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Glossary Term
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Non-Inferiority Trials

Definition

Non-inferiority trials are clinical trials designed to demonstrate that a new treatment or intervention is not worse than an existing standard treatment by more than a specified margin. These trials aim to establish that the new treatment is at least as effective as the current treatment, but not necessarily better. Non-inferiority trials are often used when it is ethically or practically difficult to establish superiority, such as in situations where the existing treatment is already highly effective.

Relevance to the MedTech Industry

In MedTech, non-inferiority trials are used to compare new medical devices, procedures, or drugs against a current standard to show that they provide similar benefits in terms of safety and efficacy. These trials are crucial when introducing new treatments or technologies that are expected to offer other advantages, such as fewer side effects, lower costs, or easier administration, without compromising on therapeutic outcomes.

Additional Information & Related Terms

Key Features of Non-Inferiority Trials

  1. Margin of Non-Inferiority:

    • A predefined margin is established to define the maximum acceptable difference between the new and existing treatment. This margin is critical for interpreting trial results and ensuring that the new treatment is sufficiently similar to the current standard.

    • Example: A margin of 5% may be set for the difference in efficacy between a new drug and an existing drug, meaning that the new drug’s effectiveness should not be more than 5% worse.

  2. Statistical Significance:

    • The trial must demonstrate that the new treatment’s effect is not worse than the standard treatment by more than the pre-established margin. This requires statistical methods to assess the upper bound of the difference between the two treatments.

  3. Comparative Design:

    • Non-inferiority trials involve direct comparison between the new treatment and the established treatment, often in a randomized controlled trial (RCT) design, to ensure that the comparison is fair and that confounding factors are minimized.

  4. Primary Outcome:

    • The primary outcome of a non-inferiority trial is typically the difference in efficacy (or other relevant clinical outcomes) between the new treatment and the standard. This outcome is carefully defined before the trial begins.


Related Terms

  • Randomized Controlled Trial (RCT): Non-inferiority trials often use a randomized controlled trial design to minimize bias and ensure that the comparison between treatments is fair and scientifically valid.

  • Clinical Outcome Measures: These are the outcomes that are measured to determine the effectiveness of a treatment in a non-inferiority trial, such as survival rates, symptom relief, or other relevant metrics.

  • Superiority Trials: Unlike non-inferiority trials, superiority trials aim to prove that one treatment is more effective than another. Non-inferiority trials may be used when it is not possible or ethical to demonstrate superiority.

  • Equivalence Trials: These are closely related to non-inferiority trials, but they seek to show that two treatments have virtually identical effects, whereas non-inferiority trials show that the new treatment is not worse by more than a certain margin.

  • FDA 21 CFR Part 820: The FDA regulations for medical device manufacturers, which outline the quality control and clinical trial requirements, including the use of non-inferiority trials for regulatory approval.

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