ABSTRACT
I. Cancer Treatment Progress.................................................................. 115
II. Benefit to Risk Ratio ........................................................................... 116
III. Trial Endpoints .................................................................................... 117
IV. Phase I Clinical Trial........................................................................... 118
V. Phase II Clinical Trial ......................................................................... 120
VI. Phase III Clinical Trial ........................................................................ 121
A. General Consideration .................................................................. 121
B. Randomization .............................................................................. 122
C. Stratification .................................................................................. 123
D. Size of the Trial ............................................................................ 123
E. Data Analysis ................................................................................ 126
F. Interim Analyses ........................................................................... 128
VII. Trial Report.......................................................................................... 129
Acknowledgments ........................................................................................... 130
References........................................................................................................ 131
In the 1930s, less than 20% of cancer patients were alive 5 years after diagnosis.
In the 1940s, the figure was about 25%, and in the 1960s it was about 33%. Today
about 40% of cancer patients will be alive 5 years after diagnosis. If we compared
with a similar control population, then the 5 year relative survival rate was 48.9%
for patients diagnosed in 1974-1976 and 49.8% for patients diagnosed during
the period 1980-1985.
