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Study ConsentOfficial Title: Telemedicine for Reach, Education, Access, and Treatment Ongoing (Treason) StudyClinicalTrials.gov ID (NCT number): NCT04107935Consent Date: 05 August 2020Page 1 of 1CONSENT

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Define the primary endpoint for the trial, ensuring it is clinically relevant and can measure non-inferiority.

02

Determine the non-inferiority margin, which is the largest clinically acceptable difference between the new treatment and the standard treatment.

03

Randomly assign participants to either the new treatment group or the standard treatment group.

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Collect and analyze data on the primary endpoint for both groups.

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Use statistical methods to determine if the new treatment is non-inferior to the standard treatment.

Who needs a non-inferiority trial of?

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Researchers developing a new treatment that aims to show it is not worse than current standard treatment.

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Regulatory bodies requiring evidence of non-inferiority before approving a new treatment.

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Healthcare professionals looking to compare the efficacy of different treatments in clinical practice.

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What is a non-inferiority trial of?

A non-inferiority trial is a type of clinical trial designed to show that a new treatment is not worse than an existing treatment by a specified margin.

Who is required to file a non-inferiority trial of?

Researchers and pharmaceutical companies conducting clinical trials are required to file a non-inferiority trial.

How to fill out a non-inferiority trial of?

A non-inferiority trial is filled out by following the protocol outlined in the study design, including enrollment criteria, randomization, data collection, and statistical analysis.

What is the purpose of a non-inferiority trial of?

The purpose of a non-inferiority trial is to demonstrate that a new treatment is not clinically worse than an existing treatment by a predefined margin.

What information must be reported on a non-inferiority trial of?

Information that must be reported on a non-inferiority trial includes study design, participant demographics, treatment arms, outcomes, adverse events, and statistical analysis.

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