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Clinical Trial Designs in Amyotrophic Lateral Sclerosis: Does One Design Fit All?

Katharine A Nicholson1, Merit E Cudkowicz, James D Berry

  • 1Massachusetts General Hospital, Department of Neurology, Neurological Clinical Research Institute, 165 Cambridge Street, Suite 600, Boston, MA, 02114, USA, knicholson@partners.org.

Neurotherapeutics : the Journal of the American Society for Experimental Neurotherapeutics
|February 22, 2015
PubMed

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
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