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Updated: Jun 10, 2025

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一个路线图,以改善临床试验中的代表性

Amanda F Petrik1, Nora B Henrikson2, Gloria D Coronado1,3

  • 1Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, United States.

Contemporary clinical trials communications
|October 11, 2024
PubMed
概括

为临床试验招募各种患者,包括代表性不足的少数群体和低收入人群,是可以实现的. 在CAFÉ研究中,多元化和西班牙语参与者的同意率更高,导致了更可概括的健康科学发现.

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Clinical Trials

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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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...
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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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