| 活動說明 |
1. 講題:「Statistical Consideration in the Design of Clinical
Trials」
2. 講員: 鄒小蕙博士
3. 時間地點: 2/26(三) 12:10-13:10 陽明大學醫學二館221室
4. 課程摘要
Pharmaceutical development is a time-consuming, very
expensive, and highly risky process. Most of the budget
for research and development goes to clinical trials in
clinical development. Therefore, there are urgent needs
of statistical strategies to enhance clinical research
design, reduce the required sample size, shorten the
duration of drug development, and increase the success
rate of new drug development. In this presentation, I
will introduce some clinical trials designs and provide
some statistical considerations in clinical trials such
as bridging studies, multi-regional clinical trials and
biosimilar clinical trials. Some new statistical
methodologies in designing those clinical trials will be
proposed and sample size consideration will be addressed.
Numerical examples will be given to evaluate the
performance of the proposed method. Examples from a
papulopustular acne study, an antidepressant study in
patients with depression, and a study in patients with
human growth hormone deficiency will be used to
demonstrate our methodologies. |
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