Thursday, October 26, 3:30pm-4:30pm
In the second JDL session of the conference, we had an opportunity to hear and learn from Dr. Matthew Schlect about Japanese to English translation of clinical trial documents. Dr. Schlect was a researcher in chemistry and life sciences for 20 years before he started his freelance work and has been a freelance translator, editor and writer for 15 years. He is currently a member of the leadership council for ATA’s Science and Technology Division.
As a part of his introduction, Japanese medical language was discussed:
- Japanese medical terms are often compounds of familiar elements (e.g. 糖尿病), while many English medical terms came from Latin and Greek (e.g. diabetes).
- Japanese has many medical terms borrowed from English and German (e.g. カテーテル (catheter) and ゾンデ (Sonde (German), probe (English))).
- Japan has a long tradition of Oriental Medicine (漢方), and Western science and medicine were introduced to Japan from Germany through Dutch merchants in the Meiji Era (1868-1912)
Then the following were presented:
- Clinical trials (what, who and why)
- Types of clinical trials (Phase I (第Ｉ相試験), Phase II (第Ⅱ相試験), etc.)
- Clinical design (Some key terms were discussed.) (blinding (盲検化), endpoint (評価項目), etc.)
- Those who are involved in clinical trials (principal investigator (治験責任医師), sponsor (治験依頼者), etc.)
- Clinical trial facilities (study center (治験実施医療機関), testing facilities (試験実施施設), etc.)
- Clinical trial documents and formats with examples.
- Clinical trial protocol (治験実施計画書)
- Investigator’s Brochure (IB) (治験薬概要書)
- Clinical trial agreement/contract (治験実施契約書)
- Clinical trial report (治験報告書)
- Standard Operating Procedures (SOPs) (標準業務手順書)
- Informed Consent Forms (ICF) (同意説明文書)
- Case Report Form (CRF) (症例報告書)
- Institutional Review Board (IRB) Report (治験審査委員会報告書)
- Medical Journal Articles (医学雑誌の記事)
Following the discussion above, terminology – standardized clinical nomenclature (MedDRA) and Common Terminology Criteria for Adverse Events (CTCAE), and drug/disease/procedure names were discussed followed by the process of translation of clinical trials. Dr. Schlect pointed out that there are three steps in the translation process: research, translation, and validation:
Skim through title, abstract, key words, unfamiliar terms.
Research unfamiliar topics in the source & target language
Clinical trial databases
WHO International Clinical Trials Registry (http://www.who.int/ictrp/en/)
US National Library of Medicine Clinical Trials Registry (https://www.clinicaltrials.gov/ct2/home)
EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/)
- Validation: Validate that key translation terms/phrases are found “in the wild” in texts written by native authors.
At the conclusion, Dr. Schlect told us: To succeed at clinical translation,
- Being a doctor or nurse is not a requirement.
- Do need careful research, translation, and validation
- Experience with clinical content will facilitate professional clinical document translations
- Controlled language (MeDRA, CTCAE) seems tedious, but standardization is necessary
- Use the extensive resource available
He also presented useful English medical resources, Japanese to English resources, and clinical terminology resources. Below are some of the resources:
- NIH PubMed (https://www.ncbi.nlm.nih.gov/pubmed)
- Sangyo 怒涛の辞書（翻訳例辞書）(https://www.sangyo-honyaku.jp/dictionaries)
- ライフサイエンス辞書オンラインサービス (https://lsd-project.jp/cgi-bin/lsdproj/ejlookup04.pl)
- CDISC Clinical Research Glossary (EN/JA) (http://www.tri-kobe.org/cdisc/glossary/glossary.php