FDA is reducing health disparities in clinical trials and research for chronic and debilitating diseases.
FDA is working to eliminate health disparities in clinical trials, research, and treatments of chronic, debilitating diseases.
The agency needs to increase equity across the care continuum, stated a recent blog post authored by Captain Richardae Araojo, PharmD, MS, Associate Commissioner for Minority Health, Office of Minority Health and Health Equity; Ann T. Farrell, MD, Director of the Division of Hematology Products within the Center for Drug Evaluation and Research; and Jovonni Spinner, MPH, CHES, Senior Public Health Advisor, Office of Minority Health and Health Equity.
“The disparities in health span everything from cancer and diabetes to heart disease, sickle cell disease, and HIV/AIDS. The FDA’s work on these issues is a priority—and is intrinsic to the work we do across the agency,” the authors said.
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“The FDA, including the Office of Minority Health and Health Equity (OMHHE), promotes and protects the health of diverse populations and strives for health equity for all, including those who experience disparities related to race and ethnicity.”
The agency is working to reduce disparities and encourage diversity in clinical trials. Racial and ethnic minorities continue to be underrepresented in clinical trials and disproportionately affected by debilitating diseases. These populations may lack transportation, time, or knowledge about clinical research opportunities, contributing to lower rates of representation.
“The FDA’s primary role in clinical trials involves reviewing clinical research as part of the regulatory process. As an agency, the expectation is for medical product research to ensure ethical and legal protections for patients and to reflect the relevant science,” the authors wrote.
“To this point, FDA regulations require developers who submit applications for medical products to analyze clinical trial data by sex, age, and race. And the FDA continues to regularly work with stakeholders—including federal partners, medical product manufacturers, medical professionals, and health advocates—to encourage diversity and inclusion in clinical trials.”
The agency has also issued guidance on the collection of race and ethnicity data in clinical trials. The document stated that clinical trials should use standard terminology for race, sex, gender, and ethnicity to ensure that subpopulation data is collected efficiently. The agency recommended that clinical trials submit data in a standardized, uniform format as well.
In addition to the issued guidance, FDA has created a Minorities in Clinical Trials Initiative that includes patient videos and additional resources planned for the coming year. The agency is continuing to work with patients to increase their understanding of the benefits of clinical research and the importance of knowing the facts when making decisions about clinical care.
FDA is also aiming to eliminate disparities in areas of disease and treatment. The agency has made considerable strides in improving health equity for patients with sickle cell disease, a genetic disorder that affects the body’s red blood cells.
“Sickle cell disease, also a public health priority for HHS, is most common among African Americans. But other racial and ethnic groups also are affected, including Latinos and people of Middle Eastern, Indian, Asian, and Mediterranean backgrounds,” the authors said.
“The Administration has committed to supporting research to develop a cure for the disease and has noted that clinical trials to accelerate the development of new gene and cell-based therapies will be conducted as part of the National Institutes of Health’s Cure Sickle Cell Initiative.”
In 2017, FDA approved two new treatments for sickle cell disease: one for adults and children age five or older and another for children age two or older. The agency is also discussing next steps, new treatments, and new ways to communicate known information to further improve therapies for sickle cell disease.
“For instance, the FDA’s Center for Drug Evaluation and Research (CDER), not only reviewed and approved the two new treatments but is actively encouraging companies to develop additional therapies. Today, a growing number of new, potential therapies are now in the pipeline, with products now in early- and late-stage clinical trials,” the authors said.
FDA can now grant expedited and priority review to therapies intended to treat sickle cell disease via a “fast track” or “breakthrough therapy” designation. These designations allow companies to have early and more frequent interactions with the agency.
Additionally, in October 2018, FDA led a joint public workshop with the American Society of Hematology to discuss clinical trial endpoints for sickle cell disease. The workshop aimed to provide uniformity and standards to existing disease endpoints, identify gaps, and propose development of new endpoints as a focus for future research.
FDA Offices and Centers are now trying to find the best ways to distribute this information so that patients, stakeholders, and government partners can continue to participate in these efforts. The agency has also planned additional meetings focused on endpoint development for later this year.
Going forward, FDA will continue its efforts to reduce health disparities in clinical research and treatment.
“Differences in health outcomes continue to exist, but as we spotlight them and work to develop timely and forward-looking solutions, including more diverse representation in clinical trials as well as timely and impactful communications with our various audiences and partners, the FDA is doing its part to both recognize and reduce them,” the authors concluded.
“Today and every day, the FDA pledges to continue this important work with stakeholders, other local and federal agencies, and patients across the country.”
Date: May 28, 2019
Source: Health IT Analytics