What is the difference between non-inferiority and equivalence trials?

What is the difference between non-inferiority and equivalence trials?

Non-inferiority trials aim to show that the new drug is no worse than standard treatment. Equivalence trials aim to show the new treatment is no better and no worse. This is the definition of what would be the minimum important difference between the treatments.

How do you find the sample size for a non-inferiority study?

To calculate the sample size, we can use Table 5, which gives calculated sample sizes for various standardised non-inferiority limits (δNI = dNI/σ). The percentage mean differences are given for the case where it is anticipated that there may be a non-zero difference between treatments, that is, µA−µB = 0.

How can you differentiate between superiority and non-inferiority clinical trial?

In comparison studies with a current therapy, non-inferiority is used to demonstrate that the new therapy provides at least the same benefit to the patient. Superiority trials are always used when comparisons are made to placebo or vehicle treatments.

How does testing for non-inferiority test for equivalence?

Equivalence can be shown using a ‘two one-sided test’ (TOST) procedure. This is a simple extension of the non-inferiority test described above, with a ‘superiority’ margin (+dNI) and the inferiority margin (–dNI). To conclude equivalence, the appropriate CI must lie completely within the range (–dNI, +dNI) (see Fig.

What is equivalence study?

In an equivalence trial, the statistical test aims at showing that two treatments are not too different in characteristics, where “not too different” is defined in a clinical manner. Finally, in a non-inferiority trial, the aim is to show that an experimental treatment is not (much) worse than a standard treatment.

What is an equivalence design?

Noninferiority designs are a one-sided test used to determine if a novel intervention is no worse than a standard intervention. Equivalence designs, a two-sided test, pose a similar question, but also allow for the possibility that the novel intervention is no better than the standard one.

How do you determine a sample size?

Starts here2:46How to calculate Sample Size – YouTubeYouTube

How do you read a non-inferiority margin?

The calculated CI does not know whether its purpose is to judge superiority or non-inferiority. If it sits wholly above zero, then it has shown superiority. If it sits wholly above -Δ, then it has shown non-inferiority. A non-inferiority trial can have five possible types of outcomes as depicted in Figure 2.

What is equivalence clinical trial?

What is an equivalence trial?

Equivalence trials compare a new treatment for a disease or condition with an existing treatment—usually the standard one. Classic randomised controlled trials aim to establish whether a new treatment or therapeutic regimen is better than an existing one or placebo.

Can you prove superiority in a non-inferiority trial?

In a non-inferiority trial, the focus is on the lower bound margin, what happens at the upper end is not of primary concern in this type of trial design. One can also declare superiority in a non-inferiority trial if the lower limit of CI of the new treatment is above the non-inferiority margin and above zero.

What is equivalence margin?

The equivalence margin defines a range of values for which the efficacies are “close enough” to be considered equivalent. In practical terms, the margin is the maximum clinically acceptable difference that one is willing to accept in return for the secondary benefits of the new therapy.

What is the difference between a non-inferiority and equivalence trial?

It is also important to note, as has been inferred from the above, that a non-inferiority trial is essentially a one sided equivalence trial or conversely an equivalence trial can be described as two one sided tests (TOST). Which hypothesis you use depends entirely on the question your trial is addressing.

What is the difference between superiority and non-inferiority?

Of these three comparisons, the non-inferiority has the largest range of successful trial outcomes (equivalence or superiority). Thus a calculated sample size for a non-inferiority trial is usually the smallest of the three hypothesis. The superiority comparison is a subset of the non-inferiority and will have a sample size

What is the difference between equivalence and nonequivalence studies?

In contrast, the goal of equivalence studies is to demonstrate equivalency, so that is where the burden of proof rests (Table 1). If the evidence in favor of equivalence is not strong enough, nonequivalence cannot be ruled out.

What is the difference between superiority and bioequivalence trials?

Failure to demonstrate superiority over vehicle suggests that the drug is not effective. Superiority trials are also used for marketing purposes (“our drug is better than your drug” studies). Bioequivalence trials are used to show that a new treatment is identical (within an acceptable range) to a current treatment.

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