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So You’re Not a Doctor:
 Taking the Plunge into Medial
    Translation without an MD
Quiz review: Question 1

   In “Administer 300 IU/kg of body weight,”
   “IU” means:
        A.   Iodine Unit
        B.   5-Iodouracil
        C.   International Unit
        D.   Intrauterine




Quiz
Quiz review: Question 2

   Which of these does not belong?
        A. Anjina (TR)
        B.          (RU)
        C. Angina (EN)
        D. Angine (FR)




Quiz
Quiz review: Question 3

   The largest therapeutic category for drug
   development is:
        A.   Central Nervous System
        B.   Infections (HIV, Hepatitis, etc.)
        C.   Autoimmune & Inflammatory Diseases
        D.   Cancer




Quiz
Quiz review: Question 4

   Which of the following is an invasive procedure?
        A.   Stress Echocardiography
        B.   Transesophageal Echocardiogram
        C.   Plain Abdominal X-ray
        D.   Transthoracic Echocardiogram




Quiz
Quiz review: Question 5

   Which of the following is not a national
   regulatory body?
        A.   FDA
        B.   AFSSAPS
        C.   AQuMed
        D.   Health Canada




Quiz
Presentation overview

  1   Introduction & background


  2   Challenges & barriers to entry


  3   Getting it right


  4   A closer look

  5   Resources & standards
1. Introduction & background
Industry overview: Fast facts
                                                  Growth industry

  2011 pharma sales > $880 bn

                                               Regulatory opportunities
  It takes the FDA an average
  of 16 months to approve a
  new product
                                Expanding geographic/linguistic requirements

    25-27% growth in top 17
    “pharmerging” countries

                                       Sustained growth/aggressive vertical
   Average cost to bring to
   market = $500 mn;
   Average product life cycle
   = 10 years
1- Introduction & background
World market trends




1- Introduction & background
Clinical trials around the world




1- Introduction & background
“Pharmerging” markets

                                         Tier 1: China
  Number 3 market with sales
  driven by locally
  manufactured generics &
  imported products

  Consistent double-digit growth   Tier 2: Brazil, Russia, India
  with rising middle-class
  populations, improved
  infrastructure, and IP rights



  Complex, rapidly changing           Tier 3: Fast followers
  markets contributing $1 – 5 bn
  (Venezuela, Poland, Argentina,
  Turkey, Mexico, Vietnam, etc.)
1- Introduction & background
Increases in medical
                  translation volumes

       Globalization           Communications and       Development Pipeline
                                 IT Technology
  Aggressive overseas                                    More products in the
 marketing for sustained       Increase in text-based   pipeline to ensure ROI/
         growth                     information         “blockbuster” products




1- Introduction & background
What it means to specialize


               It’s not enough to know anatomy
              and biology to be a doctor, so why
                would simply being bilingual be
              enough to be a medical translator
                          or interpreter?


1- Introduction & background
The perks of specializing



     Medical translation prioritizes quality
    and expertise over deadlines and costs


                      more profitable market for
                          proficient specialists

1- Introduction & background
… and what will I be translating?
                •    Case report forms/SOAPs
                •    Clinical and instrumental reports
                •    Clinical development/trial data
                •    Drug monographs
                •    Multilingual consulting
                •    Informed Consent Forms
                •    Linguistic validation
                •    Marketing materials
                •    Medical/scientific journal articles
                •    Packaging and labeling
                •    Pharmacovigilance/safety reporting
                •    PRO and QoL instruments
                •    Regulatory documentation
                •    Sales materials
                •    Software and website localization
1- Introduction & background
Stakeholders & clients




1- Introduction & background
Spectrum of points of entry




                          PH Brochures      RA + QC   Drug monographs
    In-country
     validation
     Minimally                                                        Extremely
    specialized                                                      specialized

                                         ICFs
                                                                Protocols




1- Introduction & background
Medical life cycle opportunities


                               Clinical stage




                                                R&D
                Regulatory




               Manufacturing                     Sales &
                                                Marketing

1- Introduction & background
2. Challenges & barriers to entry
Regional divergences


       • Regional differences in the regulatory/
         approval process
       • Locale-specific terminology
       • Variations in healthcare systems
       • Readability index for target population (consent
         forms, patient information leaflets, etc.)




2- Challenges & barriers to entry
Deciphering handwritten notes

                                Extremely common!




2- Challenges & barriers to entry
A known problem!


    From an ISMP – FDA – HHS Campaign




2- Challenges & barriers to entry
… further complicated by
                   translation




2- Challenges & barriers to entry
A practical example

                                    Yikes!




2- Challenges & barriers to entry
Decoding acronyms & symbols

      Symbols and shorthand are common:

                 Be vigilant about creating glossaries/
                 references for your future reference
            * = birth, † = death
              = diastolic blood pressure, v = systolic pressure
              = before, = after
               = start of operation, = end of operation
               = psychologist
            ( ) = possibly significant
              = right upper quadrant
                = plantar response,     = extensor response
            M = murmur
               = fluid ounce
            # = fracture
               = pulse rate, = anesthesia

2- Challenges & barriers to entry
Understanding regulatory
                   requirements

       • EU Medical Device Directive 93/42/EEC requires
         companies to adopt a specific multilingual
         documentation process
       • Use of fully prescribed name
       • Adequate communication of indication
       • Disclosing risk information
            Back-translation is now an essential
            benchmarking tool and quality strategy

2- Challenges & barriers to entry
Medical terminology & jargon

                          Transport pt to OT tid via W/C

     A. Transport patient to occupational therapy
        three times a day via wheelchair
     B. Transport patient for outpatient treatment
         three times a day per
         worker’s compensation
     C. Transport patient to occupational therapy
         three times a week via wheelchair
     D. Transport patient to outpatient treatment
         three times a week via wheelchair

2- Challenges & barriers to entry
The learning gap


       1. Know your limitations
       2. Learn about the regulatory environment for
          your country/language combinations
       3. Research existing products & companies in
          your target language
       4. Invest in your terminology
       5. Never make assumptions! Check, then
          double check!

2- Challenges & barriers to entry
3. Getting it right
Defensive translating


            Part of being a good translator is
           knowing how to diagnose potential
            mistakes before you make them




3- Getting it right
Common misinterpretations




3- Getting it right
Faux amis – False friends

     Cognates and faux amis can be deadly in a
     clinical context
                      Source   Faux amis translation    Correct translation

                        (RU)   Angina (EN)             Tonsillitis
          Auricle (FR)         Auricle (EN)            Atrium
          After (DE)           After (EN)              Anus
          Carbunco (ES)        Carbuncle (EN)          Anthrax
          Aspirazione (IT)     Aspiration (EN)         Suction



3- Getting it right
Terminology shifts

         English has a relatively large vocabulary, creating
         language shifts during translation
                      Source      Translation            Comment


          Aches and pains      Rigidez (ES)     2 words do not exist in
                                                Spanish for “aches”
                                                and “pains”
          Cytomegalovirus                       No abbreviation available in
          (CMV)                (--) (EL)        Greek, use full term
          Magnetic Resonance Segulómun (MRI) Interchangeable use of full
          Imaging (MRI)      (IS)            Icelandic term and borrowed
                                             EN term

3- Getting it right
Geographic usage
                                                             Observation:
                                                       Canada tends to use the
                                                      verb recommander, which
                                                      makes it impossible to use
                                                       recommandations as the
                                                          subject of the verb




                Term         France       Belgium       Switzerland         Canada

 Recommandations                 9            2
 Lignes directrices                                            1                   2
 Guides                          1                                                 1

 Source: “Répertoire des lignes directrices de pratique médicale et tables rondes
 consensus francophones, ” http://www.chu-rouen.fr/ssf/recomfr.html, p. 1-6.



3- Getting it right
Know international standards

     • ICH Good Clinical Practice Guidelines
         How trials should be conducted, roles and
         responsibilities of sponsors,
         investigators, and monitors
     • Declaration of Helsinki
         Ethical principles on human experimentation;
         cornerstone document for human
         research ethics


3- Getting it right
Medical usage & abusage


   • Default to literal/equivalence translations may be
     inappropriate and/or deadly
   • Medical writing uses a specific style and jargon
     that can be foreign to linguists
   • Interlinguistic shifts in terminology




3- Getting it right
Translation strategies


        1. Be methodical: Decode acronyms
                source    expanded source   expanded target   target acronym



        2. Never be satisfied: Research the source term,
           then find proof in the target language

        3. Know your audience: Where does your term fall
           on the scientific spectrum?

3- Getting it right
4. A closer look
Back to our example…
                                                      “Physical exam”
                                                Sometimes we see “examen
                                                objectif” => “objective exam”
                                                  is a common false friend

                                                        Vital signs
                                                Learn these by heart in your
                                                language(s) – along with all
                                                  shorthand/abbreviations

                                                           Systems
                                                   Learn the organ systems
                                                        and associated
                                                   systematic examinations


                                 Abbreviations
                        You will see these… all the time:
4- A closer look                    I promise!
Usage

                    Are you for or against vaccines?

   Vaccin antigrippal, vaccin grippal, vaccin contre la grippe (FR)

    Vacuna antigripal, vacuna gripal, vacuna contra la gripe (ES)




                           Flu vaccine (EN)
4- A closer look
Divergent medical terminology
     Condition          Cause of               English               French
                        condition
Natural sleep                          Sleep                  Sommeil
Condition in         Hypnotism (non-   Hypnosis               Hypnose
which the            drug-related                             Synonyms:
patient responds     maneuvers)                               État hypnotique
to suggestion                                                 État hypnoïde
                     Narcoanalysis,    Subnarcosis            Subnarcose
                     Narcosynthesis                           Synonyms:
                     (Low doses of     Hypnosis               Narcose liminaire
                     anesthesia)                              Hypnose* (not rec.)
Artificial sleep,    Drugs             Narcosis               Narcose
Loss of              (somniferous      Pharmacological
consciousness        drugs,            hypnosis
from anesthesia      anesthesia)       Sleep* (not rec.)
(deep sleep)                           Hypnosis* (not rec.)   Hypnose* (not rec.)
4- A closer look
Term mapping




4- A closer look
Find your niche!




4- A closer look
5. Resources & standards
Essential print references


                               Maxwell Quick Medical Reference
                               Quick pocket reference: ECGs, lab values,
                               formulas and equations, orders, and admission
                               and progress notes


                               The Massachusetts General Hospital
                               Handbook of Internal Medicine
                               A loose-leaf reference on common problems in
                               internal medicine, tables, diagrams,
                               and abbreviations


                               Medical Abbreviations
                               Alphabetic list of abbreviations and acronyms
                               with an index of expanded terms for
                               reverse research



5- Resources & standards
Medical terminology

                           Lab Tests Online
                           Clinical lab test resource
                           www.labtestsonline.org

                           MediLexicon
                           Medical abbreviations and dictionary (English with some
                           French, German, and Spanish translations)
                           www.medilexicon.com

                           Medline Plus Dictionary
                           National Library of Medicine Dictionary
                           www.nlm.nih.gov/medlineplus/mplusdictionary.html

                           Stanford Lay Language Dictionary
                           Glossary of medical terms and corresponding lay terms
                           and definitions
                           www.humansubjects.stanford.edu/new/docs/glossary_definit
                           ions/lay_language.pdf




5- Resources & standards
Approved terminology


EMA – QRD                        IHTSDO – SNOMED               MedDRA

Multilingual QRD templates for   Comprehensive collection of   Clinically validated international
product information              multilingual clinical         medical terminology and
and packaging                    healthcare terminology        AE dictionary

www.ema.europa.eu                www.ihtsdo.org/snomed-ct      www.meddramsso.com




5- Resources & standards
Registries and term banks


       EU Clinical Trials Register                   Medline Plus Dictionary
       EU clinical trials registry                   National Library of Medicine Dictionary
       www.clinicaltrialsregister.eu                 www.nlm.nih.gov/medlineplus/mplusdiction
                                                     ary.html
       WHO International Clinical Trials
       Registry Platform (ICTRP)                     RxList
       Online, multilingual international clinical   Online drug index, including side effects,
       trials registry                               interactions, etc.
       www.who.it/ictrp/en                           www.rxlist.com

       US Clinical Trials Database                   EMA
       US registry of clinical trials in a           Frequently used non-standard
       harmonized format                             abbreviations
       www.clinicaltrials.gov                        www.emea.europa.eu/htms/human/qrd/doc
                                                     s/listnonstandard.pdf




5- Resources & standards
A reference reference

        Tool Box for the Medical Translator
        by Alain Côté
        An absolute essential for novice or experienced
        translators with one of the most comprehensive
        compilations of resources (French –
        English focus)




                                  www.groupetraduction.ca/do
                                  cuments/ToolBox.pdf




5- Resources & standards
Questions?

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So You're Not a Doctor: Taking the Plunge into Medical Translation without an MD

  • 1. Please take the quiz while you wait. So You’re Not a Doctor: Taking the Plunge into Medial Translation without an MD
  • 2. Quiz review: Question 1 In “Administer 300 IU/kg of body weight,” “IU” means: A. Iodine Unit B. 5-Iodouracil C. International Unit D. Intrauterine Quiz
  • 3. Quiz review: Question 2 Which of these does not belong? A. Anjina (TR) B. (RU) C. Angina (EN) D. Angine (FR) Quiz
  • 4. Quiz review: Question 3 The largest therapeutic category for drug development is: A. Central Nervous System B. Infections (HIV, Hepatitis, etc.) C. Autoimmune & Inflammatory Diseases D. Cancer Quiz
  • 5. Quiz review: Question 4 Which of the following is an invasive procedure? A. Stress Echocardiography B. Transesophageal Echocardiogram C. Plain Abdominal X-ray D. Transthoracic Echocardiogram Quiz
  • 6. Quiz review: Question 5 Which of the following is not a national regulatory body? A. FDA B. AFSSAPS C. AQuMed D. Health Canada Quiz
  • 7. Presentation overview 1 Introduction & background 2 Challenges & barriers to entry 3 Getting it right 4 A closer look 5 Resources & standards
  • 8. 1. Introduction & background
  • 9. Industry overview: Fast facts Growth industry 2011 pharma sales > $880 bn Regulatory opportunities It takes the FDA an average of 16 months to approve a new product Expanding geographic/linguistic requirements 25-27% growth in top 17 “pharmerging” countries Sustained growth/aggressive vertical Average cost to bring to market = $500 mn; Average product life cycle = 10 years 1- Introduction & background
  • 10. World market trends 1- Introduction & background
  • 11. Clinical trials around the world 1- Introduction & background
  • 12. “Pharmerging” markets Tier 1: China Number 3 market with sales driven by locally manufactured generics & imported products Consistent double-digit growth Tier 2: Brazil, Russia, India with rising middle-class populations, improved infrastructure, and IP rights Complex, rapidly changing Tier 3: Fast followers markets contributing $1 – 5 bn (Venezuela, Poland, Argentina, Turkey, Mexico, Vietnam, etc.) 1- Introduction & background
  • 13. Increases in medical translation volumes Globalization Communications and Development Pipeline IT Technology Aggressive overseas More products in the marketing for sustained Increase in text-based pipeline to ensure ROI/ growth information “blockbuster” products 1- Introduction & background
  • 14. What it means to specialize It’s not enough to know anatomy and biology to be a doctor, so why would simply being bilingual be enough to be a medical translator or interpreter? 1- Introduction & background
  • 15. The perks of specializing Medical translation prioritizes quality and expertise over deadlines and costs more profitable market for proficient specialists 1- Introduction & background
  • 16. … and what will I be translating? • Case report forms/SOAPs • Clinical and instrumental reports • Clinical development/trial data • Drug monographs • Multilingual consulting • Informed Consent Forms • Linguistic validation • Marketing materials • Medical/scientific journal articles • Packaging and labeling • Pharmacovigilance/safety reporting • PRO and QoL instruments • Regulatory documentation • Sales materials • Software and website localization 1- Introduction & background
  • 17. Stakeholders & clients 1- Introduction & background
  • 18. Spectrum of points of entry PH Brochures RA + QC Drug monographs In-country validation Minimally Extremely specialized specialized ICFs Protocols 1- Introduction & background
  • 19. Medical life cycle opportunities Clinical stage R&D Regulatory Manufacturing Sales & Marketing 1- Introduction & background
  • 20. 2. Challenges & barriers to entry
  • 21. Regional divergences • Regional differences in the regulatory/ approval process • Locale-specific terminology • Variations in healthcare systems • Readability index for target population (consent forms, patient information leaflets, etc.) 2- Challenges & barriers to entry
  • 22. Deciphering handwritten notes Extremely common! 2- Challenges & barriers to entry
  • 23. A known problem! From an ISMP – FDA – HHS Campaign 2- Challenges & barriers to entry
  • 24. … further complicated by translation 2- Challenges & barriers to entry
  • 25. A practical example Yikes! 2- Challenges & barriers to entry
  • 26. Decoding acronyms & symbols Symbols and shorthand are common: Be vigilant about creating glossaries/ references for your future reference * = birth, † = death = diastolic blood pressure, v = systolic pressure = before, = after = start of operation, = end of operation = psychologist ( ) = possibly significant = right upper quadrant = plantar response, = extensor response M = murmur = fluid ounce # = fracture = pulse rate, = anesthesia 2- Challenges & barriers to entry
  • 27. Understanding regulatory requirements • EU Medical Device Directive 93/42/EEC requires companies to adopt a specific multilingual documentation process • Use of fully prescribed name • Adequate communication of indication • Disclosing risk information Back-translation is now an essential benchmarking tool and quality strategy 2- Challenges & barriers to entry
  • 28. Medical terminology & jargon Transport pt to OT tid via W/C A. Transport patient to occupational therapy three times a day via wheelchair B. Transport patient for outpatient treatment three times a day per worker’s compensation C. Transport patient to occupational therapy three times a week via wheelchair D. Transport patient to outpatient treatment three times a week via wheelchair 2- Challenges & barriers to entry
  • 29. The learning gap 1. Know your limitations 2. Learn about the regulatory environment for your country/language combinations 3. Research existing products & companies in your target language 4. Invest in your terminology 5. Never make assumptions! Check, then double check! 2- Challenges & barriers to entry
  • 30. 3. Getting it right
  • 31. Defensive translating Part of being a good translator is knowing how to diagnose potential mistakes before you make them 3- Getting it right
  • 33. Faux amis – False friends Cognates and faux amis can be deadly in a clinical context Source Faux amis translation Correct translation (RU) Angina (EN) Tonsillitis Auricle (FR) Auricle (EN) Atrium After (DE) After (EN) Anus Carbunco (ES) Carbuncle (EN) Anthrax Aspirazione (IT) Aspiration (EN) Suction 3- Getting it right
  • 34. Terminology shifts English has a relatively large vocabulary, creating language shifts during translation Source Translation Comment Aches and pains Rigidez (ES) 2 words do not exist in Spanish for “aches” and “pains” Cytomegalovirus No abbreviation available in (CMV) (--) (EL) Greek, use full term Magnetic Resonance Segulómun (MRI) Interchangeable use of full Imaging (MRI) (IS) Icelandic term and borrowed EN term 3- Getting it right
  • 35. Geographic usage Observation: Canada tends to use the verb recommander, which makes it impossible to use recommandations as the subject of the verb Term France Belgium Switzerland Canada Recommandations 9 2 Lignes directrices 1 2 Guides 1 1 Source: “Répertoire des lignes directrices de pratique médicale et tables rondes consensus francophones, ” http://www.chu-rouen.fr/ssf/recomfr.html, p. 1-6. 3- Getting it right
  • 36. Know international standards • ICH Good Clinical Practice Guidelines How trials should be conducted, roles and responsibilities of sponsors, investigators, and monitors • Declaration of Helsinki Ethical principles on human experimentation; cornerstone document for human research ethics 3- Getting it right
  • 37. Medical usage & abusage • Default to literal/equivalence translations may be inappropriate and/or deadly • Medical writing uses a specific style and jargon that can be foreign to linguists • Interlinguistic shifts in terminology 3- Getting it right
  • 38. Translation strategies 1. Be methodical: Decode acronyms source expanded source expanded target target acronym 2. Never be satisfied: Research the source term, then find proof in the target language 3. Know your audience: Where does your term fall on the scientific spectrum? 3- Getting it right
  • 39. 4. A closer look
  • 40. Back to our example… “Physical exam” Sometimes we see “examen objectif” => “objective exam” is a common false friend Vital signs Learn these by heart in your language(s) – along with all shorthand/abbreviations Systems Learn the organ systems and associated systematic examinations Abbreviations You will see these… all the time: 4- A closer look I promise!
  • 41. Usage Are you for or against vaccines? Vaccin antigrippal, vaccin grippal, vaccin contre la grippe (FR) Vacuna antigripal, vacuna gripal, vacuna contra la gripe (ES) Flu vaccine (EN) 4- A closer look
  • 42. Divergent medical terminology Condition Cause of English French condition Natural sleep Sleep Sommeil Condition in Hypnotism (non- Hypnosis Hypnose which the drug-related Synonyms: patient responds maneuvers) État hypnotique to suggestion État hypnoïde Narcoanalysis, Subnarcosis Subnarcose Narcosynthesis Synonyms: (Low doses of Hypnosis Narcose liminaire anesthesia) Hypnose* (not rec.) Artificial sleep, Drugs Narcosis Narcose Loss of (somniferous Pharmacological consciousness drugs, hypnosis from anesthesia anesthesia) Sleep* (not rec.) (deep sleep) Hypnosis* (not rec.) Hypnose* (not rec.) 4- A closer look
  • 43. Term mapping 4- A closer look
  • 44. Find your niche! 4- A closer look
  • 45. 5. Resources & standards
  • 46. Essential print references Maxwell Quick Medical Reference Quick pocket reference: ECGs, lab values, formulas and equations, orders, and admission and progress notes The Massachusetts General Hospital Handbook of Internal Medicine A loose-leaf reference on common problems in internal medicine, tables, diagrams, and abbreviations Medical Abbreviations Alphabetic list of abbreviations and acronyms with an index of expanded terms for reverse research 5- Resources & standards
  • 47. Medical terminology Lab Tests Online Clinical lab test resource www.labtestsonline.org MediLexicon Medical abbreviations and dictionary (English with some French, German, and Spanish translations) www.medilexicon.com Medline Plus Dictionary National Library of Medicine Dictionary www.nlm.nih.gov/medlineplus/mplusdictionary.html Stanford Lay Language Dictionary Glossary of medical terms and corresponding lay terms and definitions www.humansubjects.stanford.edu/new/docs/glossary_definit ions/lay_language.pdf 5- Resources & standards
  • 48. Approved terminology EMA – QRD IHTSDO – SNOMED MedDRA Multilingual QRD templates for Comprehensive collection of Clinically validated international product information multilingual clinical medical terminology and and packaging healthcare terminology AE dictionary www.ema.europa.eu www.ihtsdo.org/snomed-ct www.meddramsso.com 5- Resources & standards
  • 49. Registries and term banks EU Clinical Trials Register Medline Plus Dictionary EU clinical trials registry National Library of Medicine Dictionary www.clinicaltrialsregister.eu www.nlm.nih.gov/medlineplus/mplusdiction ary.html WHO International Clinical Trials Registry Platform (ICTRP) RxList Online, multilingual international clinical Online drug index, including side effects, trials registry interactions, etc. www.who.it/ictrp/en www.rxlist.com US Clinical Trials Database EMA US registry of clinical trials in a Frequently used non-standard harmonized format abbreviations www.clinicaltrials.gov www.emea.europa.eu/htms/human/qrd/doc s/listnonstandard.pdf 5- Resources & standards
  • 50. A reference reference Tool Box for the Medical Translator by Alain Côté An absolute essential for novice or experienced translators with one of the most comprehensive compilations of resources (French – English focus) www.groupetraduction.ca/do cuments/ToolBox.pdf 5- Resources & standards