Patient Enrollment Strategy

John Needham

COPD

• A patient or site’s subjective impressions of a study’s value proposition will always trump objective data and will be a better indication of enrollment success

• The most effective recruitment will occur at the Point of Care

• Enrollment can only succeed through well-planned strategies which make business sense and educate the patient

• Effective enrollment and retention requires a thorough understanding of the patient as a human being with an illness

• Studies need ‘top-of-mind’ community awareness, a strong referral network for the PI coupled with site tools and retention materials.

Recruitment Fundamental Tenets

Deficit 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 (Internal: self respect, autonomy, achievement; External: status, recognition, attention)

5. Self actualization (doing things)

Hierarchy of Needs – Study Participants

I’m important; recognition

Group member, Friendly Site

Better treatment; IRB approved

Testing a new therapy

For humanity’s well being

Esteem

Social

Safety

Physiological

Self-Actual

Steps to Recruitment and Retention

Understand, educate and inform the patient

Appeal to patient’s needs

Motivate the patient to enroll

Offer unprecedented care

Provide ongoing attention

Show explicit appreciation

Demonstrate the value of their contribution

Really “KNOW” Your Target Population

• What are their un-met needs and wants?• How do they recreate?• Where do they socialize?• Where do they shop?• Which newspapers or magazines do they read?• Where do they get COPD information on line?• Which radio stations do they listen to?• Which television programs do they watch?• Where or from whom do they get their healthcare information—Internet? Dr. Phil? Oprah? Church?

• Do they belong to a COPD Support Group?

Harris Interactive

What do Participants’ Expect?

• having access to their own test results at the end of the study (90% of potential participants);

• having their expenses paid (89%);• receiving a copy of the clinical protocol (87%);• being paid for their time (77%);• being seen by a doctor on every visit (76%); • Have access to their test results throughout the study (73%)

• should be able to talk with other participants (56%)

If we are not prepared to meet these expectations, we must be prepared to exceed their expectations for levels of Customer Service

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 Before You Participated in a Clinical Trial?

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

If you were participating in a trial, would you discuss it with your personal physician?

Yes, 190

No, 7

YesNo

Which of the following would make you interested in participating in a study?

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

COPD PI Feasibility Research

n=76 participantsUSA, India, Czech Republic, Russia,

Ukraine, Poland, Austria, Lithuania

April 1-8, 2011www.copdrecruitment.com

4%

13%

59%

10%

14%

In previous COPD studies, were you able to achieve your enrollment goals?

a. No, we did not have enough potential participants in our database

b. Yes but we went outside the practice to other clinics

c. Yes with only patients from my practice

d. Yes but we had to go out-side our practice to colleagues' referrals

e. Yes but we needed to use advertisements etc.

a. None b. < 20% c. 20-40% d. 40-60% e. >60%

14%

55%

21%

5% 5%

What percent of your patients with COPD are looking for help/advice on the

internet?

a. None b. < 20% c. 20-40% d. 40-60% e. >60%

44%

51%

4%1% 0%

What percent of your patients with COPD have joined a local support group / Patient Advocacy Group?

a. Would not s

ign the co

nsent f

orm

b. Did not m

eet FEV1 re

quirements

c. Refu

sal t

o with

draw fr

om conco

mittant m

edications t

hey were

taking

d. Hist

ory of d

rug or a

lcohol a

buse

e. Did not s

moke cigare

ttes long enough to

meet t

he crite

ria

f. Cance

r pre

sence

g. Card

iovascular h

istory

or risk

s

h. Oth

er:

7%

57%

17%

0%4% 1%

10%4%

In your previous COPD studies, involving severe to very severe patients, what primarily excluded them during screening? (Pick 1, please)

a. with

drawal of t

heir oth

er medica

tions

b. give up on diary re

cord

ing

c. Too w

eak at times

d. Transp

ortation is

sues

e. Oth

er illnesse

s

f. work co

nflicts

g. lack

of support

within th

e family

/care

giver

h. dru

g, alco

hol abuse

i. transie

nt, unre

achable

j. Weath

er conditions a

re to

o severe

k. Pre

gnancy

32%

10%

6%

13%

21%

3%

8%

0% 1%

6%

0%

In your previous COPD studies, what barriers have impacted severe COPD patients from fully completing

the study?

22%

17%

7%

7%

5%23%

11%

7% 1%

Why would your patients consider a clinical trial (Check all that apply)

a. They like the additional med-ical care they receive as a study participant

b. They may be treatment re-sistant and have tried many other drugs

c. For the benefit of mankind, altruism

d. The best compounds for their condition are not approved in our country

e. Their current meds have unwanted side effects

f. They are looking for any path to feeling better

g. They can not afford their med-ications

h. Because I think it is best for them and recommend the study

i. Other:

a. Distance or travel times are not a factor

b. < 30 minutes c. >30 minutes but < 1 hour

d. More than 1 hour

33%

25%

36%

6%

How far do you think a patient will travel to join such a study?

a. More than one patient per month

b. One patient per month c. One patient every 2 months

d. One patient every 3 months

76%

22%

2%0%

What is an average patient enrollment rate per site, per month for COPD?

a. None

b. < 20%

c. 20-40%

d. 40-60%

e. >60%

0%

7%

42%

32%

20%

What percent of your patients periodically suffer with chronic productive coughs / exacerbation episodes?

Survey:Patients with Chronic Obstructive Pulmonary Disease (COPD) (n=284)

October 2012

How long have you been bothered by COPD?

 6 months to 1 year2% Less than 6 months

1%

 2 to 4 years14%

Longer than 4 years77%

1 to 2 years6%

Where do you look for or find most of your information about COPD?

Your family doctor8%

Your internist2%

The internet28%

Other (please be specific)

3%

 TV shows like Oprah1%

 Health talk-shows on the radio

0%

COPD-related organizations

16% Books or magazines5%

Support groups13%

 Newspaper or magazine articles

6%

Your pulmonologist18%

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

drug7%

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

helped4%

 COPD prevents me from participating in certain

physical activities37%

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 schedule3%

 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 seen5%

Taking the medication correctly

1%

Which of the following would most likely affect your decision as to whether you would participate in a COPD clinical trial?

Required number of visits11%

Free medication7%

Distance from study clinic24%

 Other (please be specific)

2%

 Number of Blood Tests2%

 If I have to stop all other treatments

18%  Possible side effects20%

 Length of study11%

Compensation5%

Have any of your healthcare providers ever suggested a clinical trial for a COPD medication?

Yes10%

No90%

Whose recommendation about a clinical trial would you respect the most?

Other (please be specific)7%

 Pharmacist1%

 What I see on TV shows like Oprah

0%

 The internet5%

A nurse0%

Pulmonologist61%

 One of my friends1%

 A previous trial participant

9%

 Family doctor (GP)16%

Have you previously participated in any type of clinical trial?

Yes16%

 No84%

 If you decided not to participate in a medication study, what would be your top 3 reasons?

Too difficult to travel to an appointment

9%

 Can not comply with the study requirements

6%

Too difficult for me to take medications

1%

Other (please be specific)

2%

 Did not want to get a placebo

18%

 Possibility of receiving a placebo

18%

Distance from study site was too far

26%

 Office hours did not work with our schedule

3%

 Too many visits were required for the study

8%

Not enough information about or afraid of side

effects19%

Which of the following do you think would be the most effective way to find COPD sufferers willing to participate in new medication study?

 Pharmacists or posters in a pharmacy

7%

Posters in grocery stores

1%

Announcements in local publications like The

Penny Saver1%

 Other (please be specific)

2%

 TV commercials11%

 Possibility of receiving a placebo

18%

 Internet (COPD-related websites)

31%

Posters or brochures at health clinics

4%

Email/newsletters from support groups

16%

Posters or brochures at doctor's office

16%

Would a dedicated COPD website for the families in the study keep you interested in participating?

Yes87%

No13%

Social Media COPD SURVEY RESULTS

DESTINATION

DEMOGRAPHICS

25-34 35-44 45-54 55-64 65+0%

10%

20%

30%

40%

50%

60%Age Range

71%

29%

Women

Men

SURVEY RESULTS

DESTINATION

Drive 2,500 ‘likes’ on Facebook.Spend less than $0.35/like.150 participants complete survey.

NOTE: Target audience for MyCOPDTeam will be the patient. age 45+, male & female, in Australia and North America.

SYMPTOMS EXPERIENCED

SURVEY RESULTS

DESTINATION

Drive 2,500 ‘likes’ on Facebook.Spend less than $0.35/like.150 participants complete survey.

NOTE: Target audience for MyCOPDTeam will be the patient. age 45+, male & female, in Australia and North America.

Sites’ Sources of Participants*Other

Referrals from physicians outside my practice

Self-directed patients from local outreach/advertising

Referrals from physicians within my practice

Current patient base

5%

9%

10%

15%

60%

*QuantiaMD January 2012: 524 PIs surveyed

Optimize sites

Optimize referral

networks

Raise community awareness

Recruitment Strategy Components

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

COPD Area RankingAll Patients Including Uninsured: “Heat Map” – Highest % Prevalence Is in Red

Source: Optum Clinformatics™ for Clinical Trials, Current Year

Highest Prevalence Is Tri Cities, KY - 11.3%72,934 Patients Out of 18+ Population of 643,554

Distribution of 9,194,284 COPD PatientsBy Gender and Age

Male; 44.0%

Female; 56.0%

Source: Optum Clinformatics™ for Clinical Trials, Current Year

Investigator

ReferringPhysician

ReferringAllied HealthProfessional

ReferringPhysician

Finding Referral Physicians

National physician lists show potential referring sites and their count of patients who match the protocol.

Our of the 1,119,000 individual physicians, we found 149,335 who see our patients.

Insurance claims can create a list.

One popular approach is to rank this list by both:• Patient Count• Mileage from Site (Hub)

Any x-mile radius

Source: Optum Clinformatics™ for Clinical Trials, Current Year

Hub and Spoke Report for Referrals

STRATEGIES

Posters

Brochures

Print/Radio Ad

Mail / Letters

Lunch ‘n Learns

Patient Database

Referrals

Support Groups

Customize Your Recruitment Plan

Your Enrollment Strategy:How will you do this and what help do you need?

1. Optimize your Site- What tools do you need- How will you effectively screen your database

2. Build Referral Networks- Where are potential participants who can’t afford their meds?- Who do you know who supports research

3. Build Study Awareness through Outreach- Where can you intersect potential Participants- What tools do you need to provide them- Do you have the manpower to go into the community