Abstract
A design for testing new anticancer agents is proposed such that the initial testing of new agents (phase II trials) is included within the framework of a comparative clinical trial (phase III). Randomization between phase II trials and the treatment groups of the phase III trial enforces consistency of patient selection and evaluation of response criteria. Patients who progress on the phase II trials of the new agents are randomized to one of the treatments of the phase III trial. Design issues, such as sample size and power, and analysis of the proposed design, are discussed. Advantages and disadvantages of the design are illustrated by sample size calculations for a current clinical trial in advanced breast cancer.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 107-118 |
| Number of pages | 12 |
| Journal | Controlled Clinical Trials |
| Volume | 9 |
| Issue number | 2 |
| DOIs | |
| State | Published - 1988 |
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Keywords
- phase II Anticancer agents
- phase III survival comparison
- Randomized design
ASJC Scopus subject areas
- Pharmacology
Cite this
A design for phase II testing of anticancer agents within a phase III clinical trial. / Schaid, Daniel J; Ingle, James N.; Wieand, Sam; Ahmann, David L.
In: Controlled Clinical Trials, Vol. 9, No. 2, 1988, p. 107-118.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A design for phase II testing of anticancer agents within a phase III clinical trial
AU - Schaid, Daniel J
AU - Ingle, James N.
AU - Wieand, Sam
AU - Ahmann, David L.
PY - 1988
Y1 - 1988
N2 - A design for testing new anticancer agents is proposed such that the initial testing of new agents (phase II trials) is included within the framework of a comparative clinical trial (phase III). Randomization between phase II trials and the treatment groups of the phase III trial enforces consistency of patient selection and evaluation of response criteria. Patients who progress on the phase II trials of the new agents are randomized to one of the treatments of the phase III trial. Design issues, such as sample size and power, and analysis of the proposed design, are discussed. Advantages and disadvantages of the design are illustrated by sample size calculations for a current clinical trial in advanced breast cancer.
AB - A design for testing new anticancer agents is proposed such that the initial testing of new agents (phase II trials) is included within the framework of a comparative clinical trial (phase III). Randomization between phase II trials and the treatment groups of the phase III trial enforces consistency of patient selection and evaluation of response criteria. Patients who progress on the phase II trials of the new agents are randomized to one of the treatments of the phase III trial. Design issues, such as sample size and power, and analysis of the proposed design, are discussed. Advantages and disadvantages of the design are illustrated by sample size calculations for a current clinical trial in advanced breast cancer.
KW - phase II Anticancer agents
KW - phase III survival comparison
KW - Randomized design
UR - http://www.scopus.com/inward/record.url?scp=0023879701&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0023879701&partnerID=8YFLogxK
U2 - 10.1016/0197-2456(88)90032-3
DO - 10.1016/0197-2456(88)90032-3
M3 - Article
C2 - 3396362
AN - SCOPUS:0023879701
VL - 9
SP - 107
EP - 118
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
SN - 0197-2456
IS - 2
ER -