CULTURAL ADAPTATION

IN CLINICAL TRIALS

WHAT IS THE

PRIMARY GOAL?

Cultural adaptation is needed to improve

the quality of clinical research by

overcoming barriers among increasingly

diverse patient populations.

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.

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

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.

U.S. MINORITYHEALTH CARE

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...

Cervical cancer rates among

Vietnamese American women are

5x higher than those among the

general U.S. female population.

Although racial /ethnic minority

groups comprise one-third of the

U.S. population, they represent

67% of new AIDS cases.

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.

U.S. MINORITY

UNDER-REPRESENTATION

Minority underrepresentation in U.S.

clinical trials can be largely attributed

to language and cultural barriers.

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

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)

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:

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

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

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:

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:

TRANSLATION CHALLENGES

We have encountered several challenges

regarding translation for international clinical trials:

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 CHALLENGESLack of Unifying Standards

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

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

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

>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 / #

SPEAKERSOFFICIAL LANGUAGE(S)/

# OF SPEAKERSCOUNTRY

LANGUAGES OF INDIA & CHINA

In both instances,

minority languages are a

large % of those spoken

by the country's

population

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…

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

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

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

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.

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

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:

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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