By Maxine Bookbinder

May 21, 2019 | The Lazarex Cancer Foundation is working to sustainably achieve minority equity and increased enrollment in cancer clinical trials nationwide by eliminating financial barriers, increasing community outreach, collaborating with comprehensive cancer centers, and attaining bipartisan Congressional action.

Through offering financial reimbursement for travel and companion expenses, Lazarex has doubled and tripled minority participation. "In 2012, we realized we could only support as many patients as we had dollars in the bank and we weren't solving the problem at its source," says Lazarex founder Dana Dornsife. "These problems include a lack of information about trials and the inability to pay travel costs to attend trials. Potentially life-saving drugs are free in trials, but those free drugs are worthless if the patient can't afford to participate."

In 2013, the non-profit launched a 3-year exploratory study with Massachusetts General Hospital, the Lazarex MGH Cancer Care Equity Program, offering travel reimbursement and ongoing community outreach to educate people about the benefits of clinical trials and accessing and enrolling them. "We wanted to remove barriers and help patients understand the clinical trial journey, what it is and what it involves," says Dornsife.

At the end of the Lazarex/MGH program, enrollment in its cancer clinical trials increased by 29% and minority enrollment almost doubled, from 6.5% to 12.8%. The national average of non-white clinical trial participants is 5%.

To formalize and expand this success, Lazarex rebranded the Cancer Care Equity Program in 2016 to IMPACT (Improving Patient Access to Cancer Clinical Trials), launching it with Amgen as the founding sponsor, in collaboration with the University of Southern California Norris Comprehensive Cancer Center and University of California, San Francisco Hellen Diller Family Comprehensive Cancer center. Lazarex is also now working with Abramson Cancer Center at the University of Pennsylvania. Dornsife says she was focused on "how to turn a noble program into a sustainable program and actually fix the problem. This is what is standing between cancer patients and life."

IMPACT's goal is to sustainably break the barriers to cancer clinical trials by focusing on local recruitment, improving trial diversity, increasing community place-based engagement, and offering expense reimbursements at time of consent for out-of-pocket travel costs for the patient and a companion.

Because poverty is disproportionate for some minority communities, says Dornsife, drug efficacy, side effects, and testing is vastly underrepresented in these populations. "We have to focus on improving minority participation to see how drugs impact all demographics, not just some. If 95% of participants are white, then we don't have an understanding of the full impact of drug."

IMPACT facilitators, or Community Program Leaders, are from the local communities and maintain a continual presence in hospitals, community clinics, centers, churches, and other social networks, asking doctors to educate patients about trials and talking with residents about trial benefits. "It must be someone in the community willing to bear the torch," says Dornsife. "Minority patients have higher mortality rates because they are diagnosed too late. We focus on early diagnosis, trial participation, consistency, and continuity. People are more comfortable talking to a community program leader they already know rather than a stranger."

Of the 97 patients currently enrolled in the IMPACT program, 74% are from minority communities; 77% of the reimbursed dollars are to households earning $25,000/year or less. "We are creating access for patients who would not be able to participate in these trials. The return on investment is clear. It's all about proving it," says Dornsife.

Reimbursement is seven times the government poverty line, awarded on a sliding scale based on household income, and continues for the entire trial duration. The average reimbursement to IMPACT patients is $171/month, most of which pays for local travel expenses, such as gas, parking, and bridge tolls. In contrast, since many Lazarex/MGH Cancer Care Equity Program participants travel longer distances between states, its average monthly reimbursement is $334/month.

The concept of reimbursement to socio-economically challenged cancer patients was initially complicated due to FDA guidance language regarding coercion and inducement, intended to prevent low-income patients from being taken advantage of. Lazarex took the issue to Congress and the FDA and in January 2018, the FDA issued new guidance saying that reimbursement is not considered coercion, inducement, or undue influence. With this change, the FDA accepted reimbursement as a platform to create equitable access.

State bills also passed in California and Pennsylvania, initiated by Lazarex, that recognize out-of-pocket expenses as a barrier to trial participation, identify what can be reimbursed, and encourage industry support. Dornsife says that "the new language is what allows us to have different conversation with pharma, which will ultimately eradicate this problem."

Dornsife launched Lazarex in 2006 after her brother-in-law was diagnosed with pancreatic cancer. To date, the 11-person company has helped 4,500 patients, 31% from minority populations, navigate clinical trial options or pay out-of-pocket and travel companion costs.

There is much more work to do, says Dornsife, who hopes to expand to comprehensive cancer centers nationally. She also would like to see out-of-pocket expenses included in every clinical trial budget; the return on investment would increase retention and enable completion. "We have the opportunity to literally transform the industry, make the problem go away, and create a platform of equitable access."