Conducting a Time Trade-Off Study Alongside a Clinical Trial: A Case Study and Recommendations

Area of Science:

• Health Economics
• Clinical Trial Methodology
• Quality of Life Research

Background:

• Time trade-off (TTO) is an established method for eliciting health-state utilities in health economics.
• Health-state utilities are crucial for measuring health-related quality of life and calculating quality-adjusted life-years.
• TTO is particularly valuable when generic instruments may not fully capture utility changes in clinical trials.

Purpose of the Study:

• To provide practical guidance on designing and conducting Time trade-off (TTO) studies alongside clinical trials.
• To address the limited existing guidance for integrating TTO into clinical trial research.
• To serve as a practical guide and reference for future applications of the TTO method in clinical settings.

Main Methods:

• A case study approach detailing the design and development of a TTO study within a clinical trial.
• Description of material development for TTO interviews.
• Inclusion of piloting of TTO materials and the interview process, with recommendations for future studies.

Main Results:

• Successful development and piloting of TTO study materials and interview processes within a clinical trial context.
• Identification of practical considerations and challenges in conducting TTO alongside clinical trials.
• Formulation of recommendations to enhance the design and execution of future TTO studies in clinical trials.

Conclusions:

• The Time trade-off (TTO) method is a valuable tool for assessing health-state utilities in clinical trials.
• Conducting TTO studies alongside clinical trials requires careful planning and methodological considerations.
• This paper provides essential practical guidance for researchers aiming to implement TTO in clinical trial settings.