Clinical Trial Plain Language Summary Writer

Turn clinical trial results into a patient-friendly plain language summary with balanced outcomes, safety notes, and review-ready wording.

Prompt Template

You are a medical writer specializing in patient-friendly research communication. Draft a plain language summary for [clinical trial/study name] intended for [patients, caregivers, advocacy groups, or the public].

Study details: [condition, intervention, comparator, phase, trial design]
Participant profile: [age range, inclusion criteria, geography, sample size]
Main question: [what the study was trying to find out]
Key results: [primary endpoint, secondary endpoints, important numbers, confidence intervals if available]
Safety findings: [common side effects, serious adverse events, discontinuations]
Limitations: [small sample, short follow-up, missing groups, uncertainty]
Tone and reading level: [grade level, empathetic, neutral, hopeful but cautious]
Required review constraints: [sponsor style guide, regulator requirements, no promotional claims, citations]

Write:
1. **One-paragraph overview**
2. **Why the study was done**
3. **Who took part**
4. **What happened during the study**
5. **What the results showed** using plain language and simple numbers
6. **What side effects or risks were seen**
7. **What the results may mean** without overstating certainty
8. **Limitations and open questions**
9. **Glossary** for technical terms
10. **Reviewer checklist** for scientific accuracy, balance, and compliance

Do not give medical advice. Flag claims that need clinician, sponsor, or regulatory review.

Example Output

Plain Language Summary: Example Asthma Study

**Overview:** This study looked at whether an inhaled medicine could help adults with moderate asthma have fewer symptom flare-ups compared with a placebo inhaler. The study included 420 adults and followed them for 24 weeks.

What did the study find?

People who received the study medicine had fewer asthma flare-ups on average. About 18 out of 100 people in the study medicine group had a flare-up, compared with 29 out of 100 people in the placebo group. This means the medicine may help some people reduce flare-ups, but it did not remove the risk entirely.

Safety

The most common side effects were throat irritation, headache, and cough. Serious side effects were uncommon in both groups. Anyone considering treatment options should discuss personal risks and benefits with a qualified healthcare professional.

Limitations

The study lasted 24 weeks, so it does not answer questions about long-term use. The results may not apply to children or to people with severe asthma who were not included.

**Needs review:** Endpoint wording, adverse event rates, and any comparison claims should be checked against the final clinical study report.

Tips for Best Results

  • 💡Use absolute numbers alongside percentages so patients can understand scale.
  • 💡Avoid promotional language like 'breakthrough' unless it appears in approved materials.
  • 💡Separate what the study found from what it may mean in practice.
  • 💡Keep a review checklist for medical, legal, and regulatory sign-off.