o

f Visi

ts

Free M

edica

tion

Distan

ce fr

om In

vesti

gatio

n Clin

ic

All of t

he A

bove

Other

Nu

mb

er o

f res

po

nse

s

0%10%20%30%40%50%60%70%80%90%100%

Responses

Percentage

HIV Patients

2008 Clinical Research Educational Conference 5

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 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

2008 Clinical Research Educational Conference 6

Psoriasis PatientsDecision to participate in clinical trial

05

10152025303540

length of

stud

y

poss

ible sid

e effe

cts

compe

nsati

on

requ

ired n

umbe

r of v

isits

free m

edica

tion

distanc

e from st

udy c

linic

all of

the a

bove

other

7

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

member?

Yes, 183

No, 16

YesNo

2008 Clinical Research Educational Conference 8

If considering an OAB 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

OAB US responders

2008 Clinical Research Educational Conference 9

PsoriasisWith whom besides your Doctor would you discuss

decision on trial participation?

05

10152025303540

immediate familymembers

special services therapist other

2008 Clinical Research Educational Conference 10

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

2008 Clinical Research Educational Conference 11

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

Prevention

Surgery or some other means of permanent cure

US Results

2008 Clinical Research Educational Conference 12

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 13

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

Internet responses

Inner-city responses

2008 Clinical Research Educational Conference 14

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

2008 Clinical Research Educational Conference 15

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

Internet responses

Inner-city responses

2008 Clinical Research Educational Conference 16

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

2008 Clinical Research Educational Conference 17

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

Vouch

ers f

or tra

vel o

r parki

ng

Appoin

tmen

t rem

inder

not

ice

Oppor

tunit

y to m

eet ot

her p

artic

ipants

Printo

ut o

f upco

ming

appo

intm

ents

Feedba

ck ca

rds t

o co

mmen

t on

the

...

Mon

thly

newsle

tter

Nu

mb

er o

f R

esp

on

ses

0%10%20%30%40%50%60%70%80%90%100%

Responses

Percentage

HIV

18

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

2008 Clinical Research Educational Conference 19

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

2008 Clinical Research Educational Conference 20

What would keep you interested in a 3 month trial

05

101520253035

com

pens

ate

trave

l exp

ense

s

supp

ort g

roup

mem

bers

hip

mee

t oth

er p

artic

ipants

"than

k yo

u" le

tters

rem

inde

r not

ice

tele

phon

e re

min

der

mon

thly

newsle

tter

"app

recia

tion

item

s"

othe

r

Psoriasis Patients

21

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

22

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

23

7 Take Away Messages• Assess the feasibility for every study• Whatever you or anyone thinks will work, it

must be tested and proven; budget for it• Develop a site Recruitment Training Continuum• 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”