What is intention to treat in clinical trials?

Intention-to-treat analysis is a method for analyzing results in a prospective randomized study where all participants who are randomized are included in the statistical analysis and analyzed according to the group they were originally assigned, regardless of what treatment (if any) they received.

What does intent to treat mean in research?

From Wikipedia, the free encyclopedia. In medicine an intention-to-treat (ITT) analysis of the results of an experiment is based on the initial treatment assignment and not on the treatment eventually received.

Why is per protocol analysis used?

While an analysis according to the ITT principle aims to preserve the original randomization and to avoid potential bias due to exclusion of patients, the aim of a per-protocol (PP) analysis is to identify a treatment effect which would occur under optimal conditions; i.e. to answer the question: what is the effect if …

How does per protocol analysis affect intention to treat?

In addition, it usually best reflects the effects of treatment in everyday practice. Per protocol analysis excludes patients who deviated from the protocol. It can introduce a form of bias called attrition bias, in which the groups of patients being compared no longer have similar characteristics.

What is the intention to treat ( ITT ) principle?

The Intention-To-Treat (ITT) principle. The intention-to-treat principle defines that every patient randomized to the clinical study should enter the primary analysis. Accordingly, patients who drop out prematurely, are non-compliant to the study treatment, or even take the wrong study treatment, are included in the primary analysis within

When to use the intention to treat analysis?

Intention-to-treat analysis is generally the primary analysis of a randomized controlled trial. It is of particular importance when patients have dropped outor crossed overfrom one treatment arm to another in done a therapy RCT. (Glaszious 2003)

What does deviation from protocol mean in intention to treat?

As in routine practice, not all patients in a clinical trial receive the treatment exactly as planned. In a trial, this is referred to as deviation from the protocol. In intention to treat analysis, the results from all patients assigned to a group are taken into account, including those who deviated from the protocol.