The U.S. Food and Drug Administration has issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials—expanding on the agency’s previous guidances for industry to improve clinical trial diversity.
Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research. Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment. It is known that biological differences exist in how people respond to certain therapies. For example, variations in genetic coding can make a treatment more or less toxic for one racial or ethnic group than another. These variations can also make drugs like antidepressants and blood-pressure medications less effective for certain groups.
指导草案Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials”建议，根据指南中概述的框架，医疗产品的赞助商在临床开发的早期就将种族和种族多样性计划制定并提交了一项种族和种族多样性计划。
种族和民族之间的壁垒参与groups may include mistrust of the clinical research system due to historical abuses, aspects of the trial design such as inadequate recruitment and retention efforts, frequency of study visits, time and resource constraints for participants, transportation and participation conflicting with caregiver or family responsibilities. In addition, language and cultural differences, health literacy, religion, limited access within the health care system and a lack of awareness and knowledge about what a clinical trial is and what it means to participate may impact clinical trial participation among racial and ethnic minority populations.
FDA仍致力于增加医疗产品和药物开发中不同人群的入学人数，并将继续与联邦合作伙伴，医疗产品制造商，医疗保健专业人员和健康倡导者互动，以实现这一重要目标。
To support the FDA’s efforts to advance diverse participation, the Office of Minority Health and Health Equity created the “Diversity in Clinical Trials Initiative,” which includes an ongoing public education and outreach campaign to help address some of the barriers preventing diverse groups from participating in clinical trials. Barriers to participation are addressed through a variety of culturally and linguistically tailored strategies, tools and resources such as: educational materials in multiple languages, a dedicated webpage with public service announcements and videos, social media outreach and ongoing stakeholder engagement, collaborations, and partnerships.
In February, the Biden Administration revived the Cancer Moonshot initiative to further expand cancer prevention, detection, research, and patient care efforts across the federal government. The FDA Commissioner serves as a member of the White House Cancer Cabinet, comprised of departmental agencies and components organized to develop a unified strategy in the fight against the disease. One of the goals of the Cancer Moonshot is to address inequities in access to cancer screening, diagnostics and treatment across race, gender, region, and resources. The FDA’s guidances on increasing diversity in clinical trials are aligned with the Cancer Moonshot goals.
指南草案是由肿瘤学中心的项目公平中心开发的，该公平旨在确保提交给FDA的数据充分批准肿瘤学医学产品，以充分反映了预期医疗产品的参与者的人口统计学。根据本指南适用于所有医疗产品，药物评估与研究中心，生物制剂评估与研究中心以及设备和放射健康中心也有助于这一合作努力。
