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Erin M. Lyons
What’s in Your Kit?
The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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Webinar Quiz: Question 1
What is the “gold standard” for collecting evidence about the performance of a medical device?
A. Case seriesB. Randomized controlled trial C. Observational studyD. Integrative study
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Webinar Quiz: Question 2What is a “Notified Body” in European medical device regulation?
A. An entity of a national government in the EU entitled to grant approval
B. A private organization accredited by the government entitled to grant approval
C. The manufacturer labeling the product with the CE marking
D. A subcommittee of the Directorates-General of Health and Consumers
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Webinar Quiz: Question 3Physicien (FR) means:
A. Physical therapistB. PhysicianC. PhysiologistD. Physicist
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Webinar Quiz: Question 4Which of these does not belong?
A. Desinfectado (ES)B. Disinfected (EN)C. Désinfecté (FR)D. Desinfektiert (DE)
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Webinar Quiz: Question 5Documentation necessary to enroll a patient in a trial:
A. ProtocolB. Case report form C. Informed consent form D. Investigator’s brochure
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Webinar snapshot
• To summarize the clinical trial pipeline• To address terminological challenges• To contextualize electronic documentation
and technological developments for translators
• To identify dedicated linguistic resources
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Clinical Trials: The Basics
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What is a clinical trial?
• Biomedical or health-related research studies that follow a pre-defined protocol
• One of the final stages in the long process of drug research and discovery
• Required for marketing authorizationfrom regulatory authorities
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Types of clinical trials
• Treatment trials• Prevention trials• Diagnostic trials• Screening trials• Quality of life/Supportive care trials
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Clinical trial phases
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Global: Not a should but a must
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
• To strengthen intellectual property• To decrease time-to-market (millions in
potential revenue)• To capitalize on seasonal reversal in
Southern Hemisphere (allergies, flu, etc.)
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So many trials… so few patients
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Poll 1: Foreign participation
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Poll 1: Foreign participation
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
What percentage of subjects participating in clinical trials supporting marketing applications for drugs were enrolled at foreign sites?
87% (foreign subjects in clinical trials on biologics)21% 57%% 10%
Source: “Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials,” Dept. of Health and Human Services Office of Inspector General, June 2010.http://oig.hhs.gov/oei/reports/oei-01-08-00510.pdf
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Growth in overseas trials
• Over 40% of US-regulated trials are conducted oversees
• In the next two to three years, up to 65% of FDA-regulated trials will be conducted abroad
• “Pharmerging” markets: Brazil, China, Russia, India
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Clinical trials around the world
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International trials in the news
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International standards
• 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
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
Available in multiple languages (including
glossaries)
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Terminology Challenges
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Medical usage and 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
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Poll 2: Localization
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Localization: Regulatory
• Institutional Review Board (IRB)Group of scientists, doctors, clergy, and consumers at each participating health facility who evaluate and approve the trial design and protocol.
Ethics Committee (EC)Comité de protection de personnes (CPP)Research Ethics Board (REB)
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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, etc.)
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Geographic usage
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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
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Terminology shifts• English has a relatively large vocabulary,
creating language shifts during translation
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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
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Faux amis – False friends• Cognates and faux amis can be deadly in
a clinical context
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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
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Cases, Patients, Subjects, Controls• Patient
A person receiving medical care• Case
An instance of a disorder or disease• Subject
A human/animal with a particular characteristic• Control (subject)
A human/animal that does not have that particular characteristic
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Efficacy vs. Effectiveness
• EfficacyDemonstrates a benefit under design or research conditions (research setting)
• EffectivenessDemonstrates a benefit under conditions of actual use (day-to-day clinical practice)
Example: Pulse oximeters have demonstrated their efficacy, but clinical studies are being performed to demonstrate their effectiveness
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Prevalence vs. Incidence
• PrevalenceProportion of new events in a population or group of patients
• IncidenceThe rate of development of new events in a population or group of patients per unit of time
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Divergent medical terminology
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Condition Cause of condition
English French
Natural sleep Sleep Sommeil
Condition 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.)
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Usage: 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)
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Getting it Right: Term Mapping
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Remember:
• Know your limitations• Expand your toolbox• Different jobs require different approaches• Don’t make assumptions: check and
double check
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Electronic Documentation and Technology
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Wave of the future
• It is only a matter of time before all source data is captured in electronic format
Eliminates unnecessary duplication of dataReduces the opportunity for transcription errorsPromotes real-time entry of source data during visitsEnsures the accuracy and completeness of data
• Until then… we have the eCRF!
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What is an eCRF?
• A vehicle to assemble data from electronic- and paper-based systems
• Captures and organizes diverse data to satisfy the study protocol
• Enables the data to be systematically reviewed and analyzed by investigators and other authorized parties
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Poll 3: eCRFs
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Poll 3: eCRFs
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
True or False: eCRFs will replace ALLsource documentation (progress notes, lab results, X-rays, etc.)?
TrueFalse
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Assembling data using an eCRF
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What does this mean for translators?• Translation and transfer of medical data to
a harmonized format• Translation of eCRF and QA prompts• Translation of site-specific reporting forms
for automated import into eCRF• Translation of local proprietary input
systems (not global-ready)
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Translators and QA
• Back-translation is an essential benchmarking tool
• Development of glossaries and controlled input language for languages/locales
• Stakeholder in regulatory review/audits• “Clean” data review
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Back-translation & in-country review• Informed consent forms, patient-reported
outcomes Back-translation confirms that content and readability are unaffected
• Marketing materials and labelingIn-country review guarantees appropriateness for specific markets
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Controlled language and CAT
• Upstream internationalization and localization of embedded systems
• Mapping to classifications and standard glossaries (Systematized Nomenclature of Medicine – Clinical Terms, SNOMED CT)
• Downstream translation and retooling for specific markets
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A virtual collaborative environment
• Translators link data managers and local clinicians via central database regardless of language or location
• Multilingual IVRS integration• Real-time roll-out of protocol changes• Translators on call for out-of-box
adverse events
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Content repurposing
• Translators adapt and repurpose content (media syndication, Web publishing, etc.)
• Trans-adaptation and push-button publishing
• Consolidation and review in regulated fields
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A double-edged sword?
• Accelerated timelines and more commodity-driven process
• TMs/glossaries are not “intelligent” tools• Technological learning curve
for translators• Costly add-on tools?
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Resources
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General Clinical Trial Resources• EU Clinical Trials Register
Primary registry of WHO’s International Clinical Trials Registry Platformwww.clinicaltrialsregister.eu
• European Union Drug Regulating Authorities Pharmacovigilance (EudraVigilance)EMA scientific guidelineswww.Eudravigilance.emea.europe.eu
• US Clinical Trials DatabaseUS registry of clinical trials in a harmonized formatwww.clinicaltrials.gov
• WHO International Clinical Trials Registry Platform (ICTRP)Online, multilingual international clinical trials registrywww.who.it/ictrp/en
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Clinical Trial Terminology• Johns Hopkins Medicine IRB Guidelines
Glossaries, templates, and guidelines on the clinical trial processwww.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/
• The Medical Dictionary for Regulatory Activities (MedDRA) Reference for describing adverse eventswww.meddramsso.com
• Stanford Clinical Trials DictionaryGlossary of terms specific to clinical researchhumansubjects.stanford.edu/new/docs/glossary_definitions/definitions.pdf
• Stanford Lay Language DictionaryGlossary of medical terms and corresponding lay terms and definitionshumansubjects.stanford.edu/new/docs/glossary_definitions/lay_language.pdf
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Informed Consent• Coded ICF Lexicon
Term or phrase with alternatives to medical terminologywww.calgb.org/Public/meetings/presentations/2009/summer_group/cra_cont_ed/04c_lexicon_062009.pdf
• Stanford ICF templates and subject bill of rightsWith templates in English, Chinese, Farsi, Japanese, Korean, Russian, Spanish, and Vietnamesehumansubjects.stanford.edu/new/resources/consent/short_form_consent_process.html
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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Medical Terminology• MediLexicon
Medical 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
• RxListOnline drug index, including side effects, interactions, etc.www.rxlist.com
• EMAFrequently used non-standard abbreviationshttp://www.emea.europa.eu/htms/human/qrd/docs/listnonstandard.pdf
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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Essential Print Resources
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
• Davis, Neil M. Medical Abbreviations: 15,000 Conveniences at the Expense of Communications and Safety, 10th ed. Huntington Valley, PA: Davis Associates, 2001.
• Donaldson, Ross. Tarascon Medical Translation Pocketbook, 1 Mul. ed. Boston: Jones and Bartlett: 2009.
• Maxwell, Robert. Maxwell Quick Medical Reference, 5th ed. Maxwell Pub. Co., 2006.
• Sabatine, Marc S. Pocket Medicine: The Massachusetts General Hospital Handbook of Internal Medicine , 3rd ed. Philadelphia: Wolters Kluwer, 2008.
• Stanaszek, Mary J. The Inverted Medical Dictionary. Lancaster, PA: Technomic, 1991.
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Tool Box For the Medical Translator
• One of the most comprehensive lists of resources for novice or experienced medical translatorshttp://www.groupetraduction.ca/documents/ToolBox.pdf
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation
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Questions?
What’s in Your Kit? The Medical Translator’s Guide to Navigating Clinical Trials and Investigational Documentation