By Maxine Bookbinder

April 15, 2020 | A non-profit foundation is spearheading legislation that give thousands of underserved and hopeful cancer patients access to clinical trials and potential life-saving drugs. The Clinical Trial Participation Act reiterates FDA guidance that reimbursing patients for out-of-pocket travel expenses associated with cancer clinical trials is not considered coercion or inducement.

The Lazarex Cancer Foundation initiated discussions with FDA that led to the Agency’s January 2018 guidance to no longer equate reimbursement with inducement for cancer patients. However, FDA guidance does not establish any rights for any person and is not binding on FDA or the public. Therefore, states need to enact laws acknowledging the FDA’s new guidance rules in order for stakeholders to feel comfortable donating to any third-party reimbursement fund, says Dana Dornsife, CEO of the Lazarex Cancer Foundation.

The Lazarex Cancer Foundation wrote the bill’s language and is presenting it to legislatures in states with existing cancer clinical trials, a larger population of patients in need of financial assistance, or where its IMPACT program exists or will soon open. The Clinical Trial Participation Act will help raise awareness of clinical trials and the needs of cancer patients, and to declare that a particular state is “clinical trial friendly,” says Dornsife.

IMPACT (Improving Patient Access to Cancer Clinical Trials) which launched in 2018, is a Lazarex program focused on recruiting for clinical trials locally, improving trial diversity, increasing community place-based engagement, and offering financial reimbursement at the time of consent for travel expenses associated with cancer clinical trials. Reimbursement covers plane tickets, hotels, gas, tolls, cabs, and parking for the patient and a companion.

“Historically, there has been hesitancy to cover these expenses because they have been considered by the FDA to be coercion or inducement,” says Dornsife. “Internal review boards at medical facilities where patients are being seen are also concerned about the optics of potential inducement or coercion. Now, cancer patients can be reimbursed for those out of pocket expenses openly without concern of fines or pushback from the FDA or other regulatory bodies for doing so.”

The primary goal of the legislation, says Dornsife, is to meet the unmet needs of underserved and economically challenged cancer patients of all demographic groups and increase diversity in clinical trials. California, Pennsylvania, Texas, Wisconsin, and Illinois have passed this legislation. New York, Ohio, Maryland, and Florida plan to introduce legislation; Massachusetts is considering the bill.

“Poverty disproportionately affects people of color,” says Dornsife. “There is a greater deal of challenge from people in minority communities. This legislation allows us to focus on at-risk patients, remove finances as the primary barrier in trials, get them where they need to be when they need to be there, and not worry about covering costs. We always work for the benefit of the patient.”

The 2019 minority participation rates in clinical trials at IMPACT at the University of Southern California (USC) and at University of California at San Francisco (UCSF) were 64%, including a 97% increase in Hispanic and 9% increase in Asian participation rates from 2018. Nationally, the minority participation rate is 5%.

57% of patients Lazarex serves are in households earning $25,000 or less.

Dornsife sites a national study that found households with annual incomes of less that $50,000 are 30% less likely to participate in clinical trials. “They can’t handle the burden of cancer on top of poverty,” says Dornsife. “They don’t have transportation and can’t pay out-of-pocket expenses. When we offer a patient financial reimbursement, the trials immediately get higher levels of participation. That’s where we are seeing huge increases in demographics.”

While the legislation allows pharma companies to reimburse participants, many still do not; patients, therefore, may choose to work with third parties, which set their own reimbursement guidelines. Lazarex reimburses at seven times the government poverty line, awarded on a sliding scale based on household income, and continues for the duration of the trial.

COVID-19 has impacted trials and particularly patients, who are already emotionally stressed and physically immunocompromised. Patients are now visiting their clinical trial teams through telemedicine rather than in person; chemotherapy and lab work are completed locally rather than at trial sites hours away. Some patients who need to visit the trial site must drive, as planes and trains are no longer options. “The trial now goes to the patient, not the patient going to the trial,” says Dornsife.

As a result, virtual and hybrid trials may surge. While this will reduce costs and increase patient participation, it also means principle investigators will need to relinquish at least partial control and develop a symbiosis with community medical professionals. “Doing this is asking people to change, to do things differently,” says Dornsife. “Clinical trials have a high degree of scientific rigor that need to be upheld. You can understand why there is a hesitation to give up control.”

The public is also learning about the importance of clinical trials as a result of the pandemic. “Now trials are relevant to almost 100% of the population,” says Dornsife. “Now everyone is hearing ‘clinical trials’ on TV and that in order to get a drug approved and a vaccine, we must have clinical trials. It’s a great time for us (at Lazarex) to help people understand the challenges of participating in a clinical trial and what it means to be a patient, whether it is financial constraints or joining a trial across the country.”

Meanwhile, Dornsife hopes the Clinical Trial Participation Act will eventually pass in all 50 states, granting all cancer patients, regardless of socio-economic backgrounds, access to clinical trials.

“One-third of the population will have cancer, which means either you will have it or someone you know or love will have it,” says Dornsife. “Then it becomes relevant. We are trying to elevate this relevance based upon the sensitivity right now people have toward the importance of clinical trials.”

Correction: A previous version of the story stated that Minnesota had also passed versions of the legislation. That was not correct.