As clinical trials expand internationally, so does the need for increased minority representation, document adaptation, and translation.

1. CULTURAL ADAPTATION
IN CLINICAL TRIALS

2. WHAT IS THE
PRIMARY GOAL?

3. Cultural adaptation is needed to improve
the quality of clinical research by
overcoming barriers among increasingly
diverse patient populations.

4. CURRENT CHALLENGES
FOR CLINICAL TRIALS
 Poor minority participation in U.S. clinical trials.
 Increased outsourcing of trials to emerging regions,
requiring more time spent on adapting patient
materials and trial processes.

5. MINORITIES IN U.S.
Minorities currently
comprise 1/3 of total
U.S. population
Current trends indicate
by 2050 they will
account for 2/3

6. U.S. DEMOGRAPHICS
Major Minority Groups
1. Hispanics (of any race)
2. African Americans
3. Asian Americans
The number of individuals under the age of 18 for Asian
and Hispanic ethnicities has been growing
exponentially.

7. U.S. MINORITY
HEALTH CARE

8. There are several issues regarding healthcare and
minority groups in the United States, mainly due to:
• lack of preventive care and treatment,
• underrepresentation in clinical trials.
The following statistics exemplify this...

9. Cervical cancer rates among
Vietnamese American women are
5x higher than those among the
general U.S. female population.

10. Although racial /ethnic minority
groups comprise one-third of the
U.S. population, they represent
67% of new AIDS cases.

11. Latina women have the third
highest breast cancer
mortality rate in the U.S., yet
they account for less than 2%
of clinical trial participants.

12. U.S. MINORITY
UNDER-REPRESENTATION
Minority underrepresentation in U.S.
clinical trials can be largely attributed
to language and cultural barriers.

13. The following have played a large role in these problems:
LANGUAGE AND CULTURAL
BARRIERS INCLUDE:
 Lack of sponsors from minority backgrounds
 Inadequate language services
 Insufficient community outreach programs
 Poor health education of minorities
 Poor public image of clinical research

14. WHICH LANGUAGES NEED
REPRESENTATION IN THE U.S.?
1
1.1
1.4
1.6
2
3
38
0 10 20 30 40
German
Korean
Vietnamese
Tagalog
French
Chinese
Spanish
The most spoken languages in the U.S. besides English:
1
1.1
1.4
1.6
2
3
38
0 10 20 30 40
German
Korean
Vietnamese
Tagalog
French
Chinese
Spanish
The most spoken languages in the U.S. besides English:
Approx. #
of speakers
(millions)

15. OUTSOURCING TRENDS
 High cost of drug development
 Low recruitment rates
 Requirement for greater genetic diversity among
patient populations
The following have played a large role in industry trends
and are reasons for outsourcing clinical trials:

16. PATIENTS ENROLLED IN
U.S. CLINICAL TRIALS
57% of patients registered for clinical
trials in 2017 were from outside the U.S.
57%
38%
5%
Patients outside the U.S.
Patients inside the U.S.
Both U.S. and non-U.S.
Source: ClinicalTrials.gov

17.  The largest number of overseas participants were
from Western Europe.
 Asia is the most common location for clinical
studies requiring large patient #s (China & India).
 Other dominant emerging regions included:
South America i.e. Brazil, Russia & the Middle
East.
PATIENTS ENROLLED IN
U.S. CLINICAL TRIALS

18. OUTSOURCING CHALLENGES
 Country-specific requirements
 Linguistic diversity
 Cultural barriers
 Accepted medical practices
 Poverty and illiteracy in patient populations
Despite many advantages to outsourcing clinical trials,
there are challenges that must be overcome:

19. TRANSLATION REQUIREMENTS
 Documents for regulatory authorities must be provided in the
country’s official language.
 Patient-related materials must be provided in patient’s native
language(s) which may not be the same as the official language.
 Informed consent forms must be culturally adapted & provided
in simple language.
 Patient questionnaires & reports must be linguistically
validated & culturally adapted.
Companies conducting international clinical trials must
meet certain translation requirements. These include:

20. TRANSLATION CHALLENGES
We have encountered several challenges
regarding translation for international clinical trials:

21. Grammar and spelling varies
across each of these languages.
Common Indian Languages
 Hindi
 Punjabi
 Marathi
 Malayalam
 Telugu
 Kannada
 Gujarati
There are often fluctuating standards in grammar and spelling across
languages and dialects. This is common in countries where there are
multiple languages that aren’t often translated i.e. India
TRANSLATION CHALLENGES
Lack of Unifying Standards

22. Linguistic Variation
 Castilian Spanish vs. Mexican Spanish
 50+ different Mexican dialects from
Yucatan to Mexico City
 Largely due to borrowed words from
indigenous languages i.e. Mayan,
Nahuatl, Mixteco, Zapoteco
For example, each Latin
American country has
different spoken
variations, including
variations of dialects.
TRANSLATION CHALLENGES

23. Identifying Language Equivalents
Mandarin Chinese
 Chinese uses characters not letters and has two
sets of characters: traditional and simplified.
 Written Chinese does not use initials or
abbreviations.
 One Chinese character can represent multiple
grammatical forms:
‘treat’,
‘treating’,
‘treatment’ - 3 English words, 1 Chinese character.
Identifying language equivalents between unrelated
languages, i.e English to Mandarin Chinese, is difficult
due to differences in structure and grammar.
TRANSLATION CHALLENGES

24. Proficiency in Official Language
 Multiple official/national languages
 Dominant minority languages
 Limited access to education and low
socio-economic status
In most cases documents must be translated into the
official language of the country. However in some
countries there are:
These variables present a problem for many populations because
people are not proficient in their countries' official language(s).
TRANSLATION CHALLENGES

25. >12 official languages recognized
at the national level and even more
at the regional
100’s of spoken languages/dialects
40 million
337million
41 million
33 million
30 million
28 million
23 million
53 million
66 million
63 million
70 million
43 million
English
Hindi
Gujarati
Kannada
Malayalam
Oriya
Punjabi
Tamil
Telugu
Marathi
Bengali
Urdu
India
70 million
25 million
50 million
90 million
77 million
40 million
Cantonese
Xiang
Min
Shanghainese
Hokkien
Hakka
Over 700
million
Mandarin ChineseChina
OTHER MINORITY LANGUAGES / #
SPEAKERS
OFFICIAL LANGUAGE(S)/
# OF SPEAKERS
COUNTRY
LANGUAGES OF INDIA & CHINA
In both instances,
minority languages are a
large % of those spoken
by the country's
population

26. CULTURAL CHALLENGES
 Culture determines a patient’s
perception and bias to treatments
and disease.
 Customs or religious practices
may affect when and how a clinical
trial is conducted.
 Accepted medical practices may
differ from those in countries where
clinical research is well established.
In addition to linguistic challenges…

27. Patient Cultural Biases: Pain
 Pain perception is largely dependent on culture.
 Some cultures under-report pain - they may
accept it as part of the disease or a show of
strength.
 Lack of standardization can affect trial data if
this is not taken into account.
CULTURAL CHALLENGES

28. Some countries have unique practices that
must be considered before conducting trials.
For instance, in Islamic countries during
Ramadan a majority of the population will be
fasting, which can affect outcomes of the trial.
Customs & Religious Practices
CULTURAL CHALLENGES

29.  Patient/physician relationships in many cultures are ones
of trust and respect. Recommendations by physicians to
participate in clinical trials largely account for patient
enrollment in many countries, but must be considered for the
effect on informed consent.
 Roles of gender and age in making medical decisions.
 Role of family in making medical decisions.
 Partial disclosure practices are common in many
countries Many times the full diagnosis and risk related
factors are given to families, not patients.
Culture can impact which medical practices are acceptable.
Culture & Medical Practices
CULTURAL CHALLENGES

30. EFFECTIVE COMMUNICATION
The importance of effective communication between
sponsors, investigators, and patients cannot be
underestimated.
Ineffective communication can impact the process of
gaining ethical informed consent and data accuracy.

31. 1. Use a professional translator
2. Translator must be a native speaker
3. Translator must be familiar with cultural
aspects that can impact study
4. Translator must have a background in clinical
research or health care
5. Translator must use well-established methods
and follow proven guidelines
TRANSLATION GUIDELINES

32. RECOMMENDATIONS
 Identify target patient population & local regulatory requirements.
 Communicate expectations to investigators taking cultural
differences into account.
 Address cultural factors that may affect patient reporting of data.
 Implement methods to overcome barriers for patients with limited
reading comprehension.
 Employ experienced translation and localization experts.
We must act to overcome linguistic and cultural barriers in
order to increase the effectiveness and enrollment of
international and U.S. clinical trials. To do so, we recommend:

33. CONCLUSIONS
 Clinical research is strongly impacted by
linguistic, cultural, and socio-economic
barriers among diverse patient populations.
 These barriers must be properly addressed in
order to conduct ethical and quality clinical
research.

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