Diversity in Patient Engagement
SSLS is committed to increasing the enrollment of participants in underrepresented communities, underserved populations which historically have been ignored, by educating the importance of healthcare, the benefits of clinical trials and how they have evolved, as well as addressing any concerns that may keep members of marginalized communities from participating in such clinical trials and communicating the legacy of healing and health.
WHY IS THIS IMPORTANT?
Clinical trials over the past several decades have provided immeasurable value in helping to determine the efficacy, toxicity, and the tolerance levels of a plethora of medical products including drugs and medical devices. The public has a general understanding that the clinical trial process is needed to objectively approve new medical products, while life science industry members utilize guidelines released by the US Food & Drug Administration (FDA) to help design regulated processes from manufacturing through to clinical trials. It has become clear to the FDA and the pharmaceutical industry that under-representation of minorities in clinical trials is detrimental to successful clinical trials, especially due to a lack of key data from under-represented minority patients
WHY IS THIS IMPORTANT?
Clinical trials over the past several decades have provided immeasurable value in helping to determine the efficacy, toxicity, and the tolerance levels of a plethora of medical products including drugs and medical devices. The public has a general understanding that the clinical trial process is needed to objectively approve new medical products, while life science industry members utilize guidelines released by the US Food & Drug Administration (FDA) to help design regulated processes from manufacturing through to clinical trials. It has become clear to the FDA and the pharmaceutical industry that under-representation of minorities in clinical trials is detrimental to successful clinical trials, especially due to a lack of key data from under-represented minority patients
THE TIME IS NOW
In April 2022, the FDA released ‘Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance.’ All entities submitting FDA documentation need to demonstrate that their proposed clinical trials incorporate sufficiently diverse racial and ethnic patient participants to provide the best possible and clearest results for drug and diagnostic products (2). In November 2020, the FDA provided ‘Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance’, which adds to previous FDA minority inclusion guidance (3). According to this new guidance (2), the “FDA recommends that a Plan to enroll representative numbers of participants from historically under-represented racial and ethnic populations be submitted to the investigational new drug (IND) application, for a drug, including biological products regulated as drugs, or the investigational device exemption (IDE) application for a device.”
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THE TIME IS NOW
In April 2022, the FDA released ‘Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance.’ All entities submitting FDA documentation need to demonstrate that their proposed clinical trials incorporate sufficiently diverse racial and ethnic patient participants to provide the best possible and clearest results for drug and diagnostic products (2). In November 2020, the FDA provided ‘Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance’, which adds to previous FDA minority inclusion guidance (3). According to this new guidance (2), the “FDA recommends that a Plan to enroll representative numbers of participants from historically under-represented racial and ethnic populations be submitted to the investigational new drug (IND) application, for a drug, including biological products regulated as drugs, or the investigational device exemption (IDE) application for a device.”
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