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With Industry’s Help, Lawmakers Seek To Diversify Clinical Drug Trials

By Colleen Becker  |  January 26, 2023

In the fight against cancer, at least 83 new drugs have been launched in the U.S. over the past five years, including treatments for breast cancer, prostate cancer and multiple myeloma. Without clinical trials, these medicines might not be available to patients today.

Clinical trials are essential to increasing access to new drugs. With the help of patient volunteers, clinical trials help health care providers evaluate the safety and efficacy of new cancer treatments.

Patients who participate in clinical trials are able to access new treatments not yet widely available and receive regular medical care from experts and researchers. They can also play a more active role in their health care while also helping others.

Despite this, less than 5% of adult cancer treatment is provided in a clinical trial setting. And trial participants often are white, cisgendered (having a sense of personal identity and gender that corresponds to their sex at birth) and middle-aged. Because people from other populations are often underrepresented, gaps in knowledge can result.

Participation barriers for patients from underrepresented backgrounds might include access and cost.

Access: Though patients may want to take part, they might be receiving treatment at an institution without an appropriate clinical trial—if one is available at all. In addition, restrictive eligibility criteria could exclude certain patient populations.

Cost: When patients take part in a research study, associated treatment costs are often covered by the trial’s sponsor, product manufacturer or health insurance. However, some patients may have insufficient coverage or none at all. Other medical costs related to the trial, such as those for lab tests or imaging, also might not be covered. Furthermore, patients may have difficulty affording transportation or lodging, getting time off from work or finding child care.

Besides patient costs, finding a stable funding stream to support infrastructure for clinical trials can be difficult. In addition to biotechnology and pharmaceutical companies, the National Institutes of Health often sponsors clinical trials. However, the number of NIH-supported trials has decreased over time. One study showed this could be partially attributed to a flat budget for the agency, although Congress has increased its appropriations since 2017.

Engagement: Research shows that communities of color historically mistrust medical institutions and providers. A recent example—hesitancy by communities of color to get the COVID-19 vaccine—demonstrates the importance of addressing mistrust. Other studies show that LGBTQ individuals have long faced challenges in accessing and utilizing health care. Additionally, patients, as well as their health care providers, may have limited awareness of clinical trial opportunities. Practicing culturally appropriate patient engagement, including having clinicians and staff who represent the recruiting community, may help build trust and improve enrollment.

State, Federal and Industry Efforts

To address these barriers, state and federal lawmakers, as well as industry organizations, have pursued a variety of actions.

State Actions

Several states—including Illinois, Massachusetts, Pennsylvania, Texas and Wisconsin—enacted laws to allow both public and private entities to reimburse medical costs and other expenses patients may incur while participating in a clinical trial.

California established the California Cancer Clinical Trials Program to increase cancer clinical trial access among women, patients from racial and ethnic minority communities, and socioeconomically disadvantaged communities. The program is funded through both public allocations and private donations. In addition to paying certain patient costs, the program will support education and community outreach, patient navigator services, counseling and well-being services, and research on the effectiveness of these measures to increase diversity in clinical trials

Federal Actions

The Henrietta Lacks Enhancing Cancer Research Act, signed into law in 2019, requires the federal government to study and report on the barriers to participation for underrepresented populations in federally funded cancer clinical trials.

For three decades, the Food and Drug Administration has encouraged the inclusion of underrepresented populations through regulation and guidance. In April, the agency released draft guidance to help clinical trial sponsors improve enrollment from underrepresented racial and ethnic populations.

Industry Organizational Efforts

A 2021 report by the Pharmaceutical Research and Manufacturers of America highlights five strategies to support more robust engagement and improve clinical trial diversity:

  1. Create a network of clinical trial sites in underserved communities.
  2. Develop a diverse pool of investigators and staff.
  3. Establish long-term relationships with and invest in communities.
  4. Engage communities in conversations.
  5. Provide sustainable support and standardized data platforms.

In addition, the organization released four principles on the conduct of clinical trials and communication of trial results:

  1. Building trust and acknowledging past wrongs.
  2. Reducing barriers to clinical trial access.
  3. Using real-world data to enhance information on underrepresented populations beyond product approval.
  4. Enhancing information about diversity and inclusion in clinical trial participation.

The Road Ahead

Developing partnerships to collect and share data might aid researchers in measuring and evaluating progress. These collaborations can also help identify best practices for states to consider. As developments in cancer therapies evolve, diversity in clinical trials will be a key component in shaping the treatment landscape.

Colleen Becker is a project manager in NCSL’s Health Program.

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