CancerNCT06997185
Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
A study testing Statement communicating uncertainty with a single arm trial, Statement communicating uncertainty with limited study duration and Statement communicating uncertainty with a limited study population in people with Cancer, run by London School of Economics and Political Science at 1 site in United States.
Trial summary
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and 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?
- Statement communicating uncertainty with a single arm trial, Statement communicating uncertainty with limited study duration and Statement communicating uncertainty with a limited study population
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 States
Who cannot join
- Participants who do not meet each of the 3 inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, Massachusetts, 02139
Avi Cherla, 617-201-1718, a.j.cherla@lse.ac.uk
Avi Cherla
About this study
This nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.
Read the detailed description
Many newer cancer drugs are approved before uncertainties with their underlying clinical trial evidence have been adequately studied, in turn making it difficult to accurately determine the drug's benefits and harms. Prescription drug information rarely communicates these uncertainties. In a nationally representative sample of US adults, this study will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.
In the pre-intervention phase, participants will be given information about a hypothetical new drug approved for the treatment of non-small cell lung cancer. Participants will be asked how likely they would be to take the drug, and how certain they are that the drug will work. Participants will then be randomized to 1 of 5 statements about a source of uncertainty with the drug's evidence that were based on the most common sources of uncertainties with new cancer drugs that are cited in FDA approval decisions: (1) single-arm trial designs, (2) limited study populations (i.e., generalizability of clinical trial evidence), and (3) limited study durations (i.e., long-term benefits and harms). Two additional uncertainties were also included that are frequently mentioned in the scientific literature: (4) the use of unvalidated surrogate endpoints to support new cancer drug approvals, and (5) uncertain treatment effect size (i.e., the magnitude of therapeutic benefit). The post-intervention questions will re-assess participants' decision making and perceptions of uncertainty, as well as their understanding of the uncertainty communicated in the statement.
- Conditions
- Cancer
- Being tested
- Statement communicating uncertainty with a single arm trial, Statement communicating uncertainty with limited study duration, Statement communicating uncertainty with a limited study population, Statement communicating uncertainty with an unvalidated surrogate endpoint, Statement communicating uncertainty with treatment effect size
- Keywords
- Cancer, Uncertainty, 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.
Statement communicating uncertainty with a single arm trialOther
Because Zenova has not been compared to other treatments, it is unknown if Zenova is better, the same, or worse than other treatments for non-small cell lung cancer.
Statement communicating uncertainty with limited study durationOther
Since patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown.
Statement communicating uncertainty with a limited study populationOther
Zenova has not been studied in patients similar to Alex (patients with her race and ethnicity). It is unknown whether Zenova will work and what harms it will have for patients like her.
Statement communicating uncertainty with an unvalidated surrogate endpointOther
Zenova has only been shown to shrink the size of tumors. It is unknown whether Zenova improves how patients feel or how long they live.
Statement communicating uncertainty with treatment effect sizeOther
It is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova.
| Study group | Role | What they receive |
|---|---|---|
| Single arm trial | Experimental | Not described Receives: Other: Statement communicating uncertainty with a single arm trial |
| Limited study duration (long-term benefits and harms) | Experimental | Not described Receives: Other: Statement communicating uncertainty with limited study duration |
| Limited study population (generalizability) | Experimental | Not described Receives: Other: Statement communicating uncertainty with a limited study population |
| Unvalidated surrogate endpoint | Experimental | Not described Receives: Other: Statement communicating uncertainty with an unvalidated surrogate endpoint |
| Treatment effect size (magnitude of benefit) | Experimental | Not described Receives: Other: Statement communicating uncertainty with treatment effect size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decisions
"Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely are you to take the new drug, Zenova?"
4-point Likert scale for decision: very likely; somewhat likely; somewhat unlikely; very unlikely.
Measured: 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention.
Understanding
Please answer rate your agreement with the following statements. Zenova works better than other treatments for non-small cell lung cancer Zenova's longer-term benefits and harms are well known Zenova has been studied in patients that are similar to Alex (race and ethnicity) Zenova improves how patients feel or how long they live Zenova has a very large benefit for patients with non-small cell lung cancer
5-point Likert scale for understanding: strongly disagree; somewhat disagree; neither disagree or agree; somewhat agree; strongly agree.
Measured: 15-minute survey. Assessed post-intervention.
Secondary outcomes (1)
Change in perception of uncertainty
"How certain are you that Zenova will work for Alex?"
4-point Likert scale for perception of uncertainty: very uncertain; somewhat uncertain; somewhat certain; very certain.
Measured: 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start9 May 2025
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School / Harvard Pilgrim Health Care Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997185
- Sponsor's protocol ID
- 540788
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cherla A, Wagner AK, Woloshin S, Davis C, Bourgeois FT, Mossialos E, Naci H. Communicating Uncertainties About the Benefits and Risks of New Cancer Drugs: Two Randomized Clinical Trials. JAMA Intern Med. 2026 Oct 12. doi: 10.1001/jamainternmed.2026.4969. Online ahead of print.
PubMed 42862585
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
- ClinicalTrials.gov ID
- NCT06997185
- Acronym / sponsor ID
- 540788
- Conditions
- Cancer
- Keywords
- Cancer, Uncertainty, Prescription drug information
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- Harvard Medical School / Harvard Pilgrim Health Care Institute
- Study start
- 9 May 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 May 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 nationally representative randomized survey of US adults will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.
Detailed description
Many newer cancer drugs are approved before uncertainties with their underlying clinical trial evidence have been adequately studied, in turn making it difficult to accurately determine the drug's benefits and harms. Prescription drug information rarely communicates these uncertainties. In a nationally representative sample of US adults, this study will evaluate the effect of using brief statements to communicate different sources of uncertainty about the benefits and harms of new cancer drugs on participants' decisions and understanding.
In the pre-intervention phase, participants will be given information about a hypothetical new drug approved for the treatment of non-small cell lung cancer. Participants will be asked how likely they would be to take the drug, and how certain they are that the drug will work. Participants will then be randomized to 1 of 5 statements about a source of uncertainty with the drug's evidence that were based on the most common sources of uncertainties with new cancer drugs that are cited in FDA approval decisions: (1) single-arm trial designs, (2) limited study populations (i.e., generalizability of clinical trial evidence), and (3) limited study durations (i.e., long-term benefits and harms). Two additional uncertainties were also included that are frequently mentioned in the scientific literature: (4) the use of unvalidated surrogate endpoints to support new cancer drug approvals, and (5) uncertain treatment effect size (i.e., the magnitude of therapeutic benefit). The post-intervention questions will re-assess participants' decision making and perceptions of uncertainty, as well as their understanding of the uncertainty communicated in the statement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single arm trial | Experimental | Other: Statement communicating uncertainty with a single arm trial |
| Limited study duration (long-term benefits and harms) | Experimental | Other: Statement communicating uncertainty with limited study duration |
| Limited study population (generalizability) | Experimental | Other: Statement communicating uncertainty with a limited study population |
| Unvalidated surrogate endpoint | Experimental | Other: Statement communicating uncertainty with an unvalidated surrogate endpoint |
| Treatment effect size (magnitude of benefit) | Experimental | Other: Statement communicating uncertainty with treatment effect size |
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 States
Key exclusion criteria (1 listed)
- Participants who do not meet each of the 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 |
|---|---|---|
| Statement communicating uncertainty with a single arm trialBecause Zenova has not been compared to other treatments, it is unknown if Zenova is better, the same, or worse than other treatments for non-small cell lung cancer. | Other | Single arm trial |
| Statement communicating uncertainty with limited study durationSince patients given Zenova were followed for a short time, the longer-term benefits and harms of taking Zenova are unknown. | Other | Limited study duration (long-term benefits and harms) |
| Statement communicating uncertainty with a limited study populationZenova has not been studied in patients similar to Alex (patients with her race and ethnicity). It is unknown whether Zenova will work and what harms it will have for patients like her. | Other | Limited study population (generalizability) |
| Statement communicating uncertainty with an unvalidated surrogate endpointZenova has only been shown to shrink the size of tumors. It is unknown whether Zenova improves how patients feel or how long they live. | Other | Unvalidated surrogate endpoint |
| Statement communicating uncertainty with treatment effect sizeIt is unknown whether patients with non-small cell lung cancer will notice an improvement with Zenova. | Other | Treatment effect size (magnitude of benefit) |
Primary outcome
Change in decisions
Time frame: 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention.
"Imagine you were Alex and diagnosed with non-small cell lung cancer. How likely are you to take the new drug, Zenova?" 4-point Likert scale for decision: very likely; somewhat likely; somewhat unlikely; very unlikely.
Understanding
Time frame: 15-minute survey. Assessed post-intervention.
Please answer rate your agreement with the following statements. Zenova works better than other treatments for non-small cell lung cancer Zenova's longer-term benefits and harms are well known Zenova has been studied in patients that are similar to Alex (race and ethnicity) Zenova improves how patients feel or how long they live Zenova has a very large benefit for patients with non-small cell lung cancer 5-point Likert scale for understanding: strongly disagree; somewhat disagree; neither disagree or agree; somewhat agree; strongly agree.
1 secondary outcome
Change in perception of uncertainty
Time frame: 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 42862585Cherla A, Wagner AK, Woloshin S, Davis C, Bourgeois FT, Mossialos E, Naci H. Communicating Uncertainties About the Benefits and Risks of New Cancer Drugs: Two Randomized Clinical Trials. JAMA Intern Med. 2026 Oct 12. doi: 10.1001/jamainternmed.2026.4969. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statement communicating uncertainty with a single arm trial, Statement communicating uncertainty with limited study duration and Statement communicating uncertainty with a limited study population in people with Cancer, run by London School of Economics and Political Science at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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 States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avi Cherla (16172011718, a.j.cherla@lse.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in decisions (time frame: 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06997185, which also lists 1 linked publication.
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 30 May 2025.