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CONSORT 2025声明:随机试验报告的更新指南

Sally Hopewell1, An-Wen Chan2, Gary S Collins3

  • 1Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford UK.

Lancet (London, England)
|April 17, 2025
PubMed
概括

更新的"报告试验综合标准 (CONSORT) 2025"声明提高了随机试验报告的质量. 它包括新的项目,修订和开放科学部分,以便更清晰,更透明的试验出版物.

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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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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
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Blinding

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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Types of Reports III: Telephone and Verbal Reports

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Telephone Orders
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