Statistics of clinical trials

  • Thread starter straycat
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In summary: Without correction, there is a higher chance of obtaining false positives, leading to incorrect conclusions about the efficacy of the drugs. Therefore, it is important to correct for multiple comparisons in order to make accurate and informed decisions about which drugs to use.
  • #1
straycat
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I've been thinking about when to correct for multiple comparisons, especially in the context of clinical trials.

Consider the following situations:

1. Company X-1 does a clinical trial on Compound A-1, and finds that it does in fact have clinical efficacy, with p value < 0.05.

2. Company X-1 does a clinical trial on 20 compounds, A-1 through A-20, and finds that one of them has clinical efficacy with p value < 0.05, and 19 don't (without correction for multiple comparisons).

3. Twenty companies, X-1 through X-20, independently discover and do clinical trials on 20 different compounds (X-i tests A-i, i = 1,...,20). One of the compounds turns out to demonstrate efficacy with p value < 0.05, 19 don't. (without correction for multiple comparisons).

So here's my question: in which of the above scenarios should we correct for multiple comparisons? Or asked another way: does the evidence support the use of none, some, or all of the above three drugs?

David

http://en.wikipedia.org/wiki/Multiple_comparisons
 
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  • #2
_problemIn all three scenarios, it is recommended to correct for multiple comparisons, as this will allow you to more accurately determine which of the drugs have clinical efficacy. This can be done by using a Bonferroni correction or a False Discovery Rate (FDR) procedure. These methods help to reduce the risk of false positives and provide a more reliable result.
 
  • #3
It is important to consult with a healthcare professional or a statistician for specific guidance on when to correct for multiple comparisons in clinical trials. However, here are some general considerations:

1. In scenario 1, where a single compound (A-1) is being tested, it is appropriate to use a p-value of < 0.05 as an indicator of significant clinical efficacy, without correction for multiple comparisons.

2. In scenario 2, where 20 compounds are being tested, it is important to correct for multiple comparisons to avoid false positives. This can be done using methods such as Bonferroni correction or false discovery rate control.

3. In scenario 3, where multiple companies are independently testing different compounds, it is also important to correct for multiple comparisons to avoid false positives. This can be done by considering the overall evidence from all 20 compounds, rather than just looking at individual p-values.

It is also worth considering the potential consequences of false positives and false negatives in clinical trials. In some cases, it may be more important to avoid false positives (i.e. claiming a compound is effective when it is not) than false negatives (i.e. missing a potentially effective compound). This should also be taken into account when deciding whether to correct for multiple comparisons.

Ultimately, the decision to correct for multiple comparisons should be based on the specific research question and the potential consequences of false results. It is important to carefully consider these factors and consult with experts before making a decision.
 

What is the purpose of conducting clinical trials?

The purpose of conducting clinical trials is to test the safety and effectiveness of new drugs, treatments, or medical procedures before they are approved for use in the general population. This helps to ensure that patients receive the best possible care and that healthcare providers have evidence-based information to guide their treatment decisions.

What is the difference between observational studies and randomized controlled trials?

Observational studies are used to observe and analyze data from individuals who are already being treated in a certain way, while randomized controlled trials involve randomly assigning participants to either an experimental group receiving the new treatment or a control group receiving a standard treatment or placebo. Randomized controlled trials are considered the gold standard for evaluating the effectiveness of new treatments.

How are participants selected for clinical trials?

Participants for clinical trials are selected based on specific criteria, such as age, gender, medical history, and the condition being studied. This helps to ensure that the results of the trial will be applicable to the target population. Participants also go through a thorough screening process to ensure they meet the necessary requirements and do not have any underlying health conditions that could affect the results.

What is the purpose of blinding in a clinical trial?

Blinding, also known as masking, is a method used in clinical trials to prevent bias and influence in the results. This can be done through single blinding, where either the participants or the researchers are unaware of which group they are in, or double blinding, where both the participants and researchers are unaware. Blinding helps to ensure that the results of the trial are objective and not influenced by expectations or preferences of either the participants or researchers.

How are the results of clinical trials analyzed?

The results of clinical trials are analyzed using statistical methods to determine the effectiveness of the treatment being studied. This involves comparing the outcomes of the treatment group to the control group and taking into account any potential confounding factors. The results are then interpreted and used to inform decisions about the safety and effectiveness of the treatment.

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