For decades, the pharmaceutical industry has struggled to recruit and retain diverse participants for clinical trials. More recently, this failure is resulting in new regulatory and legal risks and costlier trials.
On April 14, the FDA released new draft guidance advising sponsors to develop and submit racial and ethnic clinical trial recruitment plans. Although the FDA's guidance is currently non-binding, sponsors are closely assessing their response.
The FDA cannot mandate minimum thresholds for representation without Congressional action, but the agency can (and does) withhold approval of certain drugs until adequate enrollment is achieved. Additionally, the FDA could grant contingent approval and then require additional trials for full regulatory approval. In either scenario, failure to recruit and retain diverse participants will result in increased costs and slow the speed of medications reaching patients.
The industry must accelerate its efforts to recruit and retain diverse patients, despite historic mistrust, limited trial awareness, trial design – from eligibility to site selection, and other structural barriers that have made participation particularly challenging.
While the industry has broadly accepted the need to diversify trials, they have struggled to operationalize equity within their get-to-market-quickly strategy. Clinical studies are often limited to one trial or one disease indication and a limited number of sites, rather than a holistic approach which requires an ability to engage diverse communities across the country at scale. In engaging with local communities to increase enrollment, Ichor has heard from potential participants that they face several hurdles to join and stay in trials: (1) late discovery of disease renders them unable to participate; (2) lack of financial resources and/or adequate transportation and proximity to trial sites renders it unduly burdensome to continue participation; and (3) work and family obligations limit availability.
A data-driven “bottom-up” strategy is required to build trust and transformational partnerships in communities that have historically been at the fringes of clinical trials. Specifically, pharmaceutical companies need to connect on a local level in key cities, gather data on the specific pain points that are pervasive in each community, and then tackle those in a targeted way. For example, creating pop-up trial sites making them more available to participants, and ensuring internal teams include experienced community health workers who can bring a community perspective to strategy development. Similarly, developing local or city-wide community advisory boards where the unique perspective of health such as improving housing and eradicating food deserts are considered in the engagement process. These are important steps and help create wins for underserved communities and the broader clinical trial industry.
At Ichor Strategies, we have facilitated these relationships locally and at scale nationally, across a wide range of industries. Our on-the-ground presence in 70 cities across the country, deep relationships in diverse communities, and unparalleled research capabilities allow us to help accelerate the diversification of clinical trials by solving for the barriers that have limited previous trial participation. To learn more about how we can support the development of culturally competent recruitment and retention strategies, contact us here.
On April 14, the FDA released new draft guidance advising sponsors to develop and submit racial and ethnic clinical trial recruitment plans. Although the FDA's guidance is currently non-binding, sponsors are closely assessing their response.
The FDA cannot mandate minimum thresholds for representation without Congressional action, but the agency can (and does) withhold approval of certain drugs until adequate enrollment is achieved. Additionally, the FDA could grant contingent approval and then require additional trials for full regulatory approval. In either scenario, failure to recruit and retain diverse participants will result in increased costs and slow the speed of medications reaching patients.
The industry must accelerate its efforts to recruit and retain diverse patients, despite historic mistrust, limited trial awareness, trial design – from eligibility to site selection, and other structural barriers that have made participation particularly challenging.
While the industry has broadly accepted the need to diversify trials, they have struggled to operationalize equity within their get-to-market-quickly strategy. Clinical studies are often limited to one trial or one disease indication and a limited number of sites, rather than a holistic approach which requires an ability to engage diverse communities across the country at scale. In engaging with local communities to increase enrollment, Ichor has heard from potential participants that they face several hurdles to join and stay in trials: (1) late discovery of disease renders them unable to participate; (2) lack of financial resources and/or adequate transportation and proximity to trial sites renders it unduly burdensome to continue participation; and (3) work and family obligations limit availability.
A data-driven “bottom-up” strategy is required to build trust and transformational partnerships in communities that have historically been at the fringes of clinical trials. Specifically, pharmaceutical companies need to connect on a local level in key cities, gather data on the specific pain points that are pervasive in each community, and then tackle those in a targeted way. For example, creating pop-up trial sites making them more available to participants, and ensuring internal teams include experienced community health workers who can bring a community perspective to strategy development. Similarly, developing local or city-wide community advisory boards where the unique perspective of health such as improving housing and eradicating food deserts are considered in the engagement process. These are important steps and help create wins for underserved communities and the broader clinical trial industry.
At Ichor Strategies, we have facilitated these relationships locally and at scale nationally, across a wide range of industries. Our on-the-ground presence in 70 cities across the country, deep relationships in diverse communities, and unparalleled research capabilities allow us to help accelerate the diversification of clinical trials by solving for the barriers that have limited previous trial participation. To learn more about how we can support the development of culturally competent recruitment and retention strategies, contact us here.
