Jul 5, 2022
Dr. Jennifer Jones-McMeans is a Divisional Vice President of Global Clinical Affairs at Abbott Vascular Business and she sheds light on the FDA guidance to encourage sponsors of clinical trials to include all genders, ethnicities, and under-represented patients to participate. New guidelines are more organized and provide better guidance for what sponsors of clinical trials should consider during their submissions to the FDA.
Jennifer explains, "If you think about where clinical trials sit, clinical trials are part of the overall healthcare ecosystem. And if we consider that the healthcare ecosystem is to be inclusive, it is to make sure that there are appropriate treatments for women and different ethnic groups. Also understanding that possibly there could be differences in maybe therapeutic responses, or even considering access too. Clinical trials have to then move forward as the medical ecosystem is moving forward to ensure that there's treatment available for all patients. And so this is where again, this guidance is just a guideline to help support that pathway for clinical trials."
"We do know that there are specific populations that, based on their access to health and lack of trust that can occur with the healthcare system, when it comes to clinical trials, they may actually not know and have an awareness of the clinical trial. But they also may not be connected with the appropriate medical system or within a medical system to even have that access. So that's some of the work that we know that the sponsors can do in reaching out."
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