UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058346 |
|---|---|
| Receipt number | R000066519 |
| Scientific Title | Efficacy of a large language model (LLM) data extraction system for simplifying evidence reviews of emerging infectious diseases: A randomized crossover trial |
| Date of disclosure of the study information | 2025/07/02 |
| Last modified on | 2025/07/02 14:50:10 |
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Basic information
Public title
Efficacy of a large language model (LLM) data extraction system for simplifying evidence reviews of emerging infectious diseases: A randomized crossover trial
Acronym
LLM data extraction system crossover RCT for emerging infectious disease evidence review
Scientific Title
Efficacy of a large language model (LLM) data extraction system for simplifying evidence reviews of emerging infectious diseases: A randomized crossover trial
Scientific Title:Acronym
LLM data extraction system crossover RCT for emerging infectious disease evidence review
Region
| Japan |
Condition
Condition
Emerging Infectious Diseases (Evidence Review Efficiency Research)
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the hypothesis that using an LLM system reduces data input time to web forms and improves data extraction efficiency compared to not using the system. To evaluate whether using an LLM system improves time efficiency when extracting data from papers on emerging infectious diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time from authentication of subject ID after accessing the web form and starting input until completion of input
Key secondary outcomes
Accuracy of data extraction (experts check data extracted by participants for errors and calculate the percentage of correct answers)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
LLM System Use (Using structured data extraction system from papers with OpenAI o4-mini latest version to input into Streamlit web form)
Interventions/Control_2
No LLM System Use (Reading paper PDFs directly and manually inputting into Streamlit web form)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Researchers or healthcare professionals with experience in evidence review
2. Researchers or healthcare professionals specializing in infectious diseases
3. Individuals with basic computer skills
4. Individuals who have consented to participate in the research
Key exclusion criteria
1. Individuals with severe visual impairment
2. Individuals participating in an environment with unstable internet connection
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Ishikane |
Organization
National Center for Global Health and Medicine, Japan Institute for Health Security
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
ishikanemasahiro@gmail.com
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ishikane |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
TEL
03-3202-7181
Homepage URL
ishikanemasahiro@gmail.com
Sponsor or person
Institute
Japan Institute for Health Security
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Institute for Health Security
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
Tel
03-3202-7181
ishikanemasahiro@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
https://github.com/SRWS-PSG/emerging_infection_24K13518
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066519
