title: Communication about the risks and benefits of phase I pediatric oncology trials.
abstract: BACKGROUND
  Phase 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.
  
  
  METHODS
  Participants 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.
  
  
  RESULTS
  Risks 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.
  
  
  CONCLUSIONS
  Therapeutic 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.
authors: Department of Pediatrics, Case Western Reserve University and Rainbow Babies and Children's Hospital, 10524 Euclid Ave, Cleveland, OH 44106, USA. Electronic address: rebecca.hazen@uhhospitals.org.
authors: Rebecca A
authors: RA
authors: Hazen
authors: Department of Family Medicine, Case Western Reserve University, 11100 Euclid Ave, Cleveland, OH 44106, USA. Electronic address: sjz@case.edu.
authors: Stephen
authors: S
authors: Zyzanski
authors: St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN 38105-3678, USA. Electronic address: justin.baker@stjude.org.
authors: Justin N
authors: JN
authors: Baker
authors: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, 3333 Burnett Ave, Cincinnati, OH 45229-3026, USA. Electronic address: dennis.drotar@cchmc.org.
authors: Dennis
authors: D
authors: Drotar
authors: Center for Ethics, Humanities, and Spiritual Care, Cleveland Clinic, 9500 Euclid Ave JJ60, Cleveland, OH 44195, USA. Electronic address: kodishe@ccf.org.
authors: Eric
authors: E
authors: Kodish
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D017321:Clinical Trials, Phase I as Topic; D003142:Communication; D005260:Female; D006801:Humans; D007223:Infant; D007258:Informed Consent; D057828:Informed Consent By Minors; D008297:Male; D008495:Medical Oncology; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010290:Parents; D018579:Patient Selection; D011368:Professional-Family Relations; D011788:Quality of Life; D012306:Risk; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents
keywords: Ethics; Informed consent; Phase 1 trials
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