Health

FDA takes steps to improve diversity in clinical trials


This guidance also further demonstrates how we support the Cancer Administration’s Targeted Cancer goal to address inequities in cancer care, helping to ensure that every community in the United States have access to cutting-edge cancer diagnosis, treatment, and clinical trials. ”

Racial and ethnic minorities are underrepresented in biomedical research. Clinical trials provide an important evidence base for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the populations that will ultimately use the treatment.

It is well known that biological differences exist in how people respond to certain therapies. For example, variations in the genetic coding may make a treatment more toxic to a different racial or ethnic group. These variations can also make medications like antidepressants and blood pressure medications less effective for certain groups.

Diversity plans to improve enrollment of participants from underrepresented racial and ethnic subgroups in clinical trials“recommend that sponsors of health products develop and submit a Racial and Ethnic Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidelines.”

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Barriers to participation by racial and ethnic groups may include mistrust of the clinical research system due to past abuse, aspects of trial design such as recruitment efforts Inadequate use and maintenance, frequency of visits, time and resource constraints on participants, transportation, and participation in conflicts with caregivers or family responsibilities.

In addition, language and cultural differences, health literacy, religion, limited access in the health care system, and lack of awareness and knowledge about clinical trials are What and what it means to participate may affect clinical trial participation among racial and ethnic minority populations.

FDA remains committed to improving the inclusion of diverse populations in medical product and drug development and will continue to engage with federal partners, medical product manufacturers, healthcare professionals, and other health care professionals. health and health advocates to achieve this important goal.

To support FDA’s efforts to promote diverse participation, the Office of Minority Health and Health Equality created “Diversity in Clinical Trials Initiative“includes an ongoing public education and outreach campaign to help address some of the barriers that prevent diverse groups from participating in clinical trials.

Barriers to participation are addressed through a variety of culturally and linguistically adjusted strategies, tools and resources such as educational materials in multiple languages, dedicated websites with announcements and videos on public service, social media outreach, and ongoing stakeholder engagement, collaboration, and partnership

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In February, the Biden Administration revived the Cancer Moonshot initiative to further expand cancer prevention, detection, research, and care efforts throughout the federal government.

The FDA Commissioner is a member of the White House Cancer Cabinet, which is made up of agencies and departments organized to develop a unified strategy in the fight against the disease.

One of Cancer Moonshot’s goals is to address inequalities in access to cancer screening, diagnosis, and treatment across races, genders, regions, and resources. FDA Guidelines for Increasing Diversity in Clinical Trials Consistent with Cancer Prevention goals.

The draft guidance, developed by Project Equity of the Oncology Center, aims to ensure that data submitted to FDA for approval of oncology medical products fully reflects demographic representation. of participants for whom the medical product is intended to be used.

As this guidance applies to all medical products, the Center for Drug Evaluation and Research, the Center for Biological Evaluation and Research, and the Center for Devices and Radiological Health have also contributed to the this collaborative effort.

Source: Medindia



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