Each time Rhonda Long gets treatment for her bile duct cancer, it costs her $1,000, and not a penny of that is for the medicine she is using. That is just the cost of travel. Rhonda receives her treatment through a clinical trial, and to participate in the trial, she must fly from Ohio to Boston once a month, where that clinical trial is being conducted.
Paying that $1,000 monthly expense on her own would likely send Rhonda’s family of 4 into financial ruin. Fortunately for them, she found Lazarex Cancer Foundation, which is now providing the reimbursement for her travels so she could continue to participate in the clinical trial.
Lazarex Cancer Foundation (https://lazarex.org/) is a nonprofit organization dedicated to improving the outcomes of cancer care. The foundation helps patients with cancer identify clinical trial options and provides patients assistance with travel costs for participation in FDA-approved clinical trials.
The financial assistance Rhonda receives levels the playing field for her, as it does for other patients with cancer who participate in clinical trials and receive reimbursement for travel expenses. Travel reimbursement allows people to say “yes” to potentially life-saving treatment, regardless of their socioeconomic status, instead of saying “no” because the out-of-pocket price tag of participating in a clinical trial is simply too high.
The Importance of Clinical Trials
Rhonda and her family are not the only ones affected by this problem. This issue is important to everyone: clinical trials are the key to the development of new therapies for cancer. Successful clinical trials lead to drug innovations and breakthroughs that benefit all of us. Without clinical trials, we will continue to lose more than 600,000 people in the United States to cancer each year.
But a clinical trial can only be successfully completed if it includes enough patients. Ideally, those enrolled in a clinical trial should represent a diverse group of patients that mirrors the diversity of the US population. Sadly, this is usually not the case. In fact, almost half of all clinical trials fail, or need to be extended, not because the treatment does not pan out, but because the researchers cannot enroll enough patients.
Currently, only about 5% of the patients who are enrolled in clinical trials are from minority communities. Therefore, in addition to the attention of the medical community, this issue needs the attention of state and federal lawmakers, who should get involved in this topic. Why?
I asked myself—why is there such an intractable disconnect between patients with cancer who need to join a clinical trial to survive, and all the many clinical trials that need patients to participate in them to be able to succeed?
I did some digging to find the answers—2 starkly opposed observations rose to the top. First, the FDA had longstanding guidance language in place that discourages payment or reimbursement by drug companies to patients for participating in clinical trials, which was intended to protect those who are most at risk—primarily those from our communities of color—from the continued injustice of medical abuse.
Second, financial distress is a major concern for patients with cancer and is experienced by the majority of patients. These 2 factors together create a recipe for failure, and that is why we have such low completion rates for clinical trials, and such abysmally low enrollment rates of minority patients and lack of diversity in these studies.
Patients with cancer are stressed emotionally, spiritually, and financially. Because poverty disproportionately affects our communities of color, patients with cancer from within these communities are dealing with double jeopardy—poverty and cancer.
Ironically, the unintended consequence of the language of the FDA guidance resulted in negatively affecting the very people it was trying to protect: many minority people cannot afford to participate in clinical trials, and because of the FDA guidance language, had no remedy for that situation. Today, our dismal and unacceptable rates of minority participation in clinical trials reflect this.
I addressed this issue with the FDA, pointing out that for patients with cancer, clinical trials offer a lifeline, and we need to make that lifeline available to all patients with cancer, not just those who can afford them.
Out-of-pocket travel expenses are a barrier to clinical trial participation, especially for many minority members. Reimbursing patients for the expense of traveling to the clinical trial location does not induce a patient to participate for financial gain; it only levels the playing field and creates equitable access. I asked the FDA to consider formulating separate guidance specifically for reimbursement, hoping to create a more permissible environment for drug companies to provide support and a sustainable solution, by including reimbursement of travel expenses for all cancer clinical trials.
About the same time, I also went to the California State Capitol to bring attention to this issue. I thought that if I could get lawmakers to pay attention, perhaps we could raise awareness to this unmet need, and start by creating change in my own state. State legislation is critical to establishing the acceptance of reimbursement for patients, by the different bodies that are involved in clinical trials, including drug companies and Institutional Review Boards that provide the scientific basis for those trials.
Fast-forward to the fall of 2016. California passed the first Clinical Trials Act, known as AB1823, in the country,1 which aimed at raising awareness to the importance of clinical trials, the value of reimbursing patients for travel to clinical trials—especially for minority people and women—the need for diverse participation in clinical trials, and to create an environment that welcomes and encourages reimbursement in clinical research in a state that is rich with resources.
A Landmark Shift
This success was followed by a major change from the FDA in January of 2018, when it issued new guidance language.2 In this new guidance, the FDA clarifies that “reimbursement” is different from “payment,” and thus reimbursement was no longer seen as coercion or “undue influence” (on drug companies) but rather as a means to create parity and equal access to clinical trials for all patients with cancer.
Given the historical sensitivity around inducement, and because the healthcare industry has been conditioned to avoid universal reimbursement, it will take time for drug companies to accept this landmark shift in the FDA guidance, adopt this new vision, and be comfortable with the idea of reimbursement, even while clinical trials continue to fail, because they cannot recruit enough patients.
Patients with cancer continue to die in large numbers, many because they simply cannot afford the monthly travel expenses to get to a clinical trial with a medication that could potentially save their lives.
So, I have kept up the fight. After our success with California state lawmakers, I took the issue to other willing states, with the hope of having lawmakers reiterate the FDA guidance and issue new state legislations. In the past 2 years, we have successfully passed similar legislation in Pennsylvania, Texas, Illinois, and Wisconsin, and most recently Massachusetts, and new legislation has been introduced in Florida. Ohio, New York, and Maryland are next.
IMPACT: Improving Patient Access to Cancer Clinical Trials
California is now reaping the benefits of the AB1823 rule. Just 2 years after then-Governor Jerry Brown signed the bill into law, Lazarex Cancer Foundation launched its Improving Patient Access to Cancer Clinical Trials (IMPACT) program at the University of California-San Francisco Helen Diller Cancer Center and USC Norris Comprehensive Cancer Center with a major pharmaceutical company, Amgen, as its founding sponsor.
Recently, 2 other major drug companies, Merck and Genentech, have also invested in our IMPACT program. Through IMPACT, patients who enroll in a clinical trial are offered reimbursements at the time of consent for their travel to the clinic where that clinical trial is being conducted. This allows them to enroll and stay enrolled in the clinical trial without financial concern over travel.
IMPACT is showing success: our preliminary unpublished results show that 63% of our participants are minority patients, and about half (53%) of them are from households with an average annual income of less than $25,000.
Clearly these are patients who could never consider participating in a clinical trial without receiving reimbursement for their travel expenses.
Helping patients with cancer achieve better health outcomes and addressing health disparities are our challenges. Getting patients to their clinical trials—and making sure we are helping all patients, regardless of their social or economic status—should not be a challenge. There are solutions, and it is time to embrace them.
- California Legislative Information. AB-1823 California Cancer Clinical Trials Program. (2015-2016). Assembly Bill No. 1823. Chapter 661. September 26, 2016. https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201520160AB1823.
- Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice. Payment and Reimbursement to Research Subjects. January 2018. www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects?utm_campaign=Payment%20for%20Research%20Subjects%20Information%20Sheet&utm_medium=email&utm_source=Eloqua.
FDA: Racial and Ethnic Minorities in Clinical Trials
Lazarex Cancer Foundation
National Cancer Institute