ABSTRACT
I. Introduction............................................................................................ 79
II. Clinical Trial Design ............................................................................. 80
A. Treatment Comparison (Control) ................................................... 80
B. Masked Evaluation (Blinding)........................................................ 81
C. Randomization ................................................................................ 82
III. Statistical Design ................................................................................... 84
IV. Phases of Clinical Trials........................................................................ 86
A. Phase I ............................................................................................. 86
B. Phase II............................................................................................ 87
C. Phase III .......................................................................................... 87
D. Phase IV and Phase V .................................................................... 88
V. Study Protocol ....................................................................................... 88
References.......................................................................................................... 89
Designing clinical trials of pharmaceutical products shares many characteristics
with other types of scientific study. General principles of experimental design
applied to other types of scientific studies also apply to clinical trials, i.e., to
reduce experimental error in the data collection and to avoid bias in the decision
making. The unique characteristic of clinical trials is that the experimental units
are human beings, commonly called subjects — and usually sick ones at that.
Modern clinical trials must be designed in such a way that the participants can be
well informed about the conduct, purpose, and reasonable risks and benefits of
the trial, and that the welfare of each participant remains more important than
carrying out the trial as designed. The Declaration of Helsinki,
