The ethics of phase 0 oncology trials

Emily Abdoler, Holly Taylor, David Wendler

Research output: Contribution to journalArticle

Abstract

Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

Original languageEnglish (US)
Pages (from-to)3692-3697
Number of pages6
JournalClinical Cancer Research
Volume14
Issue number12
DOIs
StatePublished - Jun 15 2008

Fingerprint

Ethics
Clinical Trials
Research Subjects
Terminally Ill
United States Food and Drug Administration
Research
Pharmaceutical Preparations
Neoplasms
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

The ethics of phase 0 oncology trials. / Abdoler, Emily; Taylor, Holly; Wendler, David.

In: Clinical Cancer Research, Vol. 14, No. 12, 15.06.2008, p. 3692-3697.

Research output: Contribution to journalArticle

Abdoler, Emily ; Taylor, Holly ; Wendler, David. / The ethics of phase 0 oncology trials. In: Clinical Cancer Research. 2008 ; Vol. 14, No. 12. pp. 3692-3697.
@article{32d37a90dfa349cbae2ab8f9693d4048,
title = "The ethics of phase 0 oncology trials",
abstract = "Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.",
author = "Emily Abdoler and Holly Taylor and David Wendler",
year = "2008",
month = "6",
day = "15",
doi = "10.1158/1078-0432.CCR-08-0876",
language = "English (US)",
volume = "14",
pages = "3692--3697",
journal = "Clinical Cancer Research",
issn = "1078-0432",
publisher = "American Association for Cancer Research Inc.",
number = "12",

}

TY - JOUR

T1 - The ethics of phase 0 oncology trials

AU - Abdoler, Emily

AU - Taylor, Holly

AU - Wendler, David

PY - 2008/6/15

Y1 - 2008/6/15

N2 - Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

AB - Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

UR - http://www.scopus.com/inward/record.url?scp=52449090857&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=52449090857&partnerID=8YFLogxK

U2 - 10.1158/1078-0432.CCR-08-0876

DO - 10.1158/1078-0432.CCR-08-0876

M3 - Article

C2 - 18559585

AN - SCOPUS:52449090857

VL - 14

SP - 3692

EP - 3697

JO - Clinical Cancer Research

JF - Clinical Cancer Research

SN - 1078-0432

IS - 12

ER -