Toward improved understanding of the ethical and clinical issues surrounding mandatory research biopsies

Journal of Clinical Oncology

Volumn 31, Issue 1, 2013, Pages 1-2

  Peppercorn, Jeffrey ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; BIOPSY; BONE MARROW BIOPSY; BREAST BIOPSY; CLINICAL TRIAL (TOPIC); DRUG RESEARCH; EDITORIAL; HEALTH CARE QUALITY; HUMAN; INFORMED CONSENT; MOLECULAR MEDICINE; PRIORITY JOURNAL; RESEARCH ETHICS; SAFETY; SKIN BIOPSY; TREATMENT RESPONSE;

BIOMEDICAL RESEARCH; BIOPSY; CLINICAL TRIALS AS TOPIC; HUMANS; INFORMED CONSENT; MEDICAL ONCOLOGY; NEOPLASMS;

EID: 84871780523     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.44.8589     Document Type: Editorial

References (13)

1. Peppercorn J, Shapira I, Collyar D, et al: Ethics of mandatory research biopsy for correlative end points within clinical trials in oncology. J Clin Oncol 28:2635-2640, 2010
2. Olson EM, Lin NU, Krop IE, et al: The ethical use of mandatory research biopsies. Nat Rev Clin Oncol 8:620-625, 2011
3. Gelber RD, Goldhirsch A: Can a clinical trial be the treatment of choice for patients with cancer? J Natl Cancer Inst 80:886-887, 1988
4. Okie S: Access before approval: A right to take experimental drugs? N Engl J Med 355:437-440, 2006
5. Henderson GE, Churchill LR, Davis AM, et al: Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 4:e324, 2007
6. Katz M: Are we asking too much? The challenges of mandatory research biopsies within clinical trials. Presented at the Annual Meeting of the American Society of Clinical Oncology, June 4-8, 2010, Chicago, IL. http://www.asco.org/ ASCOv2/MultiMedia/Virtual+Meeting?&vmview=vm-session-presentations- view&confID=74&sessionID=3286
7. Overman MJ, Modak J, Kopetz S, et al: Use of research biopsies in clinical trials: Are risks and benefits adequately discussed? J Clin Oncol 31:17-22, 2013
8. Gomez-Roca CA, Lacroix L, Massard C, et al: Sequential research-related biopsies in phase I trials: Acceptance, feasibility and safety. Ann Oncol 23:1301-1306, 2012
9. Dowlati A, Haaga J, Remick SC, et al: Sequential tumor biopsies in early phase clinical trials of anticancer agents for pharmacodynamic evaluation. Clin Cancer Res 7:2971-2976, 2001
10. Agulnik M, Oza AM, Pond GR, et al: Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents. J Clin Oncol 24:4801-4807, 2006
11. Miller M: Phase I cancer trials: A collusion of misunderstanding. Hastings Cent Rep 30:34-43, 2000
12. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358:1772-1777, 2001
13. Tomamichel M, Sessa C, Herzig S, et al: Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients. Ann Oncol 6:363-369, 1995