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Page 1 on 54DEMONSTRATION STUDY OF THE INTEREST OF THE MEDTRUM A7+ TOUCHCARE PATCH PUMP VERSUS INSULET OMNIPOD PATCH PUMP Interventional study protocol Final version 1.3 of 13/05/2020 IDRCB : 2019A0256651

How to fill out a randomized controlled non-inferiority

How to fill out a randomized controlled non-inferiority

1. Define the research question and hypotheses.
2. Identify the population and sample size needed for the study.
3. Randomly assign participants to either the treatment group or the control group.
4. Ensure that both groups are similar at baseline to eliminate bias.
5. Administer the treatment to the active group and a standard treatment or placebo to the control group.
6. Determine a non-inferiority margin based on clinical relevance.
7. Collect data on primary and secondary outcomes.
8. Analyze data using appropriate statistical methods to compare outcomes between groups.
9. Interpret results, focusing on whether the treatment is not inferior to the control within the defined margin.
10. Report findings, including limitations and implications for practice.

Who needs a randomized controlled non-inferiority?

1. Researchers designing clinical trials to compare a new treatment with an existing one.
2. Healthcare providers looking for evidence on treatment effectiveness.
3. Regulatory agencies assessing the approval of new interventions that are similar to existing options.
4. Patients seeking alternative treatment options that are proven to be at least as effective as current therapies.

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What is a randomized controlled non-inferiority?

A randomized controlled non-inferiority trial is a type of clinical trial designed to demonstrate that a new treatment is not worse than an existing treatment by more than a specified margin, while randomly assigning participants to different treatment groups.

Who is required to file a randomized controlled non-inferiority?

Researchers and sponsors of clinical trials intending to prove that a new treatment is non-inferior to a standard treatment must file for a randomized controlled non-inferiority trial.

How to fill out a randomized controlled non-inferiority?

Filling out a randomized controlled non-inferiority trial typically involves defining the research question, specifying the non-inferiority margin, detailing the methodology, including participant selection criteria, randomization procedures, and statistical analysis plans, and submitting the trial protocol to regulatory authorities.

What is the purpose of a randomized controlled non-inferiority?

The purpose of a randomized controlled non-inferiority trial is to show that the new treatment is at least as effective as the existing treatment, which may provide an alternative option that is safer, more convenient, or less expensive.

What information must be reported on a randomized controlled non-inferiority?

Information that must be reported includes the study design, participant demographics, intervention details, the non-inferiority margin, outcome measures, and results, including statistical analyses and confidence intervals.