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Pioneering Patient-Specific Approaches for Precision Surgery Using Imaging and Virtual Reality
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Pioneering Patient-Specific Approaches for Precision Surgery Using Imaging and Virtual Reality

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The role of clinical trials in the development of novel surgical techniques

Heidi Nelson1, Anne-Marie Boller

  • 1Mayo Clinic, Division of Colon and Rectal Surgery, Rochester, Minnesota, USA. nelsonh@mayo.edu

Journal of Surgical Oncology
|December 18, 2007
PubMed

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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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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...