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分散的临床试验:通过估计框架的透视来考虑科学问题

Rima Izem1, Emmanuel Zuber2, Nadia Daizadeh3

  • 1Novartis Pharma AG, Basel, Switzerland. rima.izem@novartis.com.

Therapeutic innovation & regulatory science
|February 5, 2024
PubMed
概括

分散临床试验 (DCT) 提供了诸如降低患者负担和更广泛的访问等好处. 本研究建议使用ICH E9 (((R1) 估计和框架来战略性地评估DCT超出运营方面的范围.

关键词:
分权化的组成部分是去中心化.估计和属性 估计和属性患者为中心的患者.虚拟的临床试验 虚拟的临床试验

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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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Blinding01:11

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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Randomized Experiments01:13

Randomized Experiments

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Simple randomization
Simple...
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Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
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What are Estimates?01:06

What are Estimates?

It isn't easy to measure a parameter such as the mean height or the mean weight of a population. So, we draw samples from the population and calculate the mean height or mean weight of the individuals in the sample. This sample data acts as a representative measure of the population parameter. These sample statistics are known as estimates. 
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