TY - JOUR
T1 - Bayesian optimal interval design
T2 - A simple and well-performing design for phase i oncology trials
AU - Yuan, Ying
AU - Hess, Kenneth R
AU - Hilsenbeck, Susan G.
AU - Gilbert, Mark R
N1 - Funding Information:
Y. Yuan was supported in part by the NIH under award numbers P50CA098258 and R01CA154591.
Publisher Copyright:
©2016 American Association for Cancer Research.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Despite more than two decades of publications that offer more innovative model-based designs, the classical 3 +3 design remains the most dominant phase I trial design in practice. In this article, we introduce a new trial design, the Bayesian optimal interval (BOIN) design. The BOIN design is easy to implement in a way similar to the 3 + 3 design, but is more flexible for choosing the target toxicity rate and cohort size and yields a substantially better performance that is comparable with that of more complex model-based designs. The BOIN design contains the 3 + 3 design and the accelerated titration design as special cases, thus linking itto established phase I approaches. A numerical study shows that the BOIN design generally outperforms the 3 + 3 design and the modified toxicity probability interval (mTPI) design. The BOIN design is more likely than the 3 + 3 design to correctly select the MTD and allocate more patients to the MTD. Compared with the mTPI design, the BOIN design has a substantially lower risk of overdosing patients and generally a higher probability of correctly selecting the MTD. User-friendly software is freely available to facilitate the application of the BOIN design.
AB - Despite more than two decades of publications that offer more innovative model-based designs, the classical 3 +3 design remains the most dominant phase I trial design in practice. In this article, we introduce a new trial design, the Bayesian optimal interval (BOIN) design. The BOIN design is easy to implement in a way similar to the 3 + 3 design, but is more flexible for choosing the target toxicity rate and cohort size and yields a substantially better performance that is comparable with that of more complex model-based designs. The BOIN design contains the 3 + 3 design and the accelerated titration design as special cases, thus linking itto established phase I approaches. A numerical study shows that the BOIN design generally outperforms the 3 + 3 design and the modified toxicity probability interval (mTPI) design. The BOIN design is more likely than the 3 + 3 design to correctly select the MTD and allocate more patients to the MTD. Compared with the mTPI design, the BOIN design has a substantially lower risk of overdosing patients and generally a higher probability of correctly selecting the MTD. User-friendly software is freely available to facilitate the application of the BOIN design.
UR - http://www.scopus.com/inward/record.url?scp=84988664625&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84988664625&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-16-0592
DO - 10.1158/1078-0432.CCR-16-0592
M3 - Article
C2 - 27407096
AN - SCOPUS:84988664625
SN - 1078-0432
VL - 22
SP - 4291
EP - 4301
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 17
ER -