Many clinical trials continue to face challenges in recruiting participants who accurately represent the populations affected by the disease under study. These challenges are often made more complex by a lack of clear transparent communication, undefined roles and responsibilities, and limited shared accountability among partner groups.  

Without a coordinated and strategic approach across the trial lifecycle, efforts to improve enrollment remain fragmented and inconsistent. These gaps often result in trials that do not represent the disease population under study, limit the generalizability of findings, and reduce confidence in the data supporting medical product approval and use. 

CTTI’s project aims to address these concerns by gathering evidence and developing strategies to clarify expectations, strengthen communication, and support coordinated action across partner groups. This work will result in practical tools and recommendations to help design and conduct clinical trials that foster participant representation aligned with disease epidemiology and scientific evidence. 

Collective Strategies to Enhance Proportionate Enrollment

As part of this work, CTTI plans to:

1. Define and outline activities, key implementation considerations, and pain points across clinical trials partner groups. 
2. Work to understand collaborative perspectives and address varying interpretations of enrollment strategies and expectations.
3. Gather and share practical tools and approaches to help overcome common barriers to proportionate enrollment.
   

By supporting a shared understanding of contributions, expectations, and roles across clinical trials partner groups, this project will promote coordinated action that improves the enrollment and retention of participants who reflect real-world populations. 

These efforts will help ensure that clinical trials produce high-quality data that better support the development of safe and effective medical products and allow for more meaningful analysis of safety and efficacy across all populations. 

CTTI will use qualitative research methods, including interviews with partners involved in planning, recruiting for, and implementing clinical trials. These partners represent a range of roles across contract research organizations, institutional support teams, patient groups, sites, and sponsor organizations.

Insights from these interviews will inform the development of recommendations and resources to guide clinical trials teams in designing and carrying out more representative trials. 

The Collective Strategies to Enhance Proportionate Enrollment project is expected to yield the following: 

• A set of recommendations or best practices outlining key implementation considerations, including common terminology, communications strategies, and clearly defined roles and responsibilities. 
• A reference guide that outlines the responsibilities and contributions of each clinical trials partner group throughout the trial process.
   

Organization affiliations are listed as active affiliations during the project.

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