Ethical Framework for Including Research Biopsies in Oncology Clinical Trials: American Society of Clinical Oncology Research Statement

Laura A. Levit, Jeffrey M. Peppercorn, Alda L. Tam, Jonathan M. Marron, Debra J Mathews, Kathryn Levit, Nancy Roach, Mark J. Ratain

Research output: Contribution to journalArticle

Abstract

In contrast to clinical biopsies, where tissue is collected to inform patient care, research biopsies are performed for scientific purposes to potentially enhance understanding of the biologic bases of cancer and drug action, thereby improving diagnosis and treatment, but they may offer no direct benefit to participants and have known risks. The widespread use of research biopsies that do not have the potential to directly benefit participants has come under scrutiny, with critics raising ethical concerns related to the adequacy of participant protections, informed consent, and participant understanding of the risks and benefits, as well as the scientific impact of research biopsies on drug development and treatment. This manuscript presents the American Society of Clinical Oncology's (ASCO's) ethical framework for incorporation of research biopsies in trials. The framework provides guidance on the circumstances to include optional and mandatory biopsies, as well as provides recommendations to stakeholders on necessary steps for improving the conduct of research biopsies overall.

Original languageEnglish (US)
Pages (from-to)2368-2377
Number of pages10
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume37
Issue number26
DOIs
StatePublished - Sep 10 2019

Fingerprint

Clinical Trials
Biopsy
Research
Medical Oncology
Informed Consent
Pharmaceutical Preparations
Patient Care
Therapeutics
Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Ethical Framework for Including Research Biopsies in Oncology Clinical Trials : American Society of Clinical Oncology Research Statement. / Levit, Laura A.; Peppercorn, Jeffrey M.; Tam, Alda L.; Marron, Jonathan M.; Mathews, Debra J; Levit, Kathryn; Roach, Nancy; Ratain, Mark J.

In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 37, No. 26, 10.09.2019, p. 2368-2377.

Research output: Contribution to journalArticle

Levit, Laura A. ; Peppercorn, Jeffrey M. ; Tam, Alda L. ; Marron, Jonathan M. ; Mathews, Debra J ; Levit, Kathryn ; Roach, Nancy ; Ratain, Mark J. / Ethical Framework for Including Research Biopsies in Oncology Clinical Trials : American Society of Clinical Oncology Research Statement. In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2019 ; Vol. 37, No. 26. pp. 2368-2377.
@article{b6dada80258242f387b606eda2f605d3,
title = "Ethical Framework for Including Research Biopsies in Oncology Clinical Trials: American Society of Clinical Oncology Research Statement",
abstract = "In contrast to clinical biopsies, where tissue is collected to inform patient care, research biopsies are performed for scientific purposes to potentially enhance understanding of the biologic bases of cancer and drug action, thereby improving diagnosis and treatment, but they may offer no direct benefit to participants and have known risks. The widespread use of research biopsies that do not have the potential to directly benefit participants has come under scrutiny, with critics raising ethical concerns related to the adequacy of participant protections, informed consent, and participant understanding of the risks and benefits, as well as the scientific impact of research biopsies on drug development and treatment. This manuscript presents the American Society of Clinical Oncology's (ASCO's) ethical framework for incorporation of research biopsies in trials. The framework provides guidance on the circumstances to include optional and mandatory biopsies, as well as provides recommendations to stakeholders on necessary steps for improving the conduct of research biopsies overall.",
author = "Levit, {Laura A.} and Peppercorn, {Jeffrey M.} and Tam, {Alda L.} and Marron, {Jonathan M.} and Mathews, {Debra J} and Kathryn Levit and Nancy Roach and Ratain, {Mark J.}",
year = "2019",
month = "9",
day = "10",
doi = "10.1200/JCO.19.01479",
language = "English (US)",
volume = "37",
pages = "2368--2377",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "26",

}

TY - JOUR

T1 - Ethical Framework for Including Research Biopsies in Oncology Clinical Trials

T2 - American Society of Clinical Oncology Research Statement

AU - Levit, Laura A.

AU - Peppercorn, Jeffrey M.

AU - Tam, Alda L.

AU - Marron, Jonathan M.

AU - Mathews, Debra J

AU - Levit, Kathryn

AU - Roach, Nancy

AU - Ratain, Mark J.

PY - 2019/9/10

Y1 - 2019/9/10

N2 - In contrast to clinical biopsies, where tissue is collected to inform patient care, research biopsies are performed for scientific purposes to potentially enhance understanding of the biologic bases of cancer and drug action, thereby improving diagnosis and treatment, but they may offer no direct benefit to participants and have known risks. The widespread use of research biopsies that do not have the potential to directly benefit participants has come under scrutiny, with critics raising ethical concerns related to the adequacy of participant protections, informed consent, and participant understanding of the risks and benefits, as well as the scientific impact of research biopsies on drug development and treatment. This manuscript presents the American Society of Clinical Oncology's (ASCO's) ethical framework for incorporation of research biopsies in trials. The framework provides guidance on the circumstances to include optional and mandatory biopsies, as well as provides recommendations to stakeholders on necessary steps for improving the conduct of research biopsies overall.

AB - In contrast to clinical biopsies, where tissue is collected to inform patient care, research biopsies are performed for scientific purposes to potentially enhance understanding of the biologic bases of cancer and drug action, thereby improving diagnosis and treatment, but they may offer no direct benefit to participants and have known risks. The widespread use of research biopsies that do not have the potential to directly benefit participants has come under scrutiny, with critics raising ethical concerns related to the adequacy of participant protections, informed consent, and participant understanding of the risks and benefits, as well as the scientific impact of research biopsies on drug development and treatment. This manuscript presents the American Society of Clinical Oncology's (ASCO's) ethical framework for incorporation of research biopsies in trials. The framework provides guidance on the circumstances to include optional and mandatory biopsies, as well as provides recommendations to stakeholders on necessary steps for improving the conduct of research biopsies overall.

UR - http://www.scopus.com/inward/record.url?scp=85071788224&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85071788224&partnerID=8YFLogxK

U2 - 10.1200/JCO.19.01479

DO - 10.1200/JCO.19.01479

M3 - Article

C2 - 31343905

AN - SCOPUS:85071788224

VL - 37

SP - 2368

EP - 2377

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 26

ER -