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Cultural Adaptation in Clinical Trials


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

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Cultural Adaptation in Clinical Trials

  3. 3. Cultural adaptation is needed to improve the quality of clinical research by overcoming barriers among increasingly diverse patient populations.
  4. 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. 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. 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.
  8. 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. 9. Cervical cancer rates among Vietnamese American women are 5x higher than those among the general U.S. female population.
  10. 10. Although racial /ethnic minority groups comprise one-third of the U.S. population, they represent 67% of new AIDS cases.
  11. 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. 12. U.S. MINORITY UNDER-REPRESENTATION Minority underrepresentation in U.S. clinical trials can be largely attributed to language and cultural barriers.
  13. 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. 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. 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. 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:
  17. 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. 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. 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. 20. TRANSLATION CHALLENGES We have encountered several challenges regarding translation for international clinical trials:
  21. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
  34. 34. (877) 731-6332