ArticleJournal of cancer education : the official journal of the American Association for Cancer Education2025
Cancer Survivors' and Caregivers' Understanding of FDA Accelerated Approval Disclosures.
Article in Journal of cancer education : the official journal of the American Association for Cancer Education, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- FDA Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites: Testing Presence, Prominence, and Wording.Therapeutic innovation & regulatory science · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
The US Food and Drug Administration (FDA)'s accelerated approval pathway is intended to facilitate and expedite development and review for prescription drugs that treat serious or life-threatening illnesses such as cancer. Three elements of this pathway are often disclosed on prescription drug websites for oncology prescription drugs: the basis for the drug's approval, that some clinical benefits are unknown, and that confirmatory trials are ongoing. To assess their retention and understanding of these elements, we randomly assigned 202 cancer survivors and 199 caregivers to view a website for a fictitious acute lymphoblastic leukemia prescription drug with one of four accelerated approval disclosures. All disclosures stated, "In a clinical trial, Altisol returned blood counts to normal." We randomly assigned participants to the presence or absence of an "unknown outcomes" disclosure: "However, we currently do not know if Altisol helps people live longer or feel better." We also randomly assigned participants to the presence or absence of a "confirmatory-trials" disclosure: "We continue to study Altisol in clinical trials to learn more about Altisol's benefits." Participants noticed the disclosures, recognizing the three elements when asked. Regardless of whether participants saw the confirmatory-trials disclosure, participants agreed that more data is needed to learn about the drug's efficacy. The unknown-outcomes disclosure increased comprehension across a wide range of measures. These results suggest that an accelerated approval disclosure (in particular, a statement about unknown outcomes) can help patients and caregivers understand a prescription drug's benefits, which can be critical for their participation in treatment decisions.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.