CancerNCT07061197
Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About Medicines
A study testing Patient leaflet with the EMA's proposed key information section including qualitative statements. and Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms. in people with Cancer, run by London School of Economics and Political Science at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Patient leaflet with the EMA's proposed key information section including qualitative statements. and Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2025to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Participants who do not meet all 3 inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Economics and Political Science
London
About this study
Official title: Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About New Medicines: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- Patient leaflet with the EMA's proposed key information section including qualitative statements., Control (standard patient leaflet), Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.
- Keywords
- Cancer, Prescription drug information
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient leaflet with the EMA's proposed key information section including qualitative statements.Other
The standard patient leaflet supplemented with a key information section. This section included qualitative descriptions of the goal of treatment, the main benefits, contraindications, and the most serious side effects. The content was designed to reflect the EMA's proposed format for improving the patient information leaflet.
Control (standard patient leaflet)Other
The standard patient information leaflet for a recently approved cancer drug, tivozanib (Fotivda), obtained electronically from the EMA website. The standard patient information does not contain structured benefit information.
Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.Other
The standard patient leaflet, supplemented with a key information section including quantitative data on the drug's main benefits and side effects, presented in a summary table format. This section provided structured information about the indication and goal of treatment, how the drug was studied (the comparator treatment and number of patients enrolled in the clinical trial that supported the drug's approval), and data on the drug's benefits and side effects.
| Study group | Role | What they receive |
|---|---|---|
| Control (standard patient leaflet) | Placebo comparator | Not described Receives: Other: Control (standard patient leaflet) |
| Patient leaflet with the EMA's proposed key information section including qualitative statements | Experimental | Not described Receives: 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 | Not described Receives: Other: Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expectations
Multiple choice questions assessing expectations about the benefits of tivozanib, a cancer drug approved by the European Medicines Agency.
For example, "does Fotivda cure advanced kidney cancer?" Measured on a 4 point-Likert scale: definitely yes; probably yes; probably no; definitely no.. See attached protocol.
Measured: Assessed during 15-minute survey.
Secondary outcomes (3)
Understanding
Multiple choice questions assessing participants understanding of the information in the patient leaflet (e.g., what is Fotivda used for?)
Each question includes several response options, with 1 correct answer per item. See attached protocol.
Measured: Assessed during 15-minute survey.
Perceived magnitude of benefits and harms
Multiple choice questions assessing participants perceived magnitude of the drug's benefits and harms (e.g., Overall, how large are the benefits of Fotivda?)
Likert scales vary depending on the question. See attached protocol.
Measured: Assessed during 15-minute survey
Satisfaction with information in the patient leaflet
Multiple choice questions assessing participants' satisfaction with information included in the patient leaflet (e.g., ease of finding and understanding information).
Likert scales vary depending on the question. See attached protocol.
Measured: Assessed during 15-minute survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Jul 2025
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061197
- Sponsor's protocol ID
- 494342
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Communicating Structured Benefit and Harm Information in European Patient Leaflets on Individuals' Expectations About New Medicines: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07061197
- Acronym / sponsor ID
- 494342
- Conditions
- Cancer
- Keywords
- Cancer, Prescription drug information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,101 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (standard patient leaflet) | Placebo comparator | Other: Control (standard patient leaflet) |
| Patient leaflet with the EMA's proposed key information section including qualitative statements | Experimental | 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 | Other: Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Participants who do not meet all 3 inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient leaflet with the EMA's proposed key information section including qualitative statements.The standard patient leaflet supplemented with a key information section. This section included qualitative descriptions of the goal of treatment, the main benefits, contraindications, and the most serious side effects. The content was designed to reflect the EMA's proposed format for improving the patient information leaflet. | Other | Patient leaflet with the EMA's proposed key information section including qualitative statements |
| Control (standard patient leaflet)The standard patient information leaflet for a recently approved cancer drug, tivozanib (Fotivda), obtained electronically from the EMA website. The standard patient information does not contain structured benefit information. | Other | Control (standard patient leaflet) |
| Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms.The standard patient leaflet, supplemented with a key information section including quantitative data on the drug's main benefits and side effects, presented in a summary table format. This section provided structured information about the indication and goal of treatment, how the drug was studied (the comparator treatment and number of patients enrolled in the clinical trial that supported the drug's approval), and data on the drug's benefits and side effects. | Other | Patient leaflet with a key information section providing qualitative and quantitative information |
Primary outcome
Expectations
Time frame: Assessed during 15-minute survey.
Multiple choice questions assessing expectations about the benefits of tivozanib, a cancer drug approved by the European Medicines Agency. For example, "does Fotivda cure advanced kidney cancer?" Measured on a 4 point-Likert scale: definitely yes; probably yes; probably no; definitely no.. See attached protocol.
3 secondary outcomes
Understanding
Time frame: Assessed during 15-minute survey.
Perceived magnitude of benefits and harms
Time frame: Assessed during 15-minute survey
Satisfaction with information in the patient leaflet
Time frame: Assessed during 15-minute survey.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient leaflet with the EMA's proposed key information section including qualitative statements. and Patient leaflet with a key information section providing both qualitative and quantitative information on drug benefits and harms. in people with Cancer, run by London School of Economics and Political Science at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expectations (time frame: Assessed during 15-minute survey.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.