Patient Diversity Case Study: RWD Solutions

Situation:

A large pharmaceutical company was looking to further diversify clinical trial participants for its NASH study. The sponsor was behind in recruitment of Hispanic and Asian patients and wanted to understand the ratio of these populations at each of its selected sites.

Solution:

Leveraging medical claims and diversity data, a site-level analysis was conducted to identify relevant patients meeting the trial’s I/E criteria, broken out by race and gender.

Validation of Selected Sites:

• Examined sponsor-selected sites to confirm clinically relevant patient populations matching the trial’s l/E criteria, by volume.

Assessment of Site-Level Patient Diversity by Desired Demographics

• Further analyzed selected sites to uncover pools of targeted patient level demographics (race and gender) to meet diversification goals.

Matched Sites and Investigators by Clinical Trial Experience

• Assessed the site/investigator’s historical trial experience in relevant indications and prioritized those sites with a more prolific trial portfolio aligned with sponsor’s needs.

Delivery of Reprioritized Site List Based on Analytic Findings

• A reprioritized site list was provided to the sponsor highlighting key institutions with a diverse, clinically relevant patient population to drive recruitment goals