2. 3
table of
INTRODUCTION
PATIENT RECRUITMENT IS AT THE CENTER OF TRIAL DELAYS
RECRUITMENT COMMUNICATION IS PAINFUL
DRIVING LOCAL RELEVANCE
CASE STUDY: THE IMPACT OF DELAYS
CONCLUSION
4
6
12
20
26
30
CONTENTS
3. 54
introduction
Despite challenges surrounding increased regulations and evolving clinical
standards, conducting clinical trials globally is an attractive option for life
sciences organizations. Rising development costs along with the expanding
volume and protocols of clinical trials have prompted sponsors to work with
international investigators and global patient populations.
• Leading emerging countries will account for 28% of global spending on
pharmaceuticals by 2015, as compared to 12% in 20051
• The number of active investigators in the US has declined 3.5% annually
since 2001, whereas active investigators outside the US has increased
13.5% each year during that same period2
• Annual growth in non-US based investigators is decelerating due to a
number of factors including diminishing economic advantages and global
regulatory constraints2
• As rare diseases studies increase and chronic illnesses such as diabetes,
heart disease, and cancer continue to grow, global trials open up new
patient pools. Communication in clinical trials must evolve to meet the
demands of the changing clinical landscape, with patient recruitment and
retention communications at the forefront
In this eBook, we break down the challenges surrounding successful
implementation of global patient recruitment and retention, and provide
ways to ensure optimal results from a communications perspective.
GLOBAL CLINICAL TRIALS GROWTH:
A VIEW FROM THE TOP
LET’S GET STARTED!
1
The Pharmaceutical Industry and Global Health: Facts and Figures, 2011, IFPMA 2
Getz, Zuckerman
and Rochon, ‘Landscape changes highlight growing challenges for clinical research sponsors’ 2009
4. 6
The landscape of global clinical trials can be
rough and rocky due to delays that cause
a rippling effect. Delays can cause a trial
sponsor to lose millions of dollars by having
to extend study timelines — subsequently
delaying the drug’s regulatory clearance and
greatly impacting sales.
ROUGH
AND ROCKY
TERRAIN
NEARLY 80%
85% UP TO 50%
of clinical trials
fail to finish
on time3
of clinical trials
fail to retain
enough patients3
of sites enroll
one or no patients
in their studies3
AND THE LIST GOES ON!
Examples of the kinds of delays that contribute
to a challenging clinical trial landscape include:
• Patient recruitment delays
• Study start-up delays
• Study investigational product
availability delays
• Translation delays
• Recruitment material creation and
distribution delays
• Protocol amendment
PATIENT
RECRUITMENT
IS CHANGING
3
Recruitment Roles Applied Clinical Trials, Sept. 2011
5. 8
A COSTLY EFFORT
The effort to recruit patients into clinical trials is often
considered as challenging as drug discovery itself.
Changes in study designs are the greatest issue
impacting the recruitment process. Studies today
are twice as long as compared to studies completed
a decade ago, and now require a larger number of
patients.4
Protocols are more complex in both the
amount and type of procedures required.
• The delays in patient recruitment for clinical trials
account for an average of 4.6 months lost per trial5
• Each day a drug is delayed from market, sponsors
lose up to $8 million5
• Eighty percent of total trials are delayed at least
one month because of unfulfilled enrollment6
4
Accelerate Time to Revenue with Less Risk and Cost Using the Medidata
Clinical Cloud, Medidata Solutions, Inc. 2013 5
Beasely, “Recruiting,” 2006.
6
Lamberti, “State of Clinical Trials Industry”, 292
6. 10
CONSIDER
COMMUNICATIONS
FOR THE GLOBAL AGE
More and more, digital, mobile, and social media are becoming
integrated elements of patient communications strategies. Social
media, in particular, has been gaining ground in patient recruitment
campaigns because of its immediacy, two-way dialogue, and
customization capabilities.
• Patients are going to social media to learn and communicate
about their health
• Many countries have multiple popular social media outlets that
can be utilized effectively to drive patient recruitment
• A report from Pew Research Center indicates that Egypt,
Russia, the Philippines and 14 other countries outpace the U.S.
in the proportion of internet users using social sites.7
DO’S AND DON’TS IN A GLOBAL CONTEXT:
• Do not alienate the target audience with an overly “English”
centric tone in communication
• Do consider the cultural differences and challenges in order
to recruit effectively globally
• Do execute differently based on each country’s communication
method preferences
11
With the goal to recruit more specific patient populations
intensifying as the specificity of trial protocols increase,
creative ways to recruit and retain the right patients for a
trial’s target indication are important.
The traditional patient recruitment communication
methods have been consistent for the last decade,
and largely remain effective for certain types of studies.
The methods of recruitment communication have been:
• Phone
• E-mail
• Printed materials
• Traditional advertising (T.V., radio, newspaper)
• Websites
Retaining study participants is just as important as
enrolling them into a study. In order to retain a study
participant, frequent and meaningful communication
is needed. Retention communications can be delivered
in a variety of ways such as:
• Visit reminder cards
• Thank you cards
• SMS text messages
• Study appreciation items
Each communication method requires tailoring, and
if executed incorrectly, could be detrimental to the
success of patient recruitment and retention.
COMMUNICATIONS
NEED TO BE
CONTINUOUSLY
EVALUATED
7
Livescience: 17 Developing Countries that Love Social Media More Than
US. Feb. 13, 2014
7. 1312
RECRUITMENT
COMMUNICATION
IS PAINFUL
THE BIG MYTH:
Everyone who works on a clinical trial speaks and/
or reads U.S. English. This is the farthest from the
truth, and is evident in in-country communication
between Sponsors, CROs and Sites. Often, global
patient recruitment and retention materials created
in the U.S. overlook the impact of language and
translation and its ultimate effect on the trial.
Something as simple as the word “you” — if not
formalized correctly — can be interpreted as rude
and offensive in some cultures. When considering
global communication, remember that the official
language is not the only language.
A LOT CAN GET LOST
IN TRANSLATION IF THE
APPROPRIATE RESOURCES
AREN’T USED!
GLOBAL
LANGUAGES:
WHAT WORKS FOR
ONE WON’T WORK
FOR ALL
8. 14
It is common practice for Sites and CROs to have project teams
based in different countries. If the Sponsor is based in Asia and
the CRO is based in the U.S., for example, communication can
be extremely difficult because as one country is completing their
workday, the other country may not have started theirs yet.
• Is your team aware of time zone differences?
• Is your team sensitive to time zone differences?
• Does your plan and strategy work around the
time zone challenge?
TIME ZONE
CHALLENGE:
COMMUNICATIONS
ON A GLOBAL SCALE
(AND CLOCK)
9. 1716
EVERY CULTURE
IS DIFFERENT
AND REQUIRES
DIFFERENT
COMMUNICATIONS
The diversity of cultures participating in global
clinical trials requires sensitivity as to how
communications are developed. Words and
images need to be carefully reviewed for relevance
and understanding within each targeted patient
recruitment population. From a patient retention
perspective, culture and language differences may
generate miscommunication of critical health care
instructions, or encourage a lack of compliance
with protocols, or could prompt other responses
that may negatively influence patient safety and
the trial’s success.
When communicating, it is important to consider
your audience.
• This is true for spoken, written and
visual communications
• Colors, imagery, slang and informal speech
can be offensive
• Customs also play a role in global communication
LANGUAGE SELECTION
The number of languages selected to be translated in a patient
recruitment program is often minimal, with only one or two
languages utilized per country. This decision can limit the patient
population significantly by reducing the number of potential
patients who can access the study information. Global languages
by region are multiple. In North America, for example, English and
Spanish are predominant, yet French and Chinese are also very
prominent. Potential patients could be excluded if a complete
list of languages is not developed and agreed to in the initial
recruitment planning stages.
• What options are available for patient populations that may
want to participate but cannot, because the study does not
include information in their language?
• How is the study message relayed to the community
if the recruitment materials are not available in all languages
spoken and read?
• When is language considered?
IMPORTANCE
OF TRANSLATION
QUANTITY
AND QUALITY
10. 1918
most common languages
GLOBALLY
English
Spanish
French
Chinese
Other
70%
9%
3%
1%
17%
NORTH AMERICA
Spanish
Portuguese
Creole
English
Other
58%
33%
2%
1%
6%
LATIN AMERICA
Arabic
Swahili
French
English
Kwa
Hausa
Other
17%
8%
6%
4%
4%
3%
58%
AFRICA
Russian
German
Turkish
English
Italian
French
Polish
Spanish
Ukrainian
Other
22%
12%
9%
8%
8%
8%
6%
6%
4%
17%
EUROPE
Chinese
Hindustani
Bengali
Indonesian
Japanese
Punjabi
Other
34%
12%
8%
6%
3%
3%
34%
ASIA & PACIFIC
Babla.com
11. 2120
DRIVING LOCAL
RELEVANCE
IMPORTANCE
OF QUALITY
TRANSLATIONS
SINGLE SOURCE PROVIDER
Communications created with a Western bias cannot
succeed in different cultures when recruiting and
retaining patients in global clinical trials. Initiatives
undertaken with insufficient knowledge of local
cultures and languages create recruitment delays
and trigger losses in revenue. Poorly or inaccurately
translated materials could lead to severe clinical
consequences, putting patients at risk.
A way to ensure that quality translations are
provided on a consistent global basis is to source
a single translation resource with a comprehensive
understanding of the life science marketplace and a
global footprint to provide on-the-ground support.
This minimizes the chances of error, eliminates
learning curves, and speeds the process. Quality is
paramount! Centralizing translation and localization
with one provider improves consistency and quality.
More often than not, language translation is the
smallest line item in any global clinical trial or
regulatory effort, but improper translations have a
profound effect on the success of a clinical trial.
Partrnering with an LSP with a wide global footprint
and east-to-integrate technologies that safely and
convenientyly enable the sharing and re-use of
translated content from prior studies helps assure
trials with favorable outcomes.
12. Face to Face Interpretation
In person interpretation for hospitals,
small meetings, cultural diversity training,
court hearings.
CLINICAL SITE COMMUNICATIONS
When vital information has to cross language
barriers in real time, there’s no room for error.
Assisting clinical sites with interpretation services
allows for more accurate communication to
patients, caregivers, administrators and trial
sponsors for an enhanced communications
continuum.
Interpreters can be available to assist with site
visits, site recruitment plan calls, or any other
time assistance is needed with interpretation.
Two forms of interpretation are used:
• It is important to be able to seek a resource
that has expertise in a multitude of languages
to ensure that language is not an impediment.
• Be certain interpreters are carefully screened
and selected to deliver the highest quality
language interpretation services.
• Make sure they are thoroughly trained and
tested on their knowledge of protocol and ethics
before they enter the site.
• Work with a provider that can source onsite
interpretation services quickly, and as close to
your site as possible in order to reduce travel
costs and time delays.
Over the Phone Interpretation
24/7 on-demand and scheduled calls for
hospitals, federal clients, call centers, and
customer support.
TRANSCREATION
With so much at stake, sponsors are moving past current
standards of culturally inflected translation to a higher
level of quality in which the meaning, emotion and intent
of a given sentence is rendered. By transcreating materials,
the new standard is creative marketing that bridges the gap
between translation and comprehension in regions with different
attitudes toward diseases and therapies.
Examples of content ideal for Transcreation include:
• Tag Lines
• Multimedia Campaigns (Digital, Print, Online TV, Radio)
• Brand messaging
• Overview brochures and instructional guides
• Web copy
A good rule of thumb to follow is that transcreation should be
used when the success of the communication relies
on an essential voice and style that must be maintained
in another language or culture.
TRANSCREATION IS THE KEY TO
GLOBALLY CONSISTENT, LOCALLY
IMPACTFUL BRAND EXPERIENCES
With some trials taking place in as many as 30 different markets, it
is critical for translated instruments to be conceptually equivalent
to the original content and to all of the other language versions.
22
13. 2524
WHAT TO LOOK FOR WHEN TAPPING AN
EXPERT GLOBAL RESOURCE
A resource that has a proven track record in providing quality
translation services, capabilities in cultural adaptation for both
online and offline communications, and access to worldwide
markets will create efficiencies for your organization, and will
support your success across global patient recruitment and
retention communications.
THE EFFECT OF
POOR TRANSLATIONS
LOCAL MARKET
KNOWLEDGE
REGULATORY
PARAMETERS
CULTURAL
ACUMEN
MARKET
ACCESS
PATIENT
RETENTION
preferred delivery
methods, profile
of country’s
healthcare
infrastructure.
permissible/not
permissible tactics,
patient timing for
study entry.
socially-accepted
tactics, best way to
convey images and
messages
measuring
country feasibility,
sourcing a
translation
specialist, study
scale-up.
strong rates,
comprehensive
project
management.
POOR TRANSLATION
SPONSOR
LEVEL
CRO LEVEL SITE LEVEL
Loss in
revenue,
inaccurate
study data,
longer time
to market.
Missed
timelines,
budget issues,
loss of trust
from Sponsor
and Sites.
Difficulty
communicating
study message,
potential
harm to study
participants.
14. 26
case study:
THE IMPACT
OF A DELAY
• Global infertility study recruiting in Canada,
US, Argentina, Chile, Brazil, Belgium,
Netherlands, Spain, United Kingdom,
and Hungary.
• Enrollment was one year with standard
recruitment materials as the main form of
recruitment tools.
• Participants only had to agree to allow
sites to collect unused study samples,
no investigational product was given and
no study visits were required.
• Enrollment was behind and the sponsor
was dissatisfied with the CRO’s
recruitment assistance.
• The CRO reexamined why enrollment
was behind and implemented site-specific
recruitment plans which involved asking
each site why enrollment was behind and
what needed to change.
• All sites agreed that the recruitment
materials needed to be revised, as
the participants could not relate to
the study message.
BACKGROUND:
ISSUE:
TIMELY PATIENT
RECRUITMENT
HINGES ON EFFECTIVE
COMMUNICATIONS
15. 28
• Infertility, a difficult and stressful medical
condition, did not evoke images of women
walking on the beach and through the park.
• The established study identity was
inappropriate and not representative of
the medical condition or patient population.
• A new identity and message set was
developed to identify with those in the
emotional state of not being able to
achieve pregnancy.
RESOLUTION:
RESULT:
• Communication between the CRO, Sponsor
and Sites and enrollment rapidly improved.
• Enrollment increased so dramatically that
the enrollment targets were exceeded and
enrollment ended six months early.
THE TAKEAWAY
Communication matters
through all levels in
patient recruitment and
retention. Talking to the
Study Coordinators and
hearing feedback from the
study participants ensured
relevant and relatable
patient communications.
29
16. 3130
HOW CAN LIONBRIDGE
LIFE SCIENCES HELP?
Recognized by Forbes as one of the most trustworthy companies
in America, Lionbridge Life Sciences works with some of the largest
pharmaceutical and clinical research organizations supporting
their global clinical trial activities, many with thousands of patient
participants in numerous countries per trial.
With Lionbridge, you have access to a highly-specialized network
of linguists and translators who have extensive medical and scientific
training and experience. Our centralized approach to translation
coupled with our global project management methodology ensures
consistency and quality across languages, while reducing the total
time it takes to adapt and translate patient recruitment and retention
support materials.
Lionbridge Life Sciences is a specialized business unit within Lionbridge,
providing medically trained linguists in more than 40 full-service solution
centers in 26 countries. We work exclusively with Pharmaceutical,
Medical Device and Clinical Research Organizations to maximize
global communication effectiveness within the boundaries of a highly
regulated, complex and always-challenging life science environment.
http://lifesciences.lionbridge.com/
conclusion
This e-book was adapted from the Lionbridge Life Sciences Webinar, Achieving Greater Impact in
Global Patient Recruitment and Retention Communications.
Special acknowledgment to the Author, Nicole Vives, Clinical Resourcing Manager, Lionbridge Life
Sciences, and Moderator, David Palmer, Business Development Director, Lionbridge Life Sciences.
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