ArticlePloS one2017
Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01772511 (BrUOG 274), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.
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.
BrUOG 274: Do Patients Participating In Oncology Clinical Trials Understand the Informed Consent Form?
Who cites it
23 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.PloS one · 2024Pooled it
- Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023Pooled it
- The reality of informed consent: empirical studies on patient comprehension-systematic review.Trials · 2021Pooled it
- Video-enhanced informed consent improves patient comprehension in reverse total shoulder arthroplasty: a randomized controlled trial.JSES international · 2026Article
- Artificial blood-hope and the challenges to combat tumor hypoxia for anti-cancer therapy.Medical & biological engineering & computing · 2025Review
- Assessment of readability of informed consent forms of gynecologic cancer clinical trials: A (Potential) barrier to enrollment?Gynecologic oncology reports · 2025Article
- Informed consent: Navigating the bioethical complexities of clinical research.Bioinformation · 2025Article
- Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study.JMIR formative research · 2024Article
- Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.Frontiers in medicine · 2024Article
- Public Awareness of Medical Research Terminology in Japan, and the Accuracy of Physicians' Predictions regarding that Awareness.Asian bioethics review · 2023Article
- Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms.JTO clinical and research reports · 2023Article
- The Development of the Oncology Center of Excellence Patient-Friendly Language Glossary of Oncology Clinical Trial Terms.The oncologist · 2023Article
- Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.BMC medical ethics · 2023Article
- Article
- Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials.International journal of radiation oncology, biology, physics · 2020Article
- Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear.The oncologist · 2020Article
- The perceived severity of a disease and the impact of the vocabulary used to convey information: using Rasch scaling in a simulated oncological scenario.Patient preference and adherence · 2018Article
- Assessment of the understanding of informed consent including participants' experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research.HRB open research · 2018Article
- The effects of presenting oncologic information in terms of opposites in a medical context.Patient preference and adherence · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.
methodsWe evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.
resultsFifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38).
conclusionsMany participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.
trial registrationClinicaltrials.gov NCT01772511.
Indexed as
Identifiers
What OpenQuestion holds
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.