What must research subjects be told regarding the results of completed randomized trials?

IRB Ethics and Human Research

Volumn 26, Issue 3, 2004, Pages 8-10

  Markman, Maurie ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PACLITAXEL;

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DECISION MAKING; ETHICS; FEMALE; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; METHODOLOGY; OVARY TUMOR; PATERNALISM; PERSONNEL; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; RESEARCH SUBJECT; STANDARD; SURVIVAL; TREATMENT OUTCOME;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

DECISION MAKING; DISCLOSURE; ETHICS COMMITTEES, RESEARCH; FEMALE; HUMANS; INFORMED CONSENT; OVARIAN NEOPLASMS; PACLITAXEL; PATERNALISM; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 6044257267     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563750     Document Type: Article

References (8)

1. 45 CFR 46. Protection of Human Subjects. General requirements for informed consent, 46.116(b)(5).
2. Markman M, Liu PY, Wilczynski S, et al. Phase 3 randomized trial of 12 versus 3 months of single-agent paclitaxel in patients with advanced ovarian cancer who attained a clinically defined complete response to platinum/paclitaxel-based chemotherapy. A Southwest Oncology Group and Gynecologic Oncology Group trial. Journal of Clinical Oncology 2003;21:2460-2465.
3. Covens A, Carey M, Bryson P, et al. Systematic review of first-line chemotherapy for newly diagnosed postoperative patients with stage II, III, and IV epithelial ovarian cancer. Gynecologic Oncology 2002;85:71-80.
4. See ref. 3, Covens 2002; Markman M, Bookman M. Second-line treatment of ovarian cancer. The Oncologist 2000;5:26-35.
5. See ref. 3, Covens 2002.
6. See ref. 2, Markman et al. 2003.
7. Smith MA, Ungerleider RS, Korn EL, et al. Role of independent data-monitoring committees in randomized trials sponsored by the National Cancer Institute. Journal of Clinical Oncology 1997;15:2736-2743.
8. Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. Journal of Clinical Oncology 2003;21:1404-1411.