AI can be useful when you have approved clinical trial information that needs to become a first draft for patients. It is a less useful starting point when the study team is still deciding what the material should say, important information is missing, or nobody is available to check the result.
Before choosing a tool, consider the task. Are you simplifying established information, organizing it into a familiar format, or asking the system to resolve questions that require clinical judgment? That distinction helps determine where AI can save work and where it may create more.
Use AI to Create a First Draft From Established Information
A lay protocol synopsis or patient information sheet can be a reasonable starting point when the source material, audience, and document structure are clearly defined. AI can help organize information, suggest simpler wording, and produce a draft for an experienced writer to review.
Start with one document type and an agreed template. Provide the relevant approved sources, specify which information must appear, and instruct the tool to flag gaps rather than fill them with assumptions. Reviewers should be able to trace statements back to the source.
The practical test is whether this approach reduces the effort needed to produce an acceptable document, including corrections and approval.
Use AI to Suggest Clearer Language, Then Check the Meaning
AI can offer alternatives to technical terminology, shorten complicated sentences, and reorganize information around patient questions. These suggestions are useful when someone familiar with the study checks that the revised wording preserves the original meaning.
For example, changing “you may need additional blood tests” to “you will have regular blood tests” alters both certainty and expectations about the schedule. The simpler sentence needs correction even if it sounds natural.
Ask reviewers to check accuracy before polishing tone. Then consider whether patients and caregivers can understand what participation involves, what remains uncertain, and where to ask questions.
Hold Off When the Source Cannot Answer the Question
If visit requirements are unclear, support arrangements are unconfirmed, or source documents conflict, resolve those issues before asking AI to explain them to patients. A fluent draft can make an unresolved question harder to notice.
The same applies when the intended audience or purpose is undefined. A recruitment handout and an informed consent document need different levels of detail, even when they describe the same study.
Before drafting, agree on:
Who will read the material.
What the reader needs to understand or do.
Which sources govern the content.
Who will resolve missing or conflicting information.
These decisions give both the writer and the AI tool a clearer assignment.
Keep Decisions About Risks, Benefits, and Participation With Qualified People
AI can help draft an explanation of established information about risks and potential benefits. Qualified reviewers still need to judge whether that explanation is accurate, balanced, and appropriate for its purpose.
Be especially careful with wording that could imply a treatment will work, make participation sound easier than it is, or suggest that a person qualifies for a study. Those judgments cannot be settled by how convincing the generated text sounds.
Likewise, written materials should support conversations with patients. Questions about personal suitability, individual concerns, or whether to participate need an appropriate human contact.
Hold Off If Review Would Be an Afterthought
AI drafting needs a defined review process before the first document is generated. If the team cannot identify who will check the source, assess completeness, and approve the final material, faster drafting will simply create a queue of unchecked content.
Begin with a small, controlled test using an approved tool and permitted source materials. Compare the full effort with the existing process, including drafting, corrections, patient or caregiver feedback where practical, and the required approval steps.
Expand only when the results show that the approach helps produce clear, accurate materials with a manageable review burden. That gives teams a practical basis for deciding where AI belongs.
Continue the Conversation at SCOPE Summit Europe
Join colleagues at SCOPE Summit Europe, October 13–14 in Barcelona, next week to explore AI implementation, patient engagement, and operational readiness. Bring your questions about where AI can help and how to introduce it into everyday clinical trial work.
Explore the program and register here.