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Randomized clinical trials for new surgical operations: square peg in a round hole?

Joel D Cooper1

  • 1Hospital of the University of Pennsylvania, Division of Thoracic Surgery, Philadelphia, PA 19104, USA. joel.cooper@uphs.upenn.edu

The Journal of Thoracic and Cardiovascular Surgery
|September 21, 2010
PubMed
Abstract

No abstract available in 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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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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