PMID- 2702835
OWN - NLM
STAT- MEDLINE
DCOM- 19890512
LR  - 20220410
IS  - 0197-2456 (Print)
IS  - 0197-2456 (Linking)
VI  - 10
IP  - 1
DP  - 1989 Mar
TI  - Optimal two-stage designs for phase II clinical trials.
PG  - 1-10
AB  - The primary objective of a phase II clinical trial of a new drug or regimen is to 
      determine whether it has sufficient biological activity against the disease under 
      study to warrant more extensive development. Such trials are often conducted in a 
      multi-institution setting where designs of more than two stages are difficult to 
      manage. This paper presents two-stage designs that are optimal in the sense that 
      the expected sample size is minimized if the regimen has low activity subject to 
      constraints upon the size of the type 1 and type 2 errors. Two-stage designs 
      which minimize the maximum sample size are also determined. Optimum and "minimax" 
      designs for a range of design parameters are tabulated. These designs can also be 
      used for pilot studies of new regimens where toxicity is the endpoint of 
      interest.
FAU - Simon, R
AU  - Simon R
AD  - Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Control Clin Trials
JT  - Controlled clinical trials
JID - 8006242
SB  - IM
MH  - Drug Evaluation/*methods
MH  - Humans
MH  - Neoplasms/*drug therapy
MH  - *Research Design
MH  - Statistics as Topic
EDAT- 1989/03/01 00:00
MHDA- 1989/03/01 00:01
CRDT- 1989/03/01 00:00
PHST- 1989/03/01 00:00 [pubmed]
PHST- 1989/03/01 00:01 [medline]
PHST- 1989/03/01 00:00 [entrez]
AID - 0197-2456(89)90015-9 [pii]
AID - 10.1016/0197-2456(89)90015-9 [doi]
PST - ppublish
SO  - Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.