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Improving Cancer Therapy Research

Modifying How Clinical Trials Are Conducted

Decades ago, all cancer patients were treated with similar drugs. Scientists now understand that cancers which originate in various parts of the body are more affected by certain drugs than others. As we gained a better understanding about the biology of cancer, we developed new therapies that honed in on specific types of cancer. To bring such targeted therapies to patients, clinical trials are required. 

Clinical trials determine the safety and efficacy of all new drugs, surgical procedures, and therapeutic strategies. In the public health field, we rely on clinical trials to establish effective therapies to treat cancer. However, there is a substantial gap between certain patient populations and how cancer therapies are developed.

Our group at VCU Massey Cancer Center recently published a study in the Journal of Clinical Oncology – with collaborative efforts from colleagues at the University of Florida (UF) College of Medicine and UF Health Cancer Center – which determined that minority patient participation in cancer clinical trials is significantly low.

Specifically, we determined that traditional eligibility criteria – a set of standardized requirements that must be met for a patient to enroll in a clinical trial – disproportionately prevent Black patients from participating in pancreatic cancer clinical trials. Between 2010 and 2019, we found that 42 percent of Black patients were ineligible for pancreatic cancer clinical trials compared to 33 percent of white patients, even though pancreatic cancer is more likely to occur in Black patients.

The American Cancer Society estimates that more than 62,000 people were diagnosed with pancreatic cancer in 2022. African Americans are more likely to develop the disease.

As it stands, the standard of care in all cancer treatment is based on studies conducted primarily with non-Hispanic white patients. Changing the standard criteria for clinical trial enrollment could have a major effect on increasing eligibility in underserved populations, reducing disparities in trial participation, and creating results that are more reflective of the
patients we serve.

Why clinical trials should include more non-white patients

Diverse participation in clinical trials provides more equal access to investigational drugs, as well as informs a broader evaluation of how certain drugs will affect a wider range of patients. People from different racial and ethnic backgrounds have unique molecular (genetic) and biological compositions. Therefore, one patient’s resistance or response to a cancer treatment could be completely different from another patient’s based on their individual genes. Increased diversity in clinical trial participation can potentially help reduce disparities in cancer survivorship.

Unfortunately, Black, Asian or Pacific Islander, American Indian or Alaskan Native, and Hispanic patients have been historically underrepresented in pancreatic cancer clinical trials. While there are many known factors that contribute to this – including partial distrust in the health care system, systemic racism, lack of diversity among doctors, and inaccessible healthcare – research teams have largely ignored how eligibility criteria may also affect representation in clinical trials.

For instance, there are many medical conditions associated with underserved populations that can be medically controlled (to allow participation), but can exclude a patient from enrolling for a cancer clinical trial. These include HIV, hepatitis, chronic kidney disease, diabetes, obesity, and malnutrition. For example, the majority of people in the country who have co-morbidities associated with diabetes happen to be Black and minority patients, but diabetes can be well-controlled in a relatively short period of time for most patients. 

It’s our belief that many of these conditions should be removed from the eligibility criteria for pancreatic cancer clinical trials. Collaborating with medical specialists who can co-manage these conditions during a cancer clinical trial could allow more patients to be safely enrolled instead of being denied eligibility. 

As oncologists and clinicians, we should sit down with our patients and say: “We’re going to help you control your diabetes. We’re going to deal with your HIV. We’re going to deal with your other controllable conditions. Most importantly, we’re going to get you in this clinical trial because you deserve it, and we might be able to better address cancer health disparities in pancreatic cancer as well as many other cancers.” When we start acknowledging the role physicians play in clinical trial participation, we will start turning the tide toward a better patient experience and improved outcomes. It is when we truly understand our community that we will make a difference.

Although the research in our study examined pancreatic cancer clinical trials specifically, we believe our findings represent common barriers that are not specific to pancreatic cancer, and therefore apply to clinical trials for other types of cancer.

Effectively changing the standard by which eligibility criteria are developed and evaluated cannot be accomplished individually, but through a collective effort by medical providers, patient advocacy groups, professional societies, clinical trial funders, regulatory agencies, industry partners, researchers, and other stakeholders who have the power to influence real policy change.

Photography: Thomas Kojcsich

Jose Trevino, MD, surgeon-in-chief at VCU Massey Cancer Center, is the chair of the Division of Surgical Oncology at the VCU School of Medicine. In addition to caring for patients and teaching, he is a physician-scientist who investigates pancreatic cancer tumor biology, microenvironment, cancer-induced muscle wasting, and how it can all relate to pancreatic health equity in underserved and underrepresented communities.
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