Abstract

Not surprisingly, clinical trials have been critically important to developments in the field of biotechnology. Perhaps less expectedly, the clinical trials of biotechnology products have been critically important to recent developments in the field of clinical trials design, conduct, and analysis. This manuscript explores three examples of biotechnology clinical trials—a trial in sepsis, a trial in fibrinolytics in myocardial infarction, and trials in gene therapy—and highlights their contributions to the theory and practice of clinical research.

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