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 language | English (US) |
|---|---|
| Pages (from-to) | 3692-3697 |
| Number of pages | 6 |
| Journal | Clinical Cancer Research |
| Volume | 14 |
| Issue number | 12 |
| DOIs | |
| State | Published - Jun 15 2008 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
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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 journal › Article
}
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.
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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 -