TY - JOUR
T1 - Phase II clinical trial design
T2 - Methods in translational research from the genitourinary committee at the Eastern Cooperative Oncology Group
AU - Gray, Robert
AU - Manola, Judith
AU - Saxman, Scott
AU - Wright, John
AU - Dutcher, Jan
AU - Atkins, Michael
AU - Carducci, Michael
AU - See, William
AU - Sweeney, Christopher
AU - Liu, Glenn
AU - Stein, Mark
AU - Dreicer, Robert
AU - Wilding, George
AU - DiPaola, Robert S.
PY - 2006/4/1
Y1 - 2006/4/1
N2 - Given the increase in novel agents and difficulty with planning and completing many phase III studies, various phase II trial design options should be considered to more effectively guide phase III trial plans. The need for novel phase II trial designs has increased, given the number of novel molecular targeted therapies now available for testing, an abundance of cytostatic agents, and limited resources to conduct phase III studies for all interesting agents or combinations. This review will focus on options for phase II trial designs. We review randomized phase II designs with placebo control, randomized selection designs, and randomized discontinuation designs. As agents become available for testing in the clinic, the strengths and weaknesses of different phase II trial designs should be considered to optimize a trial development plan that guides phase III trial decisions more effectively.
AB - Given the increase in novel agents and difficulty with planning and completing many phase III studies, various phase II trial design options should be considered to more effectively guide phase III trial plans. The need for novel phase II trial designs has increased, given the number of novel molecular targeted therapies now available for testing, an abundance of cytostatic agents, and limited resources to conduct phase III studies for all interesting agents or combinations. This review will focus on options for phase II trial designs. We review randomized phase II designs with placebo control, randomized selection designs, and randomized discontinuation designs. As agents become available for testing in the clinic, the strengths and weaknesses of different phase II trial designs should be considered to optimize a trial development plan that guides phase III trial decisions more effectively.
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U2 - 10.1158/1078-0432.CCR-05-1136
DO - 10.1158/1078-0432.CCR-05-1136
M3 - Review article
C2 - 16609005
AN - SCOPUS:33646239403
SN - 1078-0432
VL - 12
SP - 1966
EP - 1969
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 7 I
ER -