Navigating trial enrollment roadblocks for underrepresented populations

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/DutchScenery)
(Image: Getty/DutchScenery)

Related tags: trial recruitment, Oncology, Clinical trials, Clinical research, Clinical data, Clinical data management

Social, cultural, and financial barriers pose a challenge in enrollment for oncology clinical trials, but USC investigator believes mitigating barriers to diversify research may provide comprehensive data.

University of Southern California’s (USC) Norris Comprehensive Cancer Center launched a study to examine the role of financial assistance in diversifying clinical research.

The study, Improving Patient Access to Cancer Clinical Trials (IMPACT), assesses the barriers to clinical trial participation and poses queries regarding the diversity of Oncology trials. Questions like, how can diversity lead to better data?

“When you have therapies tailored to specific genetic mutations and treatment decisions based on how tumors are behaving at the molecular level, it stands to reason that different ethnicities may respond to cancer therapies in different ways. The treatment landscape is changing rapidly, and without diverse clinical trial enrollment we are losing valuable data that could widen disparities down the line,” ​Darcy Spicer, lead investigator of the IMPACT trial at USC Norris and chief of the division of Oncology at US Norris Comprehensive Cancer Center, told us.

He added that one of the biggest barriers to clinical trial enrollment, particularly in Oncology, is social or cultural barriers.

“Patients may not know how to find clinical trials or organize the logistics of participation. Others may feel wary of being part of something experimental,”​ Spicer explained.

USC is in a highly diverse area, and that is reflected in its patient population, said Spicer in regards as to how this study will present evidence of the implications of diversity.

“We have oncology clinic locations in demographic pockets throughout Los Angeles County, including Koreatown and Arcadia, which is a heavily populated Chinese community,”​ said Spicer. It is believed by USC that because of its location its physicians and researchers can gather statistics in populations that might otherwise go uncovered.

The USC study is open to anyone who qualifies and while it has not garnered a trend in improving data yet, the study’s pilot program conducted at Massachusetts General Hospital, found improvements in enrolling underrepresented minorities.

A three-year pilot IMPACT program at Massachusetts General saw an improved overall enrollment by 29% and doubled clinical trial participation in underrepresented minorities, Spicer explained.

How can diverse enrollment be achieved?  

Outside of social and cultural considerations that may prevent enrollment, out-of-pocket costs often create a roadblock to trials.

Dana Dornsife, founder of Lazarex Cancer Foundation, which is partnering on the IMPACT study, said in a statement, “The potential benefits of clinical trials should not be the limited privilege of those with the knowledge, time and resources to navigate their complexities.”

She added, “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."

Spicer told us that transportation costs can be significant when patients are required to visit the trial site regularly, or if the site is not local and requires lodging.

He added that costs can incur as childcare, lodging, or other incidentals come about, and patients may not have the financial means to pay for them.

“Out of pocket costs associated with clinical trial enrollment are often not reimbursed,”​ Spicer added.

Last year, Lazarex went to the US Food and Drug Administration (FDA) with concerns regarding out of pocket costs for patients in trials. After advocating to the agency, the FDA issued a guidance allowing pharmaceutical companies to reimburse patients for travel costs, however, it is not mandated, and Spicer said that not every clinical trial sponsor will reimburse.

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