Transcript Title

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
GLOBAL BIOMETRICS
Biostatistics
Clinical Data Management
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Topics
I. High level introduction about the project
II. Table translation process and tool features
III. Recommended working process
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High level introduction about the project
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Example
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Example
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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
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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
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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
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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.
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Introduction of the Tool Design and the Features
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Tool Design
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
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Biostatistics
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
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Biostatistics
Clinical Data Management
Epidemiology & Patient Reported Outcomes
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Operations
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Tool Design (Continued)
Step 1
Step 2
Source
Import
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
Step 3
Data
processing
•Combine the
wraped terms into
one line
Step 4
Step 5
Step 6
Translate
Review
Report
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
NEOPLASMS BENIGN, MALIGNANT AND
UNSPECIFIED (INCL CYSTS AND
POLYPS)
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
AE term – MedDRA
Medication term & others – translation dictionary
(Ongoing)
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
 one-to-one mapping
 No duplicated terms
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
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Biostatistics
Clinical Data Management
Epidemiology & Patient Reported Outcomes
Statistical Programming and Analysis
Operations
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
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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
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Table examples
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Table examples
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Table examples
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Table examples
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
TXT FILE.txt
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Current limitation and further investigation
Limitation
• We can’t translate medication
terms in an efficient way for
now
a) We are using in-house
dictionary which is only
in English to do
medical coding for
medication
b) Roche didn’t purchase
WHODD (WHO Drug
Dictionary) which has
Chinese translation for
medication terms
Investigation
• Two options to translate
medication terms
a) Create our own
Chinese translation
for all medications
used in our studies
b) Purchase any
commercial
dictionary. It needs to
be further
investigated
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Biostatistics
Clinical Data Management
Epidemiology & Patient Reported Outcomes
Statistical Programming and Analysis
Operations
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Recommended working process
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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
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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
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Thank you!
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