Biomedical ResearchNCT06962423
AI-driven Automated Biomedical Research
A study testing AI system in people with Biomedical Research and Artificial Intelligence (AI), run by Tsinghua University at 1 site in China.
Trial summary
This study will evaluate the effects of the AI system developed by our team on biomedical research. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biomedical Research, Artificial Intelligence (AI)
- What is being tested?
- AI system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) Age ≥ 18 years old;
- (2) Agree to sign consent form and invest time in this study;
- (3) Able to understand and complete research tasks.
Who cannot join
- (1) Currently participating in other projects that may interfere with this research and unable to ensure participation time;
- (2) Have a history of major diseases or poor physical condition in the past three months that may affect research participation;
- (3) Unwilling or unable to understand and complete the research tasks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tsinghua University
Beijing, Beijing Municipality, 100084
Junxian Hong, +86 18800129260, hongjx17@mails.tsinghua.edu.cn
About this study
Official title: A Study on Artificial Intelligence-based Automated Biomedical Research
This study will evaluate the effects of the AI system developed by our team on biomedical research.
Read the detailed description
It i a randomized-controlled study. Participants will be randomly assigned to the Intervention Group using our AI system and the Control Group. Both groups will perform the same biomedical research tasks and submit reports. At the end of the study, the research performance of the two groups will be evaluated.
- Conditions
- Biomedical Research, Artificial Intelligence (AI)
- Being tested
- AI system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI systemOther
Participants will complete the research task with the AI system developed by out team to perform automated biomedical research.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants will complete the research task without our AI system. |
| Intervention group | Experimental | Participants will complete the research task with AI system developed by our team. Receives: Other: AI system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research quality evaluation scale
Independent senior experts will evaluate the research reports from the Intervention Group and the Control Group using a standardized 100-point Research Quality Evaluation Scale. A higher score indicates better research quality.
Measured: Through study completion, an average of 1 week
Secondary outcomes (4)
Model performance
The diagnostic accuracy, sensitivity, specificity, and area under the receiver-operating characteristic curve (AUC-ROC) will be reported to compare the performance of models generated by the Intervention Group and the Control Group.
Measured: Through study completion, an average of 1 week
Research time cost
The time spent by the Intervention Group and the Control Group to complete tasks will be compared.
Measured: Through study completion, an average of 1 week
User evaluation
User evaluation on the study will be assessed by Likert Scales.
Measured: Through study completion, an average of 1 week
Model resource consumption
GPU usage rate and time and model size will be tracked and compared to evaluate the computational resource consumption of the Intervention Group and Control Group.
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start15 May 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomedical ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tien Yin Wong, Tsinghua University
- Investigators
- Tien Yin Wong, Principal investigator, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962423
- Sponsor's protocol ID
- THU01-20250025
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Artificial Intelligence-based Automated Biomedical Research
- ClinicalTrials.gov ID
- NCT06962423
- Acronym / sponsor ID
- THU01-20250025
- Conditions
- Biomedical Research, Artificial Intelligence (AI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of the AI system developed by our team on biomedical research.
Detailed description
It i a randomized-controlled study. Participants will be randomly assigned to the Intervention Group using our AI system and the Control Group. Both groups will perform the same biomedical research tasks and submit reports. At the end of the study, the research performance of the two groups will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants will complete the research task without our AI system. |
| Intervention group | Experimental | Other: AI systemParticipants will complete the research task with AI system developed by our team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) Age ≥ 18 years old;
- (2) Agree to sign consent form and invest time in this study;
- (3) Able to understand and complete research tasks.
Key exclusion criteria (3 listed)
- (1) Currently participating in other projects that may interfere with this research and unable to ensure participation time;
- (2) Have a history of major diseases or poor physical condition in the past three months that may affect research participation;
- (3) Unwilling or unable to understand and complete the research tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI systemParticipants will complete the research task with the AI system developed by out team to perform automated biomedical research. | Other | Intervention group |
Primary outcome
Research quality evaluation scale
Time frame: Through study completion, an average of 1 week
Independent senior experts will evaluate the research reports from the Intervention Group and the Control Group using a standardized 100-point Research Quality Evaluation Scale. A higher score indicates better research quality.
4 secondary outcomes
Model performance
Time frame: Through study completion, an average of 1 week
Research time cost
Time frame: Through study completion, an average of 1 week
User evaluation
Time frame: Through study completion, an average of 1 week
Model resource consumption
Time frame: Through study completion, an average of 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tien Yin Wong principal investigator
Tsinghua University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI system in people with Biomedical Research and Artificial Intelligence (AI), run by Tsinghua University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junxian Hong (+86 18800129260, hongjx17@mails.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research quality evaluation scale (time frame: Through study completion, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.