Could master protocols be adapted for effectiveness-implementation hybrid studies?

Area of Science:

• Translational Science
• Implementation Science
• Clinical Trial Design

Background:

• Master protocols streamline multi-study clinical trials using a shared infrastructure.
• Translational research bridges scientific discovery and public health impact by assessing intervention efficacy and real-world effectiveness.
• The application of master protocols to effectiveness-implementation hybrid studies remains underexplored.

Purpose of the Study:

• To develop recommendations for adapting master protocol methodologies for effectiveness-implementation research.
• To explore how master protocols can support hybrid effectiveness-implementation sub-studies.
• To provide a framework for integrating implementation science within master protocol designs.

Main Methods:

• Consultation with translational research networks from January to December 2024.
• Analysis of requirements for service providers in translational research.
• Review of implementation frameworks to inform protocol adaptations.

Main Results:

• Recommendations cover common trial infrastructure, hypotheses, data collection, control groups, adaptive elements, and eligibility criteria.
• Leveraging cross-sectoral partnerships and co-produced research accelerates the translational pipeline.
• Adaptive elements within master protocols enhance the efficiency of effectiveness-implementation studies.

Conclusions:

• Adapting master protocols for hybrid studies can improve the implementation of evidence-based interventions in routine care.
• The feasibility of master protocols for effectiveness-implementation research requires further investigation.
• Testing the proposed methodology is essential for advancing implementation science within master protocols.