Study aimed at increasing diversity among clinical trial participants
USC Norris Comprehensive Cancer Center has launched a study to determine how financial assistance for costs associated with clinical trial participation might increase enrollment, particularly among low-income patients and racial and ethnic minorities. The study, known as Improving Patient Access to Cancer Clinical Trials (IMPACT), assesses social and cultural barriers to clinical trial participation.
Through IMPACT, all patients who qualify for a clinical trial at USC Norris are offered the opportunity to apply for a reimbursement program for out-of-pocket expenses associated with clinical trial participation, including travel and lodging. This includes patients seen at Los Angeles County + USC Medical Center, the USC Norris Treatment Center in Newport Beach, and anyone referred to USC Norris by affiliates and partners. Reimbursement is based on a sliding scale up to seven times the U.S. federal poverty guidelines, and information will be available in multiple languages to encourage diversity in clinical trial participation.
Fewer than 5% of adult cancer patients participate in clinical trials nationally, with ethnic and racial minorities enrolling at even lower rates. Economic concerns play a role in the lower participation, as low-income patients may lack adequate financial resources to pay for travel, childcare and time away from work.
The discovery of potentially life-prolonging therapies may be delayed and patients may miss out on promising treatments as a result of chronic under-enrollment. Low diversity in clinical trials also creates a lack of data on the nuances of personalized cancer treatment within underrepresented groups.
“USC Norris is situated in an area of rich diversity, thus our physicians and researchers are uniquely positioned to gather vital statistics in populations that might otherwise go uncovered,” said Darcy Spicer, MD, associate professor of clinical medicine at the Keck School of Medicine of USC and principal investigator of IMPACT. Spicer is also chief of medical oncology at USC Norris. “We are hopeful that this study provides more people with access to burgeoning clinical innovations, while informing the scientific community about the most effective means to treat cancer.”
IMPACT is a collaboration with the Lazarex Cancer Foundation, the only nonprofit in the U.S. that assists both adult and pediatric patients with finding clinical trials and reimburses them for the out-of-pocket travel costs of participating. Lazarex was founded on the principle that everyone — regardless of age, gender, race or financial status — should have access to cutting-edge treatments available through clinical trials.
Since 2007, Lazarex has invested more than $14 million in program services and helped more than 4,000 patients, including several at USC Norris. In 2018, at the urging of the foundation, the U.S. Food and Drug Administration issued new guidance allowing pharmaceutical companies to reimburse patients for travel costs to get to clinical trials, although not all trial sponsors do this.
“The potential benefits of clinical trials should not be the limited privilege of those with the knowledge, time and resources to navigate their complexities,” said Dana Dornsife, founder and board chair of Lazarex Cancer Foundation. She is also the namesake of the USC Dana and David Dornsife College of Letters, Arts and Sciences. “With more than 1.5 million people receiving a cancer diagnosis each year, it is imperative that we develop a model that hastens the speed of innovation while ensuring broad access to care.”
— Mary Dacuma