Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives

Cancer

Volumn 116, Issue 13, 2010, Pages 3244-3250

  Yap, Tsiao Yi ^a   Yamokoski, Amy D ^a   Hizlan, Sabahat ^a   Zyzanski, Stephen J ^b   Angiolillo, Anne L ^c   Rheingold, Susan R ^d   Baker, Justin N ^e   Kodish, Eric D ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

^b CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^d CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^e ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

Author keywords

Ethics; Informed consent; Pediatric oncology; Phase 1 trials; Physicians' perspectives

Indexed keywords

ADULT; ARTICLE; CHILD CARE; CHILD PARENT RELATION; CHILDHOOD CANCER; CLINICAL DECISION MAKING; CLINICAL PRACTICE; CLINICAL RESEARCH; FEMALE; FEMALE PHYSICIAN; HUMAN; INFORMED CONSENT; MALE; MEDICAL ETHICS; NORMAL HUMAN; PRIORITY JOURNAL; SELF REPORT;

ADULT; ATTITUDE OF HEALTH PERSONNEL; CLINICAL TRIALS, PHASE I AS TOPIC; FEMALE; HEALTH CARE SURVEYS; HUMANS; INFORMED CONSENT; MALE; MEDICAL ONCOLOGY; NEOPLASMS; PARENTAL CONSENT; PEDIATRICS; PHYSICIAN'S PRACTICE PATTERNS; PHYSICIAN'S ROLE; PHYSICIAN-PATIENT RELATIONS; QUESTIONNAIRES;

EID: 77954246263     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.25158     Document Type: Article

References (20)

1. Smith M, Bernstein M, Bleyer WA, et al. Conduct of phase I trials in children with cancer. J Clin Oncol. 1998; 16:966-978. (Pubitemid 28108729)
2. Kodish E. Informed consent for pediatric research: is it really possible? J Pediatr. 2003; 142:89-90.
3. Daugherty CK, Banik DM, Janish L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: a survey interview study of 144 advanced cancer patients. IRB. 2000; 22:6-14.
4. Oberman M, Frader J. Dying children and medical research: access to clinical trials as benefit and burden. Am J Law Med. 2003; 29:301-317. (Pubitemid 39530596)
5. Hinds PS, Pritchard M, Harper J. End-of-life research as a priority for pediatric oncology. J Pediatr Oncol Nurs. 2004; 21:175-179.
6. Gordon EJ, Daugherty CK. "Hitting you over the head": oncologists' disclosure of prognosis to advanced cancer patients. Bioethics. 2003; 17:142-168.
7. Kodish E, Post SG. Oncology and hope. J Clin Oncol 1995; 13:1817.
8. Miller M. Phase I cancer trials. A collusion of misunderstanding. Hastings Cent Rep. 2000; 30:34-43.
9. Groopman JE. A strategy for hope: a commentary on necessary collusion. J Clin Oncol. 2005; 23:3151-3152. (Pubitemid 46224141)
10. Kodish E. Pediatric ethics and early-phase childhood cancer research: conflicted goals and the prospect of benefit. Account Res. 2003; 10:17-25.
11. Kodish ED, Pentz RD, Noll RB, Ruccione K, Buckley J, Lange BJ. Informed consent in the children's cancer group: results of preliminary research. Cancer. 1998; 82:2467-2481. (Pubitemid 28283455)
12. Simon C, Eder M, Raiz P, Zyzanski S, Pentz R, Kodish ED. Informed consent for pediatric leukemia research: clinician perspectives. Cancer. 2001; 92:691-700.
13. Denzin NK, Lincoln YS. Handbook of Qualitative Research. 2nd ed. Thousand Oaks, CA: Sage; 2000.
14. Denzin NK, Lincoln YS. Collecting and Interpreting Qualitative Materials. Thousand Oaks, CA: Sage; 1998.
15. Estlin EJ, Cotterill S, Pratt CB, Pearson AD, Bernstein M. Phase I trials in pediatric oncology: perceptions of pediatricians from the United Kingdom children's cancer study group and the pediatric oncology group. J Clin Oncol. 2000; 18:1900-1905. (Pubitemid 30261927)
16. Helft PR, Hlubocky F, Wen M, Daugherty CK. Associations among awareness of prognosis, hopefulness, and coping in patients with advanced cancer participating in phase I clinical trials. Support Care Cancer. 2003; 11:644-651.
17. Daugherty CK, Ratain MJ, Siegler M. Pushing the envelope: informed consent in phase I trials. Ann Oncol. 1995; 6:321-323.
18. Gilligan C. In a Different Voice: Psychological Theory and Women's Development. Cambridge, MA: Harvard University Press; 1993.
19. Sherwin S. No Longer Patient: Feminist Ethics and Health Care. Philadelphia, PA: Temple University Press; 1992.
20. Horng S, Grady C. Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB. 2003; 25:11-16.