Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About Medicines

London School of Economics and Political Science

Status: Not yet enrolling

Conditions: Cancer

Treatments: Other: Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.; Other: Control (standard patient leaflet); Other: Patient leaflet with the EMA's proposed key information section including qualitative statements.

Study type: Interventional

Funder types: Other

Identifiers

NCT07061197

494342

Details and patient eligibility

About

This online randomized controlled trial will evaluate whether adding a key information section to patient information leaflets leads to more accurate expectations and improves participants' understanding. We will test the impact of including quantitative information on drug benefits in addition to qualitative statements, versus including qualitative statements only. Participants will be randomly assigned to one of three groups: (1) a standard patient leaflet that contains no information on drug benefits, (2) a leaflet featuring a key information section that includes qualitative statements about drug benefits, or (3) a leaflet featuring a key information section that includes quantitative information about drug benefits in addition to qualitative statements.

Full description

Currently, European legislation requires that patient information leaflets accompanying all prescription medicines list the adverse effects of the medicine and provide guidance on its safe and appropriate use. In 2025, the European Medicines Agency (EMA) launched a public consultation on a proposal to include a new 'key information section' in the patient leaflets across Europe. A key information section is intended to help users quickly access non-promotional information about both the drug benefits and risks of a drug.

This study aims to evaluate the effect of including information about drug benefits, either qualitatively or both qualitatively and quantitatively, on individuals' expectations of a new cancer drug, using the European patient leaflet.

In this online randomized controlled trial, a nationally representative sample of adults from the United Kingdom will be randomly assigned to 1 of 3 versions of a patient leaflet: (1) the standard patient information leaflet (control), (2) a leaflet with the EMA's proposed key information section containing qualitative statements, or (3) a leaflet with a key information section providing both qualitative and quantitative data on the drug's benefits and harms. The patient leaflet used in the study was for a cancer drug (tivozanib).

The primary outcome is participants' expectations regarding the drug's benefits and harms. Secondary outcomes include participants' understanding of the information, participants perceived magnitude of the drug's benefits and harms, and their satisfaction with the leaflet content.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adults 18 years of age and older,
• Adults fluent in English,
• Adults residing in the United Kingdom (i.e., nationally representative sample of UK adults).

Exclusion critera:

• Participants who do not meet all 3 inclusion criteria.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,100 participants in 3 patient groups, including a placebo group

Control (standard patient leaflet)

Placebo Comparator group

Treatment:

Other: Control (standard patient leaflet)

Patient leaflet with the EMA's proposed key information section including qualitative statements

Experimental group

Treatment:

Other: Patient leaflet with the EMA's proposed key information section including qualitative statements.

Patient leaflet with a key information section providing qualitative and quantitative information

Experimental group

Treatment:

Other: Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.