Multi-Agent collaborative framework for adverse drug reaction prediction: Evidence-Based verification and Human-Machine decision comparative study
NCT ID NCT07808866
First seen Sep 09, 2026 · Last updated Sep 09, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 20,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Peking University Third Hospital
NOT_YET_RECRUITINGBeijing, China
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