The Food and Drug Administration (FDA) Diversity Action Plan requirement for all Phase 3 clinical trials or pivotal studies of new drugs makes it clear that appropriate participation of underserved populations is not simply a “nice to have” but a “must have” that brings immediate benefits to all key stakeholders. With proof of safety and efficacy across age, sex, and race, physicians have greater confidence in recommending novel treatments, so sponsors see increased uptake across all communities, and in turn, more patients experience life-changing and life-saving results. An added benefit? Over the long term, it engenders a self-sustaining cycle of sorely-needed trust-building among all three groups.
The challenge for healthcare innovators is that the inclusion of representative proportions of minority communities in trials has traditionally been seen as complex and time-consuming.
That’s where Inside Edge comes in. Our Clinical Trial Recruitment suite of services focuses exclusively on Black, Hispanic/Latino, Native American, and Asian populations — and increasingly, on specific subsets within these groups, like LGBTQ+ individuals. Our over-arching approach built around the on-the-ground relationships of our Trustmaker Network — specifically, our Community Influencer Cooperative and Independent Pharmacy Partnership — enables us to reduce existing barriers to trust and increase community interest, with an ease and speed that makes real diversity of representation possible for all clients and trials.
In collaboration with the client or the client’s CRO, Inside Edge team members and Trustmakers assist across the full span of the clinical trial process — from paper to field. Every step of the way we tailor our approach to consider the everyday realities of minority patients, finding ways to overcome misperceptions about clinical trials and challenges to protocol compliance.
Overcoming clinical trial disparaties
The vast gap in minority representation in clinical trials means that pharma and biotech companies are unable to identify and capitalize on significant health and business opportunities.
Our wide range of trial support capabilities ensures we can assist clients in not just preparing plans that meet the FDA’s new diversity protocols, but also putting in place the processes and people to execute with ease — and, ultimately, deliver on goals.
- Diversity Plan consultation
- DEI communications strategy and implementation
- Site evaluation and selection
- Protocol review and recommendations
- Materials evaluation and development
- Pharma staff and clinical training
- Community education and engagement
- Community pharmacy program
- Clinical site tactical support
- Ongoing enrollment and retention support