Advancing Diversity and Access to Cancer Clinical Trials

Today’s cancer treatments and the life-saving progress that has been made would not have been possible without thousands of people taking part in past clinical trials. And continued scientific advances in cancer treatment still rely heavily on people getting involved so that clinical trials can be successfully completed.

From the 1990s through the early 2000s, only about 2%-3% of adult patients with cancer took part in clinical trials. That number has increased to about 7% in more recent years. That’s mostly because of efforts to expand knowledge about and access to clinical trials. Some examples of this include:

• National Institutes of Health Revitalization Act of 1993, which required the inclusion of women and underrepresented racial and ethnic groups in federally funded clinical research
• Creation of clinicaltrials.gov to promote awareness of ongoing clinical trials
• New FDA guidance centered on loosening inclusion requirements and increasing diversity in clinical trials
• Medicare and Medicaid coverage for the extra costs of clinical trial participation 

What Are the Barriers to Taking Part in Cancer Clinical Trials?

Studies have shown that when people are asked if they would be willing to participate in a clinical trial, a whopping 55% say they would. Finding and managing roadblocks to clinical trials in the health care system is critical to moving science forward and saving lives.

One of the biggest hurdles to people taking part in clinical trials is that both patients and their doctors don’t know about them. When dealing with a potentially life-threatening diagnosis, most patients wouldn’t think to ask their doctor about a clinical trial.

In addition, most people with cancer get their care from hospitals that aren’t focused on academics or research. These community-based facilities don’t have the staff or processes to efficiently screen patients to see if they’re eligible for clinical research. And since these providers are focused on patient care, they often don’t know about available trials or have the time or expertise to answer a patient’s questions.

Other key barriers include:

Structural and logistical issues. Trial sites are too far away and/or patients don’t have time to take part.

Socioeconomic challenges. People can’t afford the out-of-pocket costs of clinical trials or are under- or uninsured.

Clinical issues. Overly strict rules limit patients who have other health conditions and older patients, even though they make up most patients with cancer. 

Cultural beliefs and language barriers

Mistrust of the health care system after past abuses in medical research. Studies like the Tuskegee Untreated Syphilis Study have resulted in years of distrust among some marginalized groups. (During the 40-year Tuskegee study, researchers did not get informed consent from the 600 Black men in the study. They did not treat the men with the standard care for syphilis. An advisory council eventually declared the study “ethically unjustified.”)

Why Diversity in Clinical Trials Matters

While the number of patients with cancer who take part in clinical trials is generally very low, the number of patients from racial and ethnic groups and very young and older populations is even lower.

Lack of diversity among people in clinical trials can lead to trial results that can’t be applied to all the people affected by the disease. Different groups can have different genetic profiles that affect how they respond to treatments. Genetic makeup, diet, lifestyle, and people’s surroundings can also affect how a drug is absorbed and broken down in the body. That can lead to differences in how well the treatment works and whether it has bad effects.

If clinical trials don’t use diverse groups of people, it could lead to less effective treatments for those who are not represented in the trials.

Solutions for Advancing Clinical Trial Participation

Given the critical importance of clinical trials in advancing new and more effective treatments for cancer, what can be done to increase access to and participation in clinical trials and increase diversity? Current ideas include:

Patient advocate involvement. Patient advocates are becoming more involved in planning clinical trials, which can make them more appealing to people who might want to be involved. Patient advocates often give input on the standards and help researchers look for features of the proposed trial design that might be barriers to patients (such as a lot of required visits, lab tests, and procedures that might not be necessary). Advocates can also help give out information about available trials to the communities they serve and be a resource for people who are thinking about being in a trial. 

Loosening strict rules about who can be in a trial. While proper eligibility rules are necessary to make sure patients stay safe, overly strict requirements can unnecessarily limit enrollment. The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research have led the creation of guidance documents aimed at updating clinical trial eligibility requirements that have been adopted by the National Cancer Institute for its sponsored trials. The FDA also has released guidance for trial sponsors with the aim of loosening eligibility requirements.

Offering financial support. One study suggested that it costs patients about $600 a month – travel, lodging, food, parking, and other expenses – to be in a clinical trial. Efforts to pay patients back for trial expenses are meant to remove this as a barrier. In addition, the FDA said that paying back patients is not considered undue influence and is generally acceptable.

Bringing trials to patients. To lessen the travel difficulties for people taking part in trials, large cancer clinical trial sites are teaming up with hospitals that serve more geographically and socioeconomically diverse communities. The FDA has also sent out guidance further promoting having clinical trials in multiple locations to reduce the burden on both patients and trial sponsors and to get and keep more people from diverse backgrounds in the trials.

By addressing barriers and coming up with ways to increase diversity in clinical trial participation, we can ensure that new cancer treatments are safe, effective, and meaningful to all groups. The progress we make today in cancer research will pave the way for more personalized and equal treatment options for people in the future. Everyone deserves the best possible care, and advancing diversity and participation in clinical trials is crucial to achieving that goal.