ClinicalTrials.gg
RecruitingNCT07808866Updated Sep 9, 2026

Multi-Agent Collaborative ADR Prediction With Human-Machine Decision Comparison

An observational study in Adverse Drug Reactions and Clinical Decision Support, sponsored by Peking University Third Hospital. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.

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Study type
Observational
Model
Other
Time perspective
Other
Enrollment
20,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 53 studies in Drug-Related Side Effects and Adverse Reactions with a site in China — 14 open to participants now, 15 under way, none of them phase 3. Drug-Related Side Effects and Adverse Reactions · China.

Planned enrollment
7th of 20
20,000 · median 6,100
Started
2026
with 1 other
Observational
20 of 53
5 open now
Primary completion
2027-06
later than 12 of 14 live
Registered
53rd of 53
by date
Lead sponsor
3 of 53
Peking University Third Hospital

Among the 53 studies in Drug-Related Side Effects and Adverse Reactions with a site in China, this one is the 7th largest by planned enrollment of the 20 observational ones that give a count, is one of 2 that started in 2026, is one of 20 observational ones, reaches primary completion later than 12 of the 14 other live ones, and was the 53rd registered.

Drug-Related Side Effects and Adverse Reactions

449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Open to participants now

14 of the 53 studies in Drug-Related Side Effects and Adverse Reactions with a site in China are open now. Recruiting first, the newest first:

8 more — sign in →

All 14 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 55 Drug-Related Side Effects and Adverse Reactions studies recruiting now, 37 (67%) set no upper age limit and 15 (27%) stop at 75 or younger; 14 take children under 18; 4 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

This study develops a multi-agent collaborative prediction model to forecast adverse drug reactions using real-world clinical medical records. It validates model performance via evidence-based data and compares decision outputs between the AI model and clinical physicians, aiming to improve early identification of drug adverse events. Only de-identified historical medical data will be analyzed; no new clinical interventions will be conducted, with no additional risks to participants.

Read the detailed description

This observational study first retrospectively collects desensitization cases related to adverse drug reactions to construct a predictive model, and then prospectively enrolls patients to evaluate model efficacy and conduct comparative research with expert blind assessment.

03

Conditions studied

  • Adverse Drug Reactions
  • Clinical Decision Support
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study includes two types of research subjects:

Retrospective de-identified adverse drug reaction (ADR) medical records: A total of 253 ADR consultation cases covering anti-infectives, cardiovascular agents, anti-tumor drugs, central nervous system drugs and digestive system drugs. Each case contains complete medical history, medication records, ADR occurrence process and clinical outcome data, as well as at least one clinically confirmed definite ADR event.

Clinical evaluators: 20 licensed physicians or pharmacists holding intermediate or higher professional titles, with clinical pharmacy practice and regular participation in hospital ADR monitoring and consultation work.

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Inclusion criteria

  • Cases shall involve drug categories including anti-infectives, cardiovascular agents, anti-tumor drugs, central nervous system drugs, digestive system drugs, etc. Each case must contain at least one definite adverse drug reaction (ADR) event, with complete supporting documentation (medical history, medication history, ADR occurrence process, and clinical outcome).

Exclusion criteria

Exclusion Criteria:

  • Cases with incomplete supporting documentation lacking medical history, medication history, ADR occurrence process or clinical outcome.
  • Cases only with suspected or possible ADRs without definite clinical confirmation.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
20,000 participants (estimated)
Patient registry
No

Interventions

  • OtherRetrospective medical record data analysis only, no clinical intervention

    This study only analyzes de-identified historical electronic medical record data to build a multi-agent AI prediction model for adverse drug reactions. No drugs, medical devices, or clinical treatment interventions will be applied to any human subjects.

06

What researchers measure

Primary outcomes

  1. Coverage rate of known ADRs

    Time frame: Up to 8 weeks

  2. Objective question accuracy

    Time frame: Up to 24 weeks

  3. Concordance rate of predicted unknown ADRs

    Time frame: Up to 8 weeks

  4. Expert-rated subjective answer quality

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Subgroup differences in ADR recognition coverage rate

    Time frame: Up to 24 weeks

  2. Inter-rater consistency

    Time frame: Up to 24 weeks

  3. Subgroup differences in answer quality score

    Time frame: Up to 24 weeks

  4. Rater acceptance scale score

    Time frame: Up to 24 weeks

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.

Of 65 non-industry observational studies under Drug-Related Side Effects and Adverse Reactions, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24. This study's planned 12 months is below that.

Counting every sponsor, half of 69 studies reached it within 45 months; a quarter within 24 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Sep 9, 2026
StartActual
Jun 19, 2026
Primary completionEst.
Jun 19, 2027
CompletionEst.
Dec 19, 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07808866
Responsible party
Hongmei Jing (Chief Physician, Peking University Third Hospital) — Principal investigator
First posted
Sep 9, 2026
Start date
Jun 19, 2026
Primary completion
Jun 19, 2027 (estimated)
Completion
Dec 19, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Weilong Zhang
Contact
zhangwl2012@126.com
010-82266782

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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