Biostatistics Topics Course, Summer 2009
A clinical trial is a research study on human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find effective treatments and deliver them to people.
With respect to the ethical treatment of research participants, current U.S. regulations require that clinical trials are designed is such a way that "risks to subjects are reasonable in relation to anticipated benefits".
To minimize the risk of participants, most clinical trials are designed sequentially. That is, results are being monitored, and the optimal continuation of the trial - the optimal treatment allocation, dosage, and other conditions - are selected based on the interim analysis. For example, sequential design allows a treatment arm or the entire trial to be stopped early if there is clear evidence of unacceptable adverse effects.
This course will discuss standard sequential statistical methods used in design and analysis of clinical trials. We start by discussing fundamental concepts of clinical trials and introducing Sequential Analysis as a general subject and proceed to study sequential hypothesis testing for treatment comparison, evaluation of probabilities of Type I and Type II errors, sequential methods for binary data and survival data that often appear in clinical research.
This is not meant to be the first course in Statistics. I will assume undergraduate knowledge of Probability and Mathematical Statistics (see prerequisites below).
See http://www.clinicaltrials.gov/ for a more detailed introduction to clinical trials.
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The grade consists of 4 weekly quizzes and a Final Exam.
90-100 % = A, 75-90 % = B, 55-75 % = C