The University of California San Francisco (UCSF) recently announced its collaboration with the nonprofit Lazarex Cancer Foundation to initiate a 3-year study that will address barriers and find solutions to disparities in cancer clinical trials, particularly in regard to disparities related to participation of low-income populations and racial/ethnic minorities.
The study, titled Improving Patient Access to Cancer Clinical Trials (iMPACT), is currently being conducted at the institutional level and will focus primarily on strategies aimed at increasing trial enrollment among underserved patient populations. Strategies include identifying and mitigating notable financial barriers to enrollment, including costs associated with traveling to sites as well as lodging. In the initial study, a total of 250 patients across UCSF Health and University of Southern California will be enrolled. iMPACT investigators then plan to roll out the trial to other sites across the country.
Disparities & Access
According to Hala Borno, MD, Assistant Clinical Professor in the Division of Hematology/Oncology at UCSF and principal investigator of the iMPACT study, disparities in clinical trial recruitment have been a long-recognized issue in cancer research. While the NIH mandated the inclusion of women and minorities in publicly funded trials under the Revitalization Act in 1993, multifactorial contributors to current recruitment disparities still posit challenges for research recruitment across the globe.
“Differential access to care at research institutions offering cancer clinical trials leads to subsequent disparities in whom these trials serve,” Borno explained. “Moreover, linguistic and health literacy barriers contribute to these observed disparities. Additionally, the role of indirect added costs associated with clinical trial participation, such as travel and lodging, may be a major factor influencing enrollment trends.”
Complexities involved in clinical trial recruitment may extend beyond social factors, Borno added, suggesting that exclusionary eligibility criteria may be primary contributors to recruitment barriers for certain communities.
“For example, criteria such as degree of neutropenia may lead to disparities observed by race/ethnicity as we know that benign ethnic neutropenia, a condition where a low neutrophil count is observed on blood tests, is more commonly observed among patients of African descent,” she said. “Therefore, more stringent neutrophil cutoffs may lead to subsequent enrollment disparities by race/ethnicity in cancer clinical trials.”
“In the era of precision medicine, we are able to develop individualized treatment plans for patients based on the unique characteristics of their cancer biology,” Borno stated. “As an extension of this new era in medicine, it is more important today, than ever, to ensure that the patients who will ultimately be affected by the diseases we treat are represented in our clinical trials.”
She added that, if researchers fail to accrue diverse populations adequately in clinical trials, then the therapies that are developed may only be safe and effective for a subset of patients. As a result, researchers and clinicians may begin to observe a widening in the treatment gap. A lack of diversity in clinical trials, Borno said, may also result in missing important signals of efficacy or toxicity among different patient subsets.
In regard to what steps researchers can take to overcome these disparities in cancer clinical trials, Borno suggested that trials should have a collaborative and multi-leveled design.
“We know that there is no one-size-fits-all approach to tackle this problem given the complexity of contributing factors,” she noted. “One important step to overcome this barrier is to ensure that research institutions and sponsors make diversity among enrollees a high priority. This means investing in the infrastructure to examine the major drivers of disparities at any given site.”
Additionally, Borno explained that clinical trial sponsors should work to address “low-hanging fruit” that contribute to enrollment disparities. These may include ensuring adequate reimbursement for indirect participation costs.
The Lazarex Cancer Foundation has developed a model that is being tested in the context of the iMPACT study. The iMPACT study is assessing efficacy of a financial reimbursement program for patients who are participating in therapeutic cancer trials. Costs associated with travel, lodging, and airfare (for both patients and a caregiver) are addressed with the program in an effort to minimize the financial burden involved with participation in a clinical trial.
“The underlying hypothesis of this study is that such programs can help ensure improved access to clinical trials among financially vulnerable patients,” Borno explained. “By extension, these programs may improve diversity in clinical trials as well as enrollment and retention in therapeutic trials.”
Dana Dornsife, Founder of the Lazarex Cancer Foundation, said the program will focus on patients with all types of cancer in phase I, phase II, and phase III clinical trials. “We're giving every single patient who is interested an opportunity to participate in a trial, as well as the financial reimbursement program based on a sliding scale that's determined by their household income,” Dornsife explained. “The number one reason patients cite for not participating in the trial, aside from not knowing about it, is the out-of-pocket expenses. We're trying to eliminate that as a barrier.”
The second component of iMPACT, she said, is to provide consistent and culturally appropriate community outreach and engagement within minority communities. To accomplish this, iMPACT investigators head into targeted communities and within areas that have relationships with and serve minority patients with cancer. Doing so, investigators can educate these targeted patients about clinical trials and their role in cancer care.
“We want to also engage with these patients at the beginning of the cancer care spectrum, instead of coming in at the very end with clinical trials,” Dornsife commented. “We want to start at the beginning and go through prevention, help them understand the relevance of familial cancer history, and educate on early cancer detection to improve the mortality gap that exists between people of color and white people.”
Cultural and language barriers as well as faith-based barriers and socioeconomic challenges represent the most potent barriers for underserved populations to enroll in clinical trials. The role of iMPACT is to overcome these barriers, particularly as they relate to the financial impact participation has on patients, to include more diversity in cancer research.
“Increasing the participation of minorities in clinical trials has the value of understanding novel therapies for all spectrums of the population,” Dornsife added. “Right now, with the little minority participation we have, we don't know how some drugs work for these populations. We need equal opportunity drug development, so to speak, across the spectrum of our population.”
Eventually, Dornsife hopes iMPACT can be brought to the community level. “Instead of bringing the patients to the trials,” she said, “we want to try and bring the trials to the patient.” Some trials are too complex for this, but others may be able to accommodate patients without interfering with their day-to-day life. “Right now, our focus is still on getting launched at comprehensive cancer centers, see what impact we have, and then look beyond,” she concluded.
Brandon May is a contributing writer.
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