Global Issues in Patient Recruitment and

Retention: Challenges and Solutions

Patient Recruitment Workshop

Mumbai, India
November 3rd, 2008
 Agenda & Objectives

 Welcome & Introductions

 Understand Motivations for Clinical Trial
Participation
 Describe Key Recruitment Challenges
within India
 From Challenges to Solutions – Best
Practice Sharing
 The Bottom Line

• Overwhelming need for organized recruitment strategies

in India
– To educate potential patients
– To remove barriers to trial participation
– To remove logistical barriers
– To ease burden on CRC

Large patient pool High # of participants

 Understanding
Patient Motivators

“There are things known and there

are things unknown, and in between
are the doors of perception.”

-Aldous Huxley
 Patient Motivations

• Before we understand how to reach a

participant, we need to understand WHO
they are-
• The core of successful recruitment is understanding what
motivates the individual to participate…
• How does the patient think, feel, and react to their
particular health need
 Reasons people volunteer
for clinical trials
 Not adequately treated with current therapy
 To seek new treatments
 To help future generations
 To get study-related treatment at no cost if they do
not have insurance or financial resources
 To respond positively to their physician’s request
to participate
 To seek attention from physicians and staff
 Compensation

*Spilker, 1992 (Synopsis)

 Reasons for Study Participation

  2001 2003
To advance medicine / science 55 % 54 %
To help others with the condition 47 % 46 %
To earn extra money 51 % 42 %
To obtain better treatment for your condition 56 % 40 %
Education about treatment / improving your health 33 % 37 %
Based on information read, seen or heard about the
study 28 % 36 %
Doctor recommended the study 24 % 25 %
Curiosity about study / medical practice 29 % 23 %
To obtain free medication 25 % 24 %
Had a life-threatening illness 16 % 5%

Source: Harris Interactive - "The Will and Why Survey"

Motivation is Not as Simple as This List
Leads Us to Believe

• Psychology of why people enroll in a clinical

trial is complex

• Statements are often collected in a simple

questionnaire which does not account for more
than one factor in play

• We get an incomplete picture because we don’t

understand the individuals better
What Do We Really Want to Know?

• On a deeper level, what are the true

reasons people participate in a trial?
• Who actually influences their decision to
participate in a trial?
• How does perception affect someone’s
willingness to participate in a trial? Or are
there other more important factors?
• Why do qualified people ultimately not
participate?
 How Did the Answers Compare?
The limits of one-dimensional data (example)
Open-ended question Probing question

Advance medicine/science and help others Advance science, help future generations 3%
45%

Learn more about my disease 25% Learn more about my disease 6%

Try new med, see if it works better for me 20% Try new med, see if it works better for me 52%

Obtain treatment for disease at no cost 10% Obtain study-related treatment at no cost
6%

*33% Other
 What Did We Learn?

• People tell us what they believe at the time, (“I’m doing this for
future generations”) but that isn’t always the complete truth

• The limits of one-dimensional data; it’s just a snap shot

• Even cross-tabulating with demographic information age,

income, education, etc. leaves big gaps in our
understanding of who our target audience is and the
barriers we need to overcome

• Demographics and one-dimensional data don’t answer the

questions of motivation or willingness

 Healthy Mom takes hungry kids to McDonald’s - in spite of her

insistence that she cares about health and nutrition
 Attitudes and Needs
• We are looking beyond self-reporting,
beyond demographics to understand
our target audiences
• Attitudinal data gives a deeper look as
to what people think and believe
• Needs are foundational pieces of data
that can override or reinforce attitudes

Attitudes + Needs = Why

Attitudinal Segmentation Model™

One-dimensional data
is conflicting

Current generic
psychographic data
is too broad
 ™
Attitudinal Segmentation Model

• This model reflects a hypothesis based on

observational data and experience
• Six primary attitudinal segments have been
identified and are of most interest to our
recruitment efforts
• CISCRP – Center for Information Study on
Clinical Research Participation
 Attitudinal Segments
Content
Physician
&
Followers
Accepting

Scared
Financially Recruitment
&
Frightened Challenges Seeking

Latest
Greatest Nothing to Lose
Seekers
 Understanding Attitudinal Segments

• Understanding motivations and needs will provide

a clearer focus as to how we approach
consumers about clinical trials with specific
messages
• Market is huge, but not for a given study, so
segmentation will help us maximize participation
from the target population
• Provide a more efficient use of recruitment
dollars
 Physician Followers Physician
Followers

• Highly influenced by physician’s recommendation or

endorsement
• May be the physician’s own trial, or brought by the patient
• Extremely strong motivator
• Not gender-specific, age-related, or related to
severity of disease
• Slight trend toward less educated
• Implication: Improve communication with physician
community
INDIA
15% participate because
“my doctor advised me
to participate”
Source: 2008 Excel Life Sciences Informed Consent and Volunteer Experience
 Who Helped You Make the Decision to
Participate?

INDIA
100%
17% Made Alone Made With Input 31% - Spouse
75% 21% - Parents

50%
83%
Source: 2008 ELS IC and Volunteer Experience

25%
30% 30%
24%
9% 7%
0%
Total Personal Family Other Study Friend
Doctor Member Nurse

Source: 2002 CenterWatch Survey of 1,561 Study Volunteers

 Scared and Seeking Scared
&
Seeking

• Newly diagnosed
• Long-term disabling or life-threatening disease
• Motivated to drive further, wait longer
• Highly responsive
• Implication: Communicate regularly with
diagnostic centers
 Nothing to Lose Nothing to Lose

• More advanced stages of their disease

• Typically older
• Have exhausted their treatment options
• Not getting positive results
• Looking for hope
• Helping future generations can be a
deciding factor
• Implication: May not tolerate being in a placebo
group
 Latest
Latest Greatest Seekers Greatest
Seekers

• Advocates for their own health

• Well-educated and reasonably affluent
• Typically have family history of concern or in a high-
risk group
• Main motivator is prevention
• High cost of leading-edge tests and treatment is a
factor
• Implication: Attracted to cutting edge technology
and treatment
INDIA
15% participate “to
find better treatment”
Source: 2008 Excel Life Sciences Informed Consent and Volunteer Experience
 Financially Frightened Financially
Frightened

• The only segment highly motivated by free tests and

care
• Typically uninsured or believe themselves
to be underinsured
• Remuneration is not the motivator
• Motivator is fear of the high cost as disease
progresses
• Implication: Long-term study could be of interest
INDIA
Only 5% participate “to receive money”
Compared to ~40% in US
Source: 2008 Excel Life Sciences Informed Consent and Volunteer Experience
 Content and Accepting Content
&
Accepting

• Current medical treatment is working

• Very risk-averse segment
• Change many not mean gain to them
• Physician might have influence, but
no guarantee
• Implication: May not justify spending a great deal
of time and focus trying to recruit
 Attitudinal Segmentation May Help Us
Learn What We Really Want to Know
• Future recruitment for trial participation will be based on
segmentation: example, the target for digital
mammography may be the same age woman as
rheumatoid arthritis, but she
is not the same and will not respond in the same way
• We believe that factors, such as perception, that
significantly reduce someone’s willingness to participate
in a trial may be different by segment
 Application to Open Studies

• GROUP EXERCISE:
– What is the primary motivator for your
patients in general?
– Are there any attitude segments that you feel
best describe your patient population?
– How do you appeal to this level of motivation
– Please discuss as a group and be prepared to
share your conclusions
 Recruitment
Challenges in India
 Recruitment
Challenges
Identify the Challenges
Take 10 minutes and work in small groups to
identify as many recruitment challenges or
barriers as you can. Write each challenge on a
separate note card.
 Understanding Recruitment Challenges

Awareness Logistical

Literacy
Recruitment
Other Emotional
Challenges

Educational Cultural Communication

 Recruitment Challenges - LOGISTICS
• Logistical Barriers
– Transportation
– Travel
– Refrigeration
 Recruitment Challenges - CULTURE
• Cultural Barriers Religion Population Percent   
– Religious holidays All religions 1,228,610,328 100.00%
– Family involvement Hindus 867,578,868 82.456%
– Females unwilling Muslims 158,188,240 10.934%
to drive Christians 24,080,016 2.141%
– Females of Sikhs 19,215,730 1.868%
childbearing Buddhists 16,947,992 1.704%
potential Jains 4,225,053 0.91%
Others 6,639,626 0.645%
Religion not 727,588 0.07%
stated

Source: http://en.wikipedia.org/wiki/Religion_in_India
 Recruitment Challenges - CULTURE

• Communication Barriers
– High number of dialects
– ICF translations

• 216 languages spoken

by groups of 10K people

• 415 total living languages

 Recruitment Challenges - LITERACY
• Literacy Concerns
– Informed consent
process
“Among the factors that may explain the poor
learning achievement…overcrowded
classrooms (with primary pupil/teacher ratios
above 40:1 in India)”

“In countries where overall literacy rates

are comparatively low, urban/rural
disparities are also large: for example,
44% rural vs 72% urban in Pakistan.”

Source: UNESCO: Education For All: Global monitoring report 2008

The Good News…

• Drastic improvements
in literacy rates from
1981 to 2001
• This continues to
improve

Source: http://en.wikipedia.org/wiki/Image:Literacy_Bar_Chart.jpg
 Recruitment Challenges - EDUCATION
• Educational Issues
– Clinical Research
Coordinators
– Principal
Investigators
– Patients The education available is
– Families not keeping up with the
demand.

~10 Academies/Institutions
offering education in clinical
research
 Recruitment Challenges - AWARENESS
• Patient Awareness
– Lack of awareness
– Skepticism
• Media Concerns
– Public Perceptions
– Patient Perceptions
– Right to
Information Act of
2005
The Right to Information Act 2005 is a law enacted by
the Parliament of India giving citizens of India access
to records of the Central Government and State
Governments. The Act applies to all States and Union
Territories of India, except the State of Jammu and
Kashmir - which is covered under a State-level law.
Under the provisions of the Act, any citizen (including
the citizens within J&K) may request information
from a "public authority" (a body of Government or
"instrumentality of State") which is required to reply
expeditiously or within thirty days. The Act also
requires every public authority to computerise their
records for wide dissemination and to proactively publish
certain categories of information so that the citizens need
minimum recourse to request for information formally.
http://persmin.nic.in/RTI/WelcomeRTI.htm

INDIA –
Prior to participation in a study:
• 56% of subjects were Not • 38% Aware
Aware of clinical research • 6% Very Aware
Source: 2008 ELS IC and Volunteer Experience
From Challenges to
Solutions
 Understanding Patient Sources

• Development of successful recruitment

strategies requires an understand of the
potential sources of trial participants

• Understanding this helps develop

targeted recruitment strategies

• If you have a target, you know where to aim!

 Three Primary Sources

• Three Primary Sources of Patients

– Within the investigator’s practice
– Within the physician community
(patient referrals)
– Within the public at large
 The Practice

• Previously seen patients located through chart

review
• New patients
• Instant access to potential patients
• First source to be exhausted
 The Physician Community

• Physician referrals
• Referrals from other healthcare providers
• Usually the 2nd patient source
• Doesn’t happen without a sense of
awareness about the study

INDIA – New data

 76% of trial volunteers - PCP is PI
 21% of trial volunteers - referred by PCP
Source: 2008 ELS IC and Volunteer Experience
Physician Referrals – US Data
 The Public at Large

• General public
• Diagnosed and undiagnosed patients
• Treated and untreated patients
• Usually the 3rd patient source

INDIA – New data

 3% of volunteers learned of study through
PRINT, TV, RADIO, FRIENDS, FAMILY
Source: 2008 ELS IC and Volunteer Experience
How European Patients Learn About
Clinical Trials

75%

Doctor or Nurse
16%
Family or Friend
Clinical Study Staff
5%
Media

5%

0% 25% 50% 75% 100%

Source: CenterWatch, 2000

 Breaking Down the Barriers

Step 1: Identify the Challenges

Step 2: Determine whether each “Recruitment

Challenge” is controllable or non-controllable

Step 3: Develop strategies to mitigate the effects

of the recruitment challenges and barriers
Controllable vs. Non-Controllable

Controllable Non-Controllable

• Logistical • Medical / Safety

• Physical • Life Changing Events
• Educational /Emotional (e.g., moving, lost job)
• Influencers
Controllable vs. Non-Controllable

Take a few moments and group your note

cards into these two categories.
 Breaking Down the Barriers

Step 1: Identify the Challenges

Step 2: Determine whether each “Recruitment

Challenge” is controllable or non-controllable

Step 3: Develop strategies to overcome

recruitment challenges and improve your site’s
recruitment success
Developing a Recruitment Plan
 Case Study

 Global Recruitment Program

330 Sites (20 in India)
Multiple Sclerosis
8 patients/site
6 month enrollment period
3 year study duration
 Challenges:
Difficult Inclusion/Exclusion Criteria
 Actual Program
 Relapsing-Remitting MS
 ~400 sites worldwide
 39 countries
 2500 patients
 Enrollment - 20 months
 27 sites in India
Recruitment Program Components

 Recruitment Materials
 Physician Outreach
Materials
 Physician Letter
 I/E Cards
 Patient Brochure
 Posters
 Fliers
 Patient Brochures
 Community Event
Calendars
 Print Ad
Recruitment Program Components

 Site Support Materials

 Pocket Protocols
 Treatment Flow Charts
 Screening Tools
 Team Website
 CRC Teleconferences
 Key Takeaways

 Large patient populations don’t necessarily = high numbers of

trial volunteers

 There are many barriers and challenges related to patient

recruitment which can undermine the success of your site

 By evaluating each challenge, you can develop a strategy to

mitigate the impact on enrollment within your site

 Always take legal and ethical concerns into consideration

when reaching out to potential trial volunteers
Thank You