Evaluating FDA's Proposed Patient Medication Information Handout

Completed · Not applicable

Conditions studied: Knowledge, Attitude

In brief

The goal of this study is to assess how useful the proposed one-page FDA-template PMI is to potential users. The main questions it aims to answer are: How does the proposed one-page FDA-template PMI compare with the current drug information insert in terms of usefulness and comprehension? and How does the proposed one-page FDA-template PMI compare with a revision adding drug benefit information? Participants will randomized to review one of three patient medication information sheets and then asked questions related to usefulness and comprehension.

Key facts

Study ID

NCT06320808

Run by

Carnegie Mellon University

People needed

330

Starts

2024-03-03

Expected to finish

2025-02-06

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• US geographic location
• 18-45 years of age
• assigned female sex at birth

You may not qualify if…

• <18 years of age
• > 45 years of age
• assigned a sex other than female at birth

Where it is running

• Carnegie Mellon University — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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