The United States Food and Drug Administration (FDA) have released their latest guidance for clinical trials, regarding the topic of enhancing the diversity of clinical trial populations; with the purpose for releasing this guidance being due to the FDA’s recognition of the need for a better representation of those who are most likely to use the medicinal product in question, once released to market, and to reflect this within the participants of the clinical trial.
To summarise their guidance document, the FDA has communicated their recommendations for the improved design and execution of clinical trials for participants with different demographic and non-demographic characteristics, ranging from age, ethnicity and gender, to disabilities, smoking status and other medical condition; in addition to outlining steps to help improve and broaden existing eligibility criteria within clinical trials, to increase diversity in enrolment, with key considerations made for inclusive trial practises, trial designs, methodological approaches and enrichment strategies. Additional recommendations made can also be seen for the topic of improving both study design and improving enrolment, aiming to make the trial process less burdensome for participants; revising both enrolment and retention processes, to promote inclusivity and expanding access.
With regards to how this update relates to COVID-19, the FDA has communicated that the significance of this guidance is increased by the current COVID-19 public health emergency, due to the virus affecting and impacting on different sections of the population in various ways, and on a global scale, highlighting the requirement for a diversified approach to the development of medicinal products moving forward; most notably for COVID-19 vaccination works, to help ensure that the best possible efficacy is achieved for the much broader population.
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PharSafer will continue to monitor guidance released by the FDA and communicate any new information as it becomes available.