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Racial diversity is not the only category we need to improve. We must also diversify clinical trials with people across age groups and by sex and ethnicity. Last year, in an analysis of more than 20,000 trials over the past 20 years, the NIH found that sex bias persists within clinical trials, with male and female participants underrepresented in different areas of research. It’s essential that we follow the data to ensure that our clinical trials adequately represent everyone who may be impacted by a treatment or disease.
Moreover, participants in research on public health issues do not always reflect the people most impacted by the issue. For example, even though men are 3.7 times more likely to die by suicide than women, the male median percentage rate of participation in research studies on suicide prevention was only 29%.
These low rates of representative participant samples are concerning because people may react differently to certain interventions, drugs and products based on their race, ethnicity, age or sex. That is why I have introduced the NIH Clinical Trial Diversity Act. We cannot rectify America’s health inequities without studying the treatments within the populations that would actually use the drugs.
This bipartisan legislation builds on NIH policies to enhance the inclusion of women, racially and ethnically diverse individuals and people across the lifespan in all NIH-funded trials. The bill requires the agency to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence. It also calls for improved recruitment plans; less burdensome follow-ups to make it easier for people to complete participation; and a public awareness campaign across federal agencies related to research participation opportunities.
Private industry and health advocates are supportive of increasing clinical trial diversity. In developing the NIH Clinical Trial Diversity Act, I worked with and received endorsements for the bill from a broad group of nationally and internationally respected healthcare organizations.
Both healthcare advocates and private industry representatives recognize the value in expanding clinical trials to improve diagnoses and treatment options. Undeniably, we know America has a health equity problem. Increasing clinical trial diversity is a good start to help us solve that problem.
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