Concern 736 · Working draft · editorial review in progress

AI in clinical trials

AI-related clinical-trial bias occurs when automated recruitment or monitoring overlooks some participants, misreads their records or measures outcomes unevenly.

Understanding the concern

A matching tool can compare a patient's record with trial criteria and suggest studies worth considering. But missing information may be mistaken for ineligibility, and people with less complete records may be missed. During a trial, monitoring tools can also work differently across devices or participant groups.

Trial-matching research shows promising assistance on defined tasks. It does not establish that an automated pipeline recruits fairly or that a suggested match confirms eligibility. Think of a search filter that helps find candidates but should not silently close the door. Human review, checks across groups and careful handling of health information remain necessary.

An example

A potentially eligible person is never shown to a recruitment team because a key fact is absent from their electronic record.

Illustrative unless identified as a documented case.

Words in plain English

AI
Software that learns patterns from examples or uses rules to perform tasks such as recognizing images or generating text. It can make mistakes and does not understand every situation as a person would.

Evidence and its limits

The source supports patient-to-trial matching, not all monitoring uses. The broader monitoring concern requires tool-specific validation and is not measured by this study.

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Broader frameworks and background

These resources provide context. They do not establish every claim in this concern.

A question to discuss

Who might be missed by this matching process, and how will the team look for them?

Keep track of different views, what needs checking, and any next step in your own discussion notes.

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Principles for the conversation

Before you finish · reflect together

Virtues and principles to consider

Virtues are qualities we practice in how we treat people and make choices. They are not scores for judging someone. Use these ideas to explore what a thoughtful response could look like.

Learning together

Learning together means treating experience as something a group can examine and improve. It values honest feedback over appearing successful.

Agree on a question, try something manageable, and compare what different people observed. Share failures as well as gains. Decide together what the evidence supports and what remains uncertain.

Ask together: What have we learned together that should guide the next step?

Humility

Humility means recognizing the limits of our knowledge and being willing to learn from others. Expertise can be valuable without answering every question.

State where evidence is weak, invite criticism, and listen to people with different experience. Leave room to revise a decision when new information appears.

Ask together: What might we be missing, and who could help us see it?

Truthfulness

Truthfulness means making claims that match the evidence and being clear about what we do not know. It includes correcting mistakes rather than protecting a polished story.

Check sources, label guesses, and distinguish a trial result from a proven benefit. If AI helped produce a claim, someone still needs to take responsibility for checking it.

Ask together: What can we honestly say, and what still needs checking?

Editorial ratings

These are editorial judgments from the register, not measured probabilities or predictions about your situation.

Severity
Serious · 3/5
Likelihood
Documented at scale · 5/5
Time horizon
Now
Register risk score
15
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