RT Book, Section
A1 Huang, Xuelin
A1 Qiao, Wei
A1 Xia, Fang
A1 Lin, E
A1 Zhu, Liang
A1 Ning, Jing
A2 Kantarjian, Hagop M.
A2 Wolff, Robert A.
A2 Rieber, Alyssa G.
SR Print(0)
ID 1190840750
T1 Statistical Designs for Oncology Clinical Trials
T2 The MD Anderson Manual of Medical Oncology, 4e
YR 2022
FD 2022
PB McGraw Hill Education
PP New York, NY
SN 9781260467642
LK accessmedicine.mhmedical.com/content.aspx?aid=1190840750
RD 2024/04/24
AB KEY  CONCEPTSDose  selection  by  a  phase  I/II  trial  should  be  based  on  efficacy  rather  than  the  maximum  tolerated  dose  (MTD),  among  dose  levels  with  acceptable  toxicities.A  response-adaptive  randomization  (RAR)  schema  must  control  covariate  imbalance  between  the  treatment  arms  to  guarantee  valid  comparison  results  between  them.A  personalized  RAR  is  used  to  assign  each  individual  to  the  treatment  arm  that  fits  them  best  based  on  their  biomarkers.An  efficient  RAR  accounts  for  both  tumor  response  and  survival.An  innovative  statistical  design  for  target  therapies  is  proposed  to  consider  both  the  overall  effects  and  effects  for  an  unknown  sensitive  subset  whose  signature  is  to  be  identified  from  the  ongoing  trial.A  new  enrichment  design  selectively  enrolls  sensitive  patients  during  the  trial  while  keeping  updating  the  selection  criteria  for  sensitive  patients  as  the  trial  proceeds.