Clinical trial NCT06997185: Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
Official title: Communicating Uncertainties Associated With the Benefits and Risks of New Cancer Drugs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Uncertainty
Prescription drug information
Lead sponsor: London School of Economics and Political Science
Sponsor class: OTHER
Collaborators: name: Harvard Medical School / Harvard Pilgrim Health Care Institute
First posted: 2025-05-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age and older
* Adults fluent in English
* Adults residing in the United States

Exclusion Criteria:

* Participants who do not meet each of the 3 inclusion criteria

Primary outcomes:
measure: Change in decisions
timeFrame: 15-minute survey. Change in decisions is assessed by participants answers to the question pre- and post-intervention.
measure: Understanding
timeFrame: 15-minute survey. Assessed post-intervention.
Secondary outcomes:
measure: Change in perception of uncertainty
timeFrame: 15-minute survey. Change in perception of uncertainties is assessed by participants answers to the question pre- and post-intervention.
Other outcomes:
measure: Perceived importance of knowing about uncertainty
timeFrame: 15-minute survey. Assessed post-intervention.
Locations:
city: Boston
country: United States
facility: Harvard Medical School and Harvard Pilgrim Health Care Institute
state: Massachusetts
Study officials:
References: