ArticleContemporary clinical trials2015
Communication about the risks and benefits of phase I pediatric oncology trials.
Article in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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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
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A Systematic Review of Pediatric Phase I Trials in Oncology: Toxicity and Outcomes in the Era of Targeted Therapies.The oncologist · 2020Pooled it
- Advancing the field of communication research in pediatric oncology: A systematic review of the literature analyzing medical dialogue.Pediatric blood & cancer · 2018Pooled it
- Patient and Caregiver Reported Barriers to Cancer Clinical Trial Participation: A Scoping Review.Cancer reports (Hoboken, N.J.) · 2026Article
- The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies.Epidemiologia (Basel, Switzerland) · 2024Article
- Early phase clinical trials in pediatric oncology: Swedish pediatric oncologists' experiences of balancing hope and expectations in life-threatening illnesses.Frontiers in oncology · 2024Article
- What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.BMC medical ethics · 2022Article
- Approaches for Discussing Clinical Trials with Pediatric Oncology Patients and Their Families.Current oncology reports · 2022Review
- Parents' Insights into Pediatric Oncology Phase I Clinical Trials: Experiences from Their Child's Participation.Seminars in oncology nursing · 2021Review
- Communication of Pharmacogenomic test results and treatment plans in pediatric oncology: deliberative stakeholder consultations with parents.BMC palliative care · 2021Article
- Well-Being of Child and Family Participants in Phase 1 Pediatric Oncology Clinical Trials.Oncology nursing forum · 2018Review
- Communication in pediatric oncology: State of the field and research agenda.Pediatric blood & cancer · 2018Review
- Innovations for phase I dose-finding designs in pediatric oncology clinical trials.Contemporary clinical trials · 2016Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
introductionPhase 1 pediatric oncology trials offer only a small chance of direct benefit and may have significant risks and an impact on quality of life. To date, research has not examined discussions of risks and benefits during informed consent conferences for phase 1 pediatric oncology trials. The objective of the current study was to examine clinician and family communication about risks, benefits, and quality of life during informed consent conferences for phase 1 pediatric oncology trials.
methodsParticipants included clinician investigators, parents, and children recruited from 6 sites conducting phase 1 pediatric oncology trials. Eighty-five informed consent conferences were observed and audiotaped. Trained coders assessed discussions of risks, benefits, and quality of life. Types of risks discussed were coded (e.g., unanticipated risks, digestive system risks, and death). Types of benefits were categorized as therapeutic (e.g., discussion of how participation may or may not directly benefit child), psychological, bridge to future trial, and altruism.
resultsRisks and benefits were discussed in 95% and 88% of informed consent conferences, respectively. Therapeutic benefit was the most frequently discussed benefit. The impact of trial participation on quality of life was discussed in the majority (88%) of informed consent conferences.
conclusionTherapeutic benefit, risks, and quality of life were frequently discussed. The range of information discussed during informed consent conferences suggests the need for considering a staged process of informed consent for phase 1 pediatric oncology trials.
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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.