TITAN

Tool objective

Target trial emulation is a method of designing observational analyses so that they explicitly emulate a hypothetical randomized trial (i.e. the target trial) that would answer the question at hand; it can be considered as an attempt to make causal inference with observational data.

The aim of this tool is to provide guidance for emulating a target trial assessing a pharmacological intervention, in order to avoid major errors and biases by design.

The tool aims to provide guidance to emulate a target trial that is:

• a pragmatic randomized controlled trial ;
• comparing two interventions (two-arm trial);
• assessing a pharmacological intervention; and
• assessing the initiation and/or adherence to an intervention.

The main characteristics of a pragmatic trial are:

• having less stringent eligibility criteria (broader population);
• having flexible intervention and comparator as it would be in clinical practice and
• measuring outcomes that are directly relevant to participants, funders, communities, and healthcare practitioners.

Sections

The tool is organized in three sections:

1. Definition of the target trial
2. Design of emulation using observational data
3. Additional information

A series of statistical methods are proposed, however they are non-exhaustive, and the consultation of a statistician during the process of the target trial emulation is necessary.

A synthesis will be generated that includes a table illustrating the design elements and definitions of the target trial, modified target trial and the emulation, in addition to a summary of possible biases and proposed solutions.

Notes:

• "Additional information": opens in a separate window, when clicked.
• "More info": provides details in a box on the same page, when clicked.
• Underlined dotted words: provide details in a pop-up, when hovering over it.

We're constantly working to improve the tool.

Please don't hesitate to contact us if you notice any issues or have suggestions (titan@clinicalepidemio.fr)