We are approaching a golden age of scientific research, especially when it comes to fighting cancer. In recent years, we’ve seen a number of innovations that will help cancer patients: the advent of biomarkers allowing doctors to treat cancer with targeted therapy; approved cancer immunotherapies such as CAR T-cell therapy; and the acceleration of research innovations with CRISPR gene-editing technology .These breakthroughs are fast changing the treatment options available to people with cancer.
Even more promising is that doctors are pairing their improved knowledge of cancer screening tests with advances in earlier effective treatments, an approach known as “Cancer Interception.” Cumulatively, these advances will likely keep our momentum moving forward, increasing the chances of survival for patients.
{mosads}Momentum begets momentum, of course. But these advances aren’t possible without funding, the development of ambitious clinical trials, and most importantly, pools of diverse patients to participate in the trials.
Thankfully, we have no shortage of ambition or creativity in our scientists. Earlier this year, the latest federal budget included an increase of $275 million for the National Cancer Institute (NCI). That budget increase, combined with the 21st Century Cures Act authorizing $1.8 billion to fund the Cancer Moonshot program, and seed investment to establish the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to modernize the cancer drug approval process, will make an impact on overall cancer mortality and survival outcomes.
But we need more than funding and researchers to attack cancer. We need patients to participate in clinical trials, particularly patients who are not Caucasian. Despite ongoing national media attention to the issue, the FDA’s Drug Trials Snapshots program shows that blacks or African-Americans made up only 2 percent, Hispanics 4 percent and Asians 9 percent, of participants in clinical trials for new cancer therapeutics in 2017, a vast underrepresentation compared to the statistics about who gets cancer.
Since the 1970s, we have known that black Americans face higher rates of cancer death compared to their white American counterparts. Almost a half-century later, this black and white health divide persists. According to the most recent American Cancer Society data, non-Hispanic black males have the highest overall cancer incidence and death rates compared to other racial/ethnic groups. Black females have 14 percent higher cancer death rates than non-Hispanic white females despite 7 percent lower incidence rates. A recent series of studies by the Centers for Disease Control and Prevention (CDC) shows survival rates for colon cancer, breast cancer, and ovarian cancer in the U.S. are all lower for black people than for white people.
Analyses of black or African-American participation in cancer clinical trials provide clues into the systemic roots of these health disparities. In 2015, a novel drug was approved to treat advanced breast cancer (known as ER+/HER-) based upon clinical trial data that had only two African-American women, about 1 percent of the total participants.
Yet national cancer data report that more than 60 percent of breast cancer cases among non-Hispanic blacks are ER+/HER-, while non-Hispanic blacks make-up less than 9 percent of ER+/HER- cases in the United States. In 2016, the pivotal clinical trials used to approve a novel drug for prostate cancer involved 68 black or African-American patients (6 percent) compared to 800 white participants (66 percent), despite a 74 percent higher risk of prostate cancer among blacks.
In comparison, cancer disparities for Hispanics are different but also compelling, for example diagnosis at later stages of the disease. According to the American Cancer Society, the US Hispanic population is vulnerable to cancer inequalities due to disproportionate poverty and other barriers to health care. Hispanics have among the highest prevalence of important cancer risk factors for cancer such as obesity and diabetes, as well as other behavioral and environmental exposures that may contribute to cancer risk. Disparities cannot be generalized from one ethnic population to another.
Because clinical trials are the most important and reliable means available to provide scientific evidence and effective care management for cancer patients, it is imperative to ensure all Americans have the opportunity to participate in clinical trials. If we are to make any progress in closing the gap, we must innovate and redesign the clinical research enterprise to account for those largely unaccounted for.
Addressing why black or African-American participation in oncology trials remains low, despite their disproportionate burden of disease, requires new perspectives integrating multidisciplinary domains with the traditional clinical research sciences.
New approaches are needed across clinical trials, starting from the design of trials with provisions to engage and enable participation, to the assessment of barriers to participation such as: financial hardships; inclusion/exclusion criteria impacting eligibility to participate; and logistical barriers that limit access to trials. Systematic change is needed to erase the unconscious racial biases that may impact who’s given an opportunity to participate. Grants for medical research and clinical trials should be expected to demonstrate how they will be innovative in their communications and recruitment strategies.
While no one denies the complex challenges in addressing multifaceted health disparities, continuing to operate under the same clinical research paradigms but expecting a different result will continue to deprive large numbers of Americans from receiving the most effective cancer treatments. A more thoughtful approach to trial design will help make care more cost-effective and reduce the suffering of people with cancer and their families in every neighborhood in America.
Sung Poblete, Ph.D., R.N., is the CEO of Stand Up To Cancer. John Whyte is the chief medical officer at WebMD and most recently the Director of Professional Affairs and Stakeholder Engagement at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.