Implementing less rigid, more flexible operational approaches to clinical trials can enhance patient and site access to research, improve participant satisfaction, facilitate the use of real-world data, and enroll more diverse patient populations, leading to more generalizable trial results and ideally faster delivery of new therapies. However, there are questions around how to maintain data quality when offering flexible approaches, such as embedding trials in clinical practice and incorporating decentralized elements. Quality trial data must be fit-for-purpose, credible, and reliable to support regulatory decision-making without errors that impact participant safety or result credibility.

CTTI's project aims to address these concerns by gathering insights from partners and developing strategies to ensure data quality while leveraging the advantages of flexible trial designs.

Optimizing Data Quality in Trials that Incorporate Flexibility

As part of this work, CTTI will:

1. Identify the range of flexible operational approaches; their advantages, disadvantages, implementation practicality; and how the approaches might affect data quality. 
2. Seek consensus around critical concerns for data quality, including acceptable ranges and best practices to ensure data meet their intended purpose. 
3. Describe considerations for maintaining data quality when using flexible operational approaches in interventional clinical trials. 

By addressing concerns about data quality and providing clarity around when, if and how to integrate flexible approaches, CTTI’s work aims to enhance patient and site access to research, improve participant satisfaction, and facilitate the use of real-world data, ultimately bringing therapies to patients faster. 

Evidence to support CTTI’s findings will be gathered through a comprehensive approach that includes multi-partner round tables to collect diverse perspectives on flexible operational approaches, examining their advantages, disadvantages, and impact on data quality. CTTI will also conduct in-depth interviews or surveys to assess the practicality of these approaches.  The insights generated by these strategies may inform a variety of recommendations and resources to help regulators, sponsors, sites, and data/tech integrate flexible methods into their clinical trials while maintaining data quality. 

The Trial Flexibilities project is expected to yield the following:

• Case examples of flexible approaches in trials  
• Summary of multi-partner responses to case examples 
• Toolbox of flexible approaches– outlines strengths of flexible trials and potential recommendations of how to maintain data quality while incorporating flexible approaches 

Organization affiliations are listed as active affiliations during the project.

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