Because traditional randomized controlled trials do not typically occur in a real-world clinical care setting, the data produced may not reflect the performance of medical products in the populations that will use them. Or, conversely, the trials may become inefficient and expensive if they replicate activities that already occur in clinical care.

Integrating components of clinical trials intended for medical product review into clinical practice can remedy these issues. However, no evidence-based set of guidelines previously existed to help operationalize this integration. CTTI’s work in this area has created recommendations and resources to help clinical trial stakeholders embed trials into real-world clinical practice. 

Practical Approaches to Embedding Clinical Trials into Clinical Practice 

As part of this work, CTTI will:

• Identify when elements of interventional clinical trial integration into clinical practice would be feasible and the associated benefits and risks
• Identify the barriers and potential solutions to incorporating interventional trials into clinical practice.
• Describe the operational approaches to incorporating interventional trials into clinical practice.

The project team will engage in the following activities to support the project objectives:

• Interview sponsors, research sites, and stakeholders across health care settings on their approaches and the challenges to integrate interventional trials into clinical practice.
• Compile case studies of select randomized trials that describe operational approaches to incorporating interventional trials into clinical practice.
• Convene a multi-stakeholder meeting to discuss issues and strategies.

The Practical Approaches for Embedding Clinical Trials into Clinical Practice project is expected to yield the following:

• Best practice recommendations and manuscript
• Summary of interview results and manuscript
• Multi-stakeholder meeting summary
• Collection of case examples

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.