Legislation to Advance Equality and Inclusion in Oncology Clinical Trials

According to the Association for Clinical Oncology, individuals who identify as African American or Black make up 13.4% of the US population and only 6% of individuals who participate in cancer-related clinical trials. The Hispanic or Latino population represents 18.1% of individuals in the US and only 2.6% of the population who participates in cancer-related clinical trials. To ensure the highest quality patient care, it is critical that investigators conducting clinical trials investigate and gather data on how new drugs and devices affect under-represented populations. The recently passed legislation described below aims to increase diversity in oncology clinical trials by reducing barriers to participation for under-represented populations.

There are a variety of reasons these populations continue to be under-represented in clinical trials, including geographical limitations, language barriers, socioeconomic disparities, and historic research abuses within a given community. These recent requirements seek to address and reduce such issues, though research staff also have an important role in building trust and confidence with potential participants.

The Clinical Treatment Act

While close to 20% of Americans – including children, pregnant women, and people with disabilities – receive their health insurance from state-administered Medicaid programs, only 15 states in the US require their programs to cover routine care costs for Medicaid recipients participating in clinical trials. However, all major insurance programs, including Medicare, cover these costs. Routine care costs include payment for physician visits, laboratory procedures, imaging (x-rays and scans), and other procedures that would be covered by insurance if the Medicaid recipient were not participating in a clinical trial. These costs do not include procedures performed solely for the purposes of the trial, which would ordinarily be reimbursed by the sponsor of the trial.

In December 2020, the Clinical Treatment Act (H.R. 913/S. 4742) was passed as part of the COVID-19 stimulus package, paving the way for improved access to clinical trials for more than 40 million Americans. The Clinical Treatment Act ensures all state Medicaid programs cover routine care costs for individuals participating in clinical trials for serious or life-threatening conditions, such as cancer. These costs would include the management of side effects experienced as a result of participating in the trial. Implementation of the new law will go into effect in January 2022.

Honoring Henrietta Lacks

The Henrietta Lacks Enhancing Cancer Research Act (H.R. 1966) was also passed in December 2020 and is yet another step toward decreasing health disparities and improving access to clinical trials for minorities. This legislation calls for the Government Accountability Office (GAO) to complete a study that reviews “how federal agencies address barriers to participation in federally-funded cancer clinical trials by individuals from underrepresented populations.” The ultimate goal of the study is to help the federal government strive for greater diversity in oncology clinical trials. The bill also requires the GAO to propose recommendations to address barriers identified.

Henrietta Lacks was a black woman who died from cervical cancer on October 4, 1951. As a woman of color, Lacks’ treatment for her diagnosis included the standard of care afforded to this population for invasive cervical cancer. Two samples were removed from her cervix without her knowledge or consent. Lacks’ cells have been utilized in medical research for decades without recompense to her family and have led to the development of medical breakthroughs to treat cancer, HIV/AIDS, and Parkinson’s Disease. Research findings from her cells also led to the development of the polio vaccine.

Closing the Gap

Passing the Clinical Treatment Act and the Henrietta Lacks Enhancing Cancer Research Act will help to improve diversity in oncology clinical trials and reduce disparities among participants. A large portion of individuals covered by state Medicaid insurance programs are from populations who are typically underrepresented in clinical research. Ensuring routine costs for participation in clinical trials and studying how the federal government can remove barriers to participation will also guarantee that individuals currently without access to new and innovative therapies receive it, thus reducing health disparities and expanding treatment options for those in need.

The Belmont Report

Created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published on April 18, 1979, The Belmont Report outlines three ethical principles guiding research review and conduct:

1. Respect for Persons – individuals are autonomous agents and additional protections should be provided for those with diminished autonomy
2. Beneficence – protecting individuals from harm and ensuring their well-being
3. Justice – asks who ought to receive the benefits of research and who bears its burdens

The Belmont Report states: “Whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.” The newly passed legislation aligns with the expectations outlined in the Belmont Report and is a tremendous advancement in ensuring diversity and equality in oncology clinical trials.

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