Download - Needham Recruitment
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