Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors

Area of Science:

• Clinical Trials
• Biostatistics
• Research Methodology

Background:

• The intention-to-treat (ITT) principle mandates analyzing participants within their assigned groups.
• Handling randomisation errors is crucial for maintaining ITT principles but receives limited attention.
• This article addresses the implications of randomisation errors in clinical trials.

Purpose of the Study:

• To demonstrate the potential pitfalls of correcting randomisation errors.
• To provide guidance on managing common randomisation errors.
• To ensure adherence to the intention-to-treat principle when errors occur.

Main Methods:

• Illustrating pitfalls through examples of randomisation error correction.
• Providing guidance on handling specific randomisation errors.
• Utilizing documented experiences for practical recommendations.

Main Results:

• Correcting randomisation errors can compromise trial integrity.
• Documenting errors is more consistent with the intention-to-treat principle than correction.
• Specific guidance is provided for handling incorrect baseline data, ineligible participants, multiple randomisations, and incorrect treatment allocation.

Conclusions:

• Randomisation errors are common and should be reported in trial publications.
• The intention-to-treat principle offers a framework for responding to randomisation errors.
• Adopting a documentation-focused approach preserves the integrity of randomized controlled trials.