TY  - CHAP
M1  - Book, Section
TI  - Chapter 37. Statistical Design and Analysis of Phase III Clinical Trials
A1  - Costantino, Joseph P.
A1  - Anderson, Stewart
A1  - Yothers, Greg
A2  - Kuerer, Henry M.
PY  - 2010
T2  - Kuerer's Breast Surgical Oncology
AB  - The  purpose  of  this  chapter  is  to  describe  key  aspects  of  the  design  and  analysis  of  phase  III  clinical  trials  focusing  on  the  treatment  of  breast  cancer.  Phase  III  clinical  trials  are  1  of  5  basic  hierarchical  phases  of  human  research  activity  designed  to  ascertain  information  regarding  the  biological  processing,  safety,  and  efficacy  of  a  new  treatment.1,2  Details  regarding  phase  III  trials  are  provided  later  in  the  chapter.  To  provide  a  perspective  from  which  to  understand  the  relative  importance  of  the  type  of  information  that  is  gained  from  a  phase  III  clinical  trial,  before  we  begin  our  presentation  on  the  design  and  analysis  of  phase  III  trials,  we  present  a  synopsis  of  all  of  the  different  phases  of  clinical  trial  research.  We  use  the  term  "new  treatment"  as  a  general  term  to  refer  to  the  use  of  one  or  several  methods  for  treating  a  disease  or  condition  with  a  new  surgical  technique,  a  new  medical  device,  or  a  new  form  of  chemical,  physical,  or  biological  agent.  
SN  - 
PB  - The McGraw-Hill Companies
CY  - New York, NY
Y2  - 2024/04/19
UR  - accesssurgery.mhmedical.com/content.aspx?aid=6411936
ER  -