The persistent lack of diversity in clinical trials has come to the fore as one of the most salient challenges to trial success. Now we are seeing research, policy and industry commitment combine to build unprecedented momentum for impactful change. Many organizations have shared thought leadership to highlight the imperative for diverse trials; however, few have implemented processes and strategies that lead to more inclusive studies.
Recent legislation (Consolidated Appropriations Act, 2023) and the Federal Drug Administration (FDA) issued draft guidance (April 2022) outlining the need for the development of race and ethnicity diversity plans for products under the FDA’s remit, recommending that all products include a diversity plan. This guidance is a result of 30 years of policy priority and heroic efforts by healthcare advocates to improve clinical trial diversity, by enabling a more accurate understanding and demonstration of:
- Efficacy, via earlier identification during product development of racial, ethnic, socio-economic and other factors that can affect the effectiveness or ineffectiveness of a medical product.
- Safety, via earlier identification of safety issues that can then be addressed prior to launch.
- Indication-specific patient populations, via a better understanding of differences in care patterns for diverse patient populations (e.g., impediments to care, adherence issues) – insights that can be used to optimize launch and marketing strategy. As the importance of diversity in clinical trials is realized, Syneos Health is closing long-standing communications gap between patients and those who innovate on their behalf, focusing on engagement to reveal new insights into what’s critically important to patients in terms of research, experience and support, with initiative such as:
- Regulatory recommendations and support for the best regulatory pathways through clinical development plans and commercialization
- Operationalized teams with experience in supporting patient localization and access to clinical trials and registries, creating tailored strategies for each patient
- Partnerships with niche vendors who support tailored disease strategy logistics and ensure the patient remains at the center of everything we do
- Medical expert teams to provide input on partnering with drug developers to ensure strong development plans
- Effective commercial teams deployed early in the development process through commercialization to optimize prioritization strategy, pricing and reimbursement, public policy and engagement with patient advocacy groups and other stakeholders.
There is no single “point solution” to achieve appropriate diversity in clinical studies. We must address lack of patient diversity at every point in the cycle: education, study design, sites and engagement, patients. FDA guidance states what is needed. We must adapt, adopt, engage, and reinforce at all levels to make this work.