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FDA issues new draft guidance to improve diversity in clinical trial design

By May 6, 2022May 18th, 2022No Comments

The US Food and Drug Administration (FDA) is recommending sponsors include a plan to enrol more participants from underrepresented racial and ethnic populations into clinical trials. 

Under the new guidance, published on April 13, clinical trial sponsors are required to submit a Race and Ethnicity Diversity Plan to the FDA whenever submitting an application for an Investigational New Drug (IND), Biologics Licence Application (BLA) or an investigational device exemption (IDE). Regulators will consider the plan “an important part” of the product’s development program. 

“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert M. Califf, M.D. 

“Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities. This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics and clinical trials.” 

The need for greater equality in clinical trials is both a scientific and ethical issue, with racial and ethnic minorities remaining underrepresented. Without full diversity, data cannot be considered complete and it’s impossible to say how a certain treatment will work for everyone, particularly those in minority groups. Read more about why diversity in clinical trials matters in our previous article on the topic here

As part of the guidance, the FDA acknowledges that some minority groups may be wary of taking part in clinical research, alluding to the African-American community and their mistrust in the trials process due to historical abuses. Other barriers to trial participation in minority groups include financial barriers and difficulty attending and completing the study, language and cultural differences, health literacy, religion and socioeconomic factors. 

How mdgroup is tackling diversity in clinical trials 

From the very beginning, we have worked closely with other organisations and put solutions into action to ensure that we are actively engaging diverse communities and raising awareness around our clinical trials.

To combat the barriers to entry, we already offer a number of solutions to increase accessibility for clinical trials, including covering expenses, providing travel stipends and reimbursements, and offering in-home visits via our mobilehealth nurses. All of our solutions put the patient at the heart of the process, to make their experience with us even more remarkable, whilst the sponsor benefits from higher [participation rates. 

We also can help map out key locations for increasing diversity, advising you which cities and regions you need to target. We’ll talk to you about your protocol and how we can support you to make changes to the protocol design to increase accessibility for diverse populations. 

Diversity in clinical trials is a critical step along the path to equality, and this guidance from the FDA goes some way to closing the gap with a practical solution to hold sponsors to account. 

We’re on a mission to deliver remarkable experiences for patients taking part in site-based and decentralised clinical trials around the world. We support pharma and biotech companies to attract, engage, and maintain patient participation in clinical trials, and provide end-to-end support for DCTs around the world, all underpinned by the latest innovations in healthcare technology. Let’s make your next study remarkable. Contact us now to discuss how.

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