FOR IMMEDIATE RELEASE:

May 19, 2022

MEDIA CONTACT: 

e: jeanette.lenoir@mail.house.gov c: 202.480.5737

WASHINGTON, D.C. – Today, Congresswoman Yvette D. Clarke (D-NY) joined with Congresswoman Robin L. Kelly (D-IL) to introduce the bipartisan NIH Clinical Trial Diversity Act to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. This legislation builds upon the NIH’s current policies to enhance the inclusion of women, racially and ethnically diverse individuals and people across the lifespan in all NIH-funded trials. The NIH Clinical Trial Diversity Act is co-sponsored by Reps. Brian Fitzpatrick (R-PA), Tony Cárdenas (D-CA), and G.K. Butterfield (D-NC). The bill introduction comes one day in advance of Clinical Trials Day, a day marking what is believed to be the first randomized clinical trial, and which spreads awareness about the importance of clinical trials to medical and pharmaceutical discovery.

“Representation matters in every sector of our society, especially pertaining to pathology. When our nation’s clinical trials fail to adequately consider the unique needs of minority populations and different age groups and genders – in defiance of the data that clearly points to the need for clinical trial inclusions of diverse groups disproportionately affected by certain illnesses and diseases – it undermines every aspect of patient care and flagrantly fractures the bridge between science and medicine. Simply put, we have a crisis of underrepresentation in clinical trials that demands immediate action. For far too long, America’s most underserved people have been deficiently included in clinical trials vital to the discovery of new medicines and treatments. Consequently, breakthroughs in diagnostics, treatment and patient care rarely account for the specific health traits and needs of these diverse groups. And it indefensibly puts them at a heightened risk for adverse reactions. This bipartisan legislation, the NIH Clinical Trials Diversity Act, offers a clear pathway towards overcoming this alarming obstacle in our medical industry, and I am proud to support it,” said Congresswoman Clarke.

“The data are clear – underrepresented communities are disproportionately suffering and dying from certain illnesses and conditions. We’re not going to be able to address these disparities or help these communities unless we know how new drugs and therapies work in communities that are disproportionately impacted by disease. The way we learn more is by increasing clinical trial diversity,” said Congresswoman Kelly. “I am introducing the NIH Clinical Trial Diversity Act to ensure that all NIH-funded trials are moving medical science forward and including all Americans in our quest for treatments and cures. I am proud to be introducing this bipartisan legislation alongside my colleagues Reps. Fitzpatrick, Clarke, Cárdenas, and Butterfield.”

“Clinical trials that are representative of all demographics are vital to improving health equity and efficacy for all populations. It’s time for Congress to take action on this issue that is critical to public health and the well-being of populations that are disproportionately impacted by certain diseases and conditions,” said Congressman Fitzpatrick. “I am proud to support the bipartisan NIHClinical Trial Diversity Act, which will direct the NIH to work with clinical trial sponsors to develop and uphold measurable diversity goals and increase public awareness and participation in clinical trials, particularly in underrepresented communities.”

“Inclusive clinical trials don’t just make a difference for individuals and communities who have historically been excluded – they make the science better for all,” said Congressman Cárdenas. “When we fully consider a wide range of experiences and backgrounds, we make sure treatment options are as effective as possible for everyone. The NIH Clinical Trial Diversity Act is a key step forward as we work to promote health equity and transform the future of medicine.”

“I am proud to support the NIHClinical Trial Diversity Act, which will build on the National Institute of Health’s current policies to establish measurable goals across the lifespan in all NIH funded clinical trials. Science has made amazing progress in developing treatments and cures for conditions we long thought untreatable. But, to fully harness the potential of medicine and biopharmaceutical innovation we must ensure that research is inclusive of everyone. The NIH Clinical Trial Diversity Act will help ensure that all communities, including women and people of underrepresented races and ethnicities, are represented in science. By including diverse populations in clinical trials, we will be able to more effectively treat and cure disease, create healthier communities, eliminate disparities, and improve overall health outcomes for our country,” said Congressman G.K. Butterfield.

The NIH Clinical Trial Diversity Act will:

• Require NIH to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence as well as a rationale for specified goals and a recruitment plan;
• Ensure the availability of less burdensome follow-ups during clinical trials (e.g. fewer follow ups, phone participation, weekend hours) to increase participation of underrepresented populations;
• Launch a public awareness campaign across federal agencies related to research participation opportunities.

The NIHClinical Trial Diversity Act is endorsed by the American Cancer Society Action Network, American Psychological Association, Association of Black Cardiologists, Beyond Celiac, Doctors for America, FasterCures, Leukemia & Lymphoma Society, National Organization of Rare Diseases, Susan G. Komen Foundation, No Health without Mental Health, Society for Public Health Education (SOPHE), Touch, the Black Breast Cancer Alliance, and Verily.

“People from diverse racial and ethnic communities have been historically underrepresented in most clinical trials,” said Arthur C. Evans Jr., PhD, CEO of the American Psychological Association. “The Clinical Trials Diversity Act of 2022 would help ensure that the National Institutes of Health address the lack of diversity currently reflected in federally supported clinical trials. APA applauds Rep. Kelly’s efforts to advance health equity through ensuring diverse clinical trial research.”

“Despite efforts to improve diversity in clinical trials, Black patients continue to be woefully underrepresented, particularly in clinical studies for cardiovascular disease medicines. This lack of diversity contributed to racial bias in clinical decision making, and impacts decision making about the cost-benefit of therapeutics. Failure to achieve diversity in clinical trials has far reaching effects, including the perpetuation of disparities in health care. New approaches are needed to ensure increased participation of Blacks and other diverse racial and ethnic populations in clinical trials as participants and main principal investigators. The NIH Clinical Trial Diversity Act can potentially help to achieve the goal of improved clinical trial diversity. The Association of Black Cardiologists endorses this legislation and applauds Congresswoman Kelly for her leadership,” said Michelle A. Albert, M.D., MPH President, Association of Black Cardiologists.

“The data are clear that widespread racial health disparities in breast cancer outcomes continue to persist today. Breast cancer is the leading cause of cancer deaths among Black and Hispanic women in the U.S. and the second leading cause of cancer deaths for AANHPI women. Yet, clinical trial populations still fail to adequately represent these communities,” said Molly Guthrie, Sr. Director of Public Policy and Advocacy at Susan G. Komen. “Clinical trials must reflect the diversity of those affected by diseases like breast cancer, including these communities will ensure out research does not exacerbate health disparities and treatments are appropriately tested for any patient populations that will utilize a therapy. Susan G. Komen applauds Representatives Kelly, Butterfield, Cárdenas, Clarke and Fitzpatrick for their work to address this critical issue through the introduction of the NIHClinical Trial Diversity Act.”

“Ensuring clinical trials appropriately represent intended patient populations is a priority for NORD. Many different issues – including geographic, linguistic, cultural and socio-economic factors – exist that tend to reduce diversity in clinical trials, which can be especially challenging with rare diseases due to smaller clinical trials and a limited number of eligible patients. We applaud Rep. Kelly for introducing legislation to help expand clinical trial diversity in NIH sponsored clinical research,” said Heidi Ross, Acting Vice President, Policy and Regulatory Affairs, National Organization for Rare Disorders.

“For far too long, we have been prescribing treatments with uncertainty, unsure if our patients would experience the same benefits or risks seen in clinical trials as they often did not include participants like them. Efforts to encourage clinical trial sponsors to increase representation have failed to meaningfully do so and have only led to empty promises. Without enforceable measures, trials supported by our nation’s medical research agency will only continue to not reflect our nation’s population,” said Reshma Ramachandran, MD, MPP, Chair of the Doctors for America FDA Task Force.

“The findings of America’s research clinical trials will have much more meaning and impact if those trials have enrolled patients who reflect the entire public,” No Health without Mental Health.

“We need clear and actionable goals to achieve equitable participation in biomedical research and clinical trials,” according to Esther Krofah, Milken Institute Executive Director of FasterCures and Center for Public Health. “FasterCures applauds Rep. Kelly’s leadership in addressing accountability for NIH-funded researchers and clinical trial sponsors to ensure medical research and clinical trials represent historically marginalized groups.”

“The mortality rate of Black women with breast cancer is 41% higher than white women. This is unacceptable. Black women are largely excluded from trials that study breast cancer drugs and treatments. With low participation rates in clinical trials, Black women miss access to newly emerging and often life-extending treatments not otherwise available. Trial data, resulting treatment protocols, and product development don’t account for the many factors of Black breast cancer. We will not be able to change the devastating Black breast cancer mortality numbers unless we understand the physiology of Black women. We cannot do that until we have more Black women participating in clinical research. We firmly endorse Congresswoman Kelly’s NIH Clinical Trial Diversity Act. Frankly, it is a matter of life and death for Black women,” said Ricki Fairely, CEO of TOUCH, The Black Breast Cancer Alliance.

“The NIH Clinical Trial Diversity Act creates an opportunity for greater equity in clinical trials. As the leading partner in clinical trial recruitment for celiac disease, Beyond Celiac is committed to promoting diversity in clinical trials, to help ensure that patients from underserved communities are properly represented in all phases of clinical research and development of therapeutics for this disease. We applaud and thank Congresswoman Robin Kelly for her work in this space and support for the NIH Clinical Trial Diversity Act,” said Salvatore Alecsi, MD, PHD, Beyond Celiac Chief Scientist and Strategy Officer.

“Removing barriers to clinical trial enrollment that will increase participation among traditionally underrepresented communities is critical to our efforts to reduce the cancer burden,” said Lisa A. Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN). “The NIH Clinical Trial Diversity Act would help ensure that sponsors are building in plans to recruit representative participants and it shines a light on financial barriers that can keep patients from choosing to take part in a trial. ACS CAN is pleased to support this legislation.”

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