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Clinical trials are experiments conducted in human volunteers in order to evaluate and compare
- new or existing methods for the diagnosis of preclinical or clinical disease,
- new or existing strategies for the prevention of disease, or
- new or existing agents or regimens (drugs, devices, behaviors) for the treatment of disease.
This website focuses on the proper design, conduct, monitoring, and analysis of clinical trials. The targeted
audience includes both new researchers desiring to learn about general clinical trial
methodology, as well as more advanced clinical trialists seeking information on more specialized techniques
useful in the statistical design of clinical trials.
Our ultimate goal is to promote methodology that would ensure that a clinical trial would produce results that answer an important question in a scientifically credible, statistically precise, economically efficient, and ethical manner. To that end, the web pages at this site include educational modules presenting
- an overview of common clinical trial settings,
- issues that should be considered in the scientific design of a clinical trial,
- methodology for the statistical design of a clinical trial,
- logistical issues that arise during the conduct of the clinical trial, and
- topics meriting special attention during the analysis and interpretation of clinical trial results.
Learning formats will include
- a series of web page tutorials that can be used as a self-guided course in general clinical trial methods,
- recorded lectures (audio and slides) from courses delivered to university, industry, and / or regulatory audiences,
- case studies of representative clinical trials,
- a guide to freely available software that can be used in the statistical design, monitoring, and analysis of clinical trials, and
- notes from presentations and technical reports on advanced methodology.
The web site is meant to be dynamic: incorporating new topics and enhancements as they become of interest to the clinical
trials community. To that end, website visitors are encouraged to submit comments, questions, and suggestions for further content.
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