Diversity and inclusivity are needed in clinical trials for medical products to “confront healthcare disparities”, according to FDA commissioner Dr Stephen Hahn.

In a statement, the commissioner said researchers and medical product sponsors alike must make sure clinical trials are more inclusive of multiple populations – by accounting for logistical factors and other participant-related issues that can limit trial participation.

He referred to an FDA guidance document entitled Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs, which was issued on 9 November, and details how inclusion of “important groups”, such as women, racial and ethnic minorities, children and older adults, should be considered.

Hahn also highlighted the importance of clinical trial participants representing the populations that are most likely to use the medical product being tested.

“We have seen these healthcare disparities, for example, during our fight against Covid-19,” he added.

“Certain segments of the population including older adults, pregnant women, children, and racial and ethnic minorities are affected in different ways.

“This difference in impact illustrates why we must encourage developers of any medical product – such as treatments or vaccines for Covid-19 – as well as medical products more broadly, to endeavor to include diverse populations to understand their risks or benefits across all groups.”


Importance of clinical trial diversity and inclusivity

Hahn claimed that designing and executing clinical trials should be done with consideration for different demographic characteristics like sex, race, ethnicity, age and location of residency, and non-demographic characteristics, including patients with organ dysfunction, comorbid conditions and disabilities, and people at weight range extremes.

An example he gave to help improve inclusivity was decreasing visit frequency for trial participants, and using flexible visit windows or electronic communications like phones, emails and other digital health technologies to reduce the burden on those taking part.

Hahn also recommended broadening clinical trial eligibility criteria to improve enrollment and retention of participants – and noted that sponsors should consider early engagement with patient advocacy groups and patients to elicit suggestions for designing trials that participants would be willing to enroll in, or support.

He concluded the statement by reaffirming that “clinical trials, and the people who volunteer to participate in them, are essential to help develop safe and effective medical products to fight diseases and illnesses”, and said the FDA will continue to engage with groups from across the medical industry to achieve enrollment of more diverse populations in trials.