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Analysis Table Translation Tool - From English to Chinese

Analysis Table Translation Tool - From English to Chinese. Jessie Zhao, intern Mina Chen, intern Shengying Cheng, Project Manager of the Internship Program Yanyun Shen, Site Head of APAC Statistical Programming & Analysis. Topics. High level introduction about the project

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Analysis Table Translation Tool - From English to Chinese

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  1. Analysis Table Translation Tool-From English to Chinese Jessie Zhao, intern Mina Chen, intern Shengying Cheng, Project Manager of the Internship Program Yanyun Shen, Site Head of APAC Statistical Programming & Analysis

  2. Topics • High level introduction about the project • Table translation process and tool features • Recommended working process

  3. High level introduction about the project

  4. Example

  5. Example

  6. Why is it necessary to develop this tool? • According to sFDA (State Food and Drug Administration) requirement, all CSR including in-text tables should be in Chinese • Previously the translation was performed manually by vendor companies which require statisticians and clinical science’s review which is both costly and extra time consuming • There was risk to edit the statistical result incidentally • Due to system restrictions from the company, Chinese analysis tables can not be generated directly from SAS software

  7. What’s the benefit of this tool? • Produce high quality tables in Chinese • To translate AE terms, we utilize the MedDRA and its Chinese translation published by MSSO (Maintenance and Support Services Organization) • Quality check is not necessary to be repeated once we have a dictionary to translate some other frequent used terms • Accelerate the submission • Reduce the time for CSR translation • Our colleagues will save time for checking the quality and discussion back and forth • Our colleagues don’t need reformat the translated tables manually because we can generate the Chinese tables with the same format as those tables in English

  8. What’s the benefit of this tool? (cont.) • Efficiency gains • This tool can be reused for any studies in any therapeutic areas • This tool is user friendly. It’s very easy to learn how to use it • It’s applicable to translate tables from English to other languages • It can be used for other language translation by using the same program • We only need update the dictionaries

  9. Challenges • We can’t translate medication terms as the same way as we translate adverse event terms. • We are using in-house dictionary which is only in English to do medical coding for medication. • The company didn’t purchase WHODD (WHO Drug Dictionary) which has Chinese translation for medication terms • There are two ways to solve this issue, either to create our own Chinese translation for all medications used in our studies or purchase any commercial dictionary. It needs to be further investigated.

  10. Introduction of the Tool Design and the Features

  11. Tool Design Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset

  12. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset

  13. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)

  14. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset AE term – MedDRA Medication term & others – translation dictionary (Ongoing)

  15. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset

  16. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset • one-to-one mapping • No duplicated terms

  17. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset

  18. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset

  19. Tool Features • Quality can be guaranteed • No need to add or remove any spaces in translated tables manually • MedDRA is utilized to translate adverse events • Any new terms will be confirmed with Biostat and Scientist prior to translation • Column width can be defined automatically • Long terms can be wrapped automatically • It’s flexible to translate multiple columns in one table synchronously • It’s easy to identify if there is no relative Chinese translation for any terms • Titles, footnotes and column names should be translated separately • Table format is the same as the one in English

  20. Table examples

  21. Table examples

  22. Table examples

  23. Table examples

  24. Tool Design (Continued) Step 6 Report Step 2 Import Step 3 Step 4 Translate Step 5 Review Step 1 Source Data processing • Table in txt file is the source • Add separator “|” in the table • Confirm the translation with Biostatistician and Scientist • Create the table in Chinese (RTF/PDF/TXT) • Combine the wraped terms into one line • Translate English terms into Chinese • Save the table into a dataset TXT FILE.txt

  25. Current limitation and further investigation Limitation Investigation • We can’t translate medication terms in an efficient way for now • We are using in-house dictionary which is only in English to do medical coding for medication • Roche didn’t purchase WHODD (WHO Drug Dictionary) which has Chinese translation for medication terms • Two options to translate medication terms • Create our own Chinese translation for all medications used in our studies • Purchase any commercial dictionary. It needs to be further investigated

  26. Recommended working process

  27. Recommended working process • Suggestion to biostatistician and scientist • Add identifier for tables which need translation in LOPO to ensure most of tables would be translated prior to CSR generation • Continue to add identifiers in LOPO prior to CSR finalization and update with SPA

  28. Summary • This tool can translate tables from English to Chinese (or other languages) in good quality • It has great potential to accelerate the submission • Need further investigation to solve current limitations • It is a great internship program to provide an opportunity for staff development

  29. Thank you!

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