Vision

For a large pharma company, its growing desire to better serve underrepresented populations and build trust and confidence in drug efficacy in clinically relevant patients remained unfulfilled.

New FDA guidance sparked a renewed vigor to get ahead of industry trends and regulators and drive Diversity & Inclusion (D&I) in its clinical trials. The company felt ready to shift from just talking about D&I to taking action and making a difference. 

Challenge

The scale and scope of Clinical Trials and Research & Development operations called for comprehensive D&I guidance, tools, and techniques. The company needed to address cross-functional D&I considerations and challenges throughout the development lifecycle.

As a trusted partner with experience in developing effective clinical operations playbooks, the company reached out to Genioo to help produce a high-quality, robust D&I playbook at speed. 

Approach

Our collaboration with the clinical operations lead, D&I champion, and key stakeholders across Research & Development deepened our understanding of clinical trial population issues — eligibility criteria, exclusions, contraindications, and underrepresentation. 

We mapped these considerations and challenges across study design, methodology, protocols, recruitment, participation, and reporting. And we embedded the tools and techniques to target a trial population mix reflective of the patients likely to take the drug if approved. We further outlined a stringent process to broaden trial eligibility criteria in line with clinical trial phases and drug safety protocols.

Impact 

The company now has a clear and consistent approach to improving D&I in its clinical trials. It can use this guidance to embed D&I knowledge and understanding into the culture of its teams and the fabric of its clinical and business operations.  

Armed with the right knowledge and motivation, clinical teams can proactively drive D&I in clinical trials and champion health equity. And in doing so, they will strengthen reputation and relationships among employees, industry, regulators, and society, and more importantly, build public trust.