So You’re Not a Doctor:Taking the Plunge into Medial

Translation without an MD

Please take the quiz while you wait.

Quiz review: Question 1

In “Administer 300 IU/kg of body weight,” “IU” means:

A. Iodine UnitB. 5-IodouracilC. 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 SystemB. Infections (HIV, Hepatitis, etc.)C. Autoimmune & Inflammatory DiseasesD. Cancer

Quiz

Quiz review: Question 4

Which of the following is an invasive procedure?A. Stress EchocardiographyB. Transesophageal EchocardiogramC. Plain Abdominal X-rayD. Transthoracic Echocardiogram

Quiz

Quiz review: Question 5

Which of the following is not a national regulatory body?

A. FDAB. AFSSAPSC. AQuMedD. Health Canada

Quiz

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1 Introduction & background

Challenges & barriers to entry

Getting it right

A closer look

5 Resources & standards

Presentation overview

1. Introduction & background

Industry overview: Fast facts

1- Introduction & background

2011 pharma sales > $880 bn

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

It takes the FDA an average of 16 months to approve a new product

Growth industry

Regulatory opportunities

Expanding geographic/linguistic requirements

Average cost to bring to market = $500 mn; Average product life cycle = 10 years

Sustained growth/aggressive vertical

World market trends

1- Introduction & background

Clinical trials around the world

1- Introduction & background

“Pharmerging” markets

1- Introduction & background

Tier 1: China

Tier 2: Brazil, Russia, India

Tier 3: Fast followers

Number 3 market with sales driven by locally manufactured generics & imported products

Consistent double-digit growth with rising middle-class populations, improved infrastructure, and IP rights

Complex, rapidly changing markets contributing $1 – 5 bn (Venezuela, Poland, Argentina, Turkey, Mexico, Vietnam, etc.)

Increases in medical translation volumes

1- Introduction & background

Globalization

Aggressive overseas marketing for sustained

growth

Communications and IT Technology

Increase in text-based information

Development Pipeline

More products in the pipeline to ensure ROI/ “blockbuster” products

What it means to specialize

1- Introduction & background

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?

The perks of specializing

1- Introduction & background

Medical translation prioritizes quality and expertise over deadlines and costs

more profitable market for proficient specialists

… and what will I be translating?

1- Introduction & background

• 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

Stakeholders & clients

1- Introduction & background

Spectrum of points of entry

1- Introduction & background

Extremely specialized

Minimally specialized

ICFs

Drug monographs

Protocols

PH BrochuresIn-country validation

RA + QC

Medical life cycle opportunities

1- Introduction & background

Regulatory

Clinical stage

R & D

Manufacturing Sales & Marketing

2. Challenges & barriers to entry

Regional divergences

2- Challenges & barriers to entry

• 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.)

Deciphering handwritten notes

2- Challenges & barriers to entry

Extremely common!

A known problem!

2- Challenges & barriers to entry

From an ISMP – FDA – HHS Campaign

… further complicated by translation

2- Challenges & barriers to entry

A practical example

2- Challenges & barriers to entry

Yikes!

Decoding acronyms & symbols

2- Challenges & barriers to entry

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

Understanding regulatory requirements

2- Challenges & barriers to entry

• 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

Medical terminology & jargon

2- Challenges & barriers to entry

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 treatmentthree times a day per worker’s compensation

C. Transport patient to occupational therapythree times a week via wheelchair

D. Transport patient to outpatient treatmentthree times a week via wheelchair

The learning gap

2- Challenges & barriers to entry

1. Know your limitations2. Learn about the regulatory environment for

your country/language combinations3. Research existing products & companies in

your target language4. Invest in your terminology5. Never make assumptions! Check, then

double check!

3. Getting it right

Defensive translating

3- Getting it right

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

Common misinterpretations

3- Getting it right

Faux amis – False friends

3- Getting it right

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

Terminology shifts

3- Getting it right

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 (CMV) (--) (EL)

No abbreviation available in Greek, use full term

Magnetic ResonanceImaging (MRI)

Segulómun (MRI) (IS)

Interchangeable use of full Icelandic term and borrowed EN term

Geographic usage

3- Getting it right

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.

Observation: Canada tends to use the

verb recommander, which makes it impossible to use recommandations as the

subject of the verb

Know international standards

3- Getting it right

• ICH Good Clinical Practice GuidelinesHow trials should be conducted, roles and responsibilities of sponsors, investigators, and monitors

• Declaration of HelsinkiEthical principles on human experimentation; cornerstone document for human research ethics

Medical usage & abusage

3- Getting it right

• 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

Translation strategies

3- Getting it right

1. Be methodical: Decode acronymssource 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?

4. A closer look

Back to our example…

4- A closer look

“Physical exam”Sometimes we see “examen objectif” => “objective exam”

is a common false friend

Vital signsLearn these by heart in your language(s) – along with all

shorthand/abbreviations

SystemsLearn the organ systems

and associated systematic examinations

AbbreviationsYou will see these… all the time:

I promise!

Usage

4- A closer look

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)

Condition Cause of condition

English French

Natural sleep Sleep SommeilCondition in which the patient responds to suggestion

Hypnotism (non-drug-related maneuvers)

Hypnosis HypnoseSynonyms:État hypnotiqueÉtat hypnoïde

Narcoanalysis, Narcosynthesis (Low doses of anesthesia)

Subnarcosis

Hypnosis

SubnarcoseSynonyms:Narcose liminaireHypnose* (not rec.)

Artificial sleep, Loss of consciousnessfrom anesthesia (deep sleep)

Drugs (somniferous drugs, anesthesia)

NarcosisPharmacologicalhypnosisSleep* (not rec.)Hypnosis* (not rec.)

Narcose

Hypnose* (not rec.)

Divergent medical terminology

4- A closer look

Term mapping

4- A closer look

Find your niche!

4- A closer look

5. Resources & standards

Essential print references

5- Resources & standards

Maxwell Quick Medical ReferenceQuick 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

Medical terminology

5- Resources & standards

Lab Tests OnlineClinical lab test resourcewww.labtestsonline.org

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

Medline Plus DictionaryNational Library of Medicine Dictionarywww.nlm.nih.gov/medlineplus/mplusdictionary.html

Stanford Lay Language DictionaryGlossary of medical terms and corresponding lay terms and definitionswww.humansubjects.stanford.edu/new/docs/glossary_definitions/lay_language.pdf

EMA – QRD

Multilingual QRD templates for product information and packaging

www.ema.europa.eu

Approved terminology

5- Resources & standards

IHTSDO – SNOMED

Comprehensive collection of multilingual clinical healthcare terminology

www.ihtsdo.org/snomed-ct

MedDRA

Clinically validated international medical terminology and AE dictionary

www.meddramsso.com

Registries and term banks

5- Resources & standards

EU Clinical Trials RegisterEU clinical trials registrywww.clinicaltrialsregister.eu

WHO International Clinical Trials Registry Platform (ICTRP)Online, multilingual international clinical trials registrywww.who.it/ictrp/en

US Clinical Trials DatabaseUS registry of clinical trials in a harmonized formatwww.clinicaltrials.gov

Medline Plus DictionaryNational Library of Medicine Dictionarywww.nlm.nih.gov/medlineplus/mplusdictionary.html

RxListOnline drug index, including side effects, interactions, etc.www.rxlist.com

EMAFrequently used non-standard abbreviationswww.emea.europa.eu/htms/human/qrd/docs/listnonstandard.pdf

A reference reference

5- Resources & standards

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

www.groupetraduction.ca/documents/ToolBox.pdf

Questions?