# How person-centered trial design improves clinical research

## Executive summary

Some of the **most frequently reported reasons** for recruitment failures in clinical research include eligibility criteria that are too narrow and a high level of participant burden. These shortcomings, as well as others we discuss in our report, “Faster results, better outcomes: How person-centered trial design improves clinical research,” characterize study designs that lack person-centricity, leading to:

**Missing large segments of the population**, such as women, people of color, individuals with a lower socioeconomic status, and people in rural areas

**Failing to reach a representative sample** of the specific population being studied

**Inadequately capturing the everyday experiences** that affect individuals’ health outcomes

**Medical products and interventions that are not successful commercially** because they do not provide the benefits important to people or address people’s unmet needs

**Ultimately, operational, regulatory, and commercial challenges** due to longer study timelines, an inability to show the product has value, and a lack of acceptance by end users

As the foundation for decisions around health care, **clinical** **research is perfectly positioned to lead the person-centricity** **movement** spreading across the healthcare industry. Using the participant voice to inform study design can help **ensure the final** **product delivers value to the end users** and bridges the gap between the outcomes important to clinicians and researchers and those that truly matter to the individuals who will be using the product in real life.

Despite **evidence** that participant input has a direct impact on the entire research lifecycle, from study design to commercialization, the inability to efficiently collect that information often serves as a barrier for companies to actualize the full benefits. Supported by real-life case studies and example questions to ask of individuals and their families, the five strategies presented in the report can serve as a starting point for research teams to design studies that truly view participants as people.

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## Five strategies to design studies that work for, not against, people

| STRATEGY | CONTEXT | BENEFITS |
| --- | --- | --- |
| 1. Identify the inclusion and exclusion criteria that more closely reflect the characteristics of the intended population | Characterizing the intended study population through diverse characteristics and preferences is key to establishing realistic, representative, and efficient inclusion and exclusion criteria. | Faster recruitment and enrollment 
More accurate benefit-risk profile
More efficient endpoint analysis
Segmented analyses |
| 2. Prioritize person-centric outcomes in clinical trials | Combining what participants want with the specific research goals can achieve the study's aims while addressing unmet needs resulting in better participant outcomes and greater satisfaction with treatments. | Improved retention
Relevant outcomes
Better reimbursement potential
Increased adoption |
| 3. Design low-burden assessments for better adherence | Making it easier to meet the study requirements makes it more likely that individuals will agree to participate and be able to complete all the required assessments. | Faster recruitment and enrollment
Improved retention and compliance
Higher-quality data |
| 4. Incorporate intuitive study materials and tailored support for enhanced engagement | Communicating in ways that participants understand shows respect, ensures they understand what is expected, and increases engagement with study materials. | Participants clearly understand:  
What is being asked of them  
What they can expect in return  
How their information is being used |
| 5. Recruit people where they are, both geographically and regarding their readiness to participate | Early participant feedback and involving organizations and community leaders they trust can ease recruitment, improve communication, and overcome negative perceptions about research. | Faster recruitment and enrollment  
Greater number of positive screens for timely enrollment  
An inclusive, representative study population |