Studies have shown that approx. 70% clinical studies fail to meet enrollment targets, 25% of clinical trials are stopped because they fail to recruit enough patients.
Patient Recruitment is a key challenge in clinical studies, this is further compounded by the lack of diversity in clinical trials.
Approx. 39% of the US population are minorities however less than 7 % minorities participate in clinical trials. For instance, in the United States, African Americans make up 13.4% of the population, but only 5% of clinical trial participants. The disparity is even worse for the Hispanic or Latino population; they make up 18.1% of the U.S. population and only 1% of trial participants. Asian Americans account for 6% of the population and only 1% in clinical trials, and two-thirds of clinical trials are absent any Native American participation.
The lack of diversity is not limited to U.S. trials, however. A recent study of trials across 29 countries over the past 21 years shows that 86% of trial participants were Caucasian.
Diversity in clinical trials benefits everyone. Trials that over-represent Caucasians lack sufficient data on potentially relevant patient differences. This is extremely important, because in some cases, medicines affect people differently based on the age, race, sex or other factors. In addition regulatory agencies such as the FDA recommend an adequate representation of the population.
In the US, there are many historic reasons for the lack of clinical trial diversity such as the lack of trust because of some famed trials on minorities such as the Tuskegee Syphilis, Radioactive Iodine trials and many others.
Other reasons are lack of:
- Access to healthcare
- Logistics and Transportation
- Childcare
- Awareness
How we do this:
We employ Technology,Community relationships,Site preparation and Clinical trial awareness
- Working with the Clinical Trial Sponsor (Biotech/ Pharmaceutical Company or the Clinical Research Organization (CRO) we
- Review Protocol for Optimization
- Pre-identify patients leveraging technology e,g. EHR and other data sources
- Assist with site review and assessment
- Review and Develop Relevant Patient and Site Education Materials
- Provide preparation and education to sites in minority communities
- Leverage Relationships in Minority Communities and Patient Groups
We leverage existing relationships and work with
- Minority led clinical sites
- Access database of over 500 sites in minority communities
- Patient Advocacy and Community groups
- Leverage Digital Media and Social Media Outreach to Target Minority participants
- Develop virtual patient waiting rooms to o increase clinical trial awareness and pre-screen potential new clinical trial participants
- Develop social media outreach strategy to identify and direct potential patients for pre-screening
- Arrange logistics and transportation with partners to
- Arrange air, rail or ground transportation
- Hotel or long-term accommodations
- Visas for out of country travel
- Other concierge or personal needs
