Lazarex: New FDA Guidance Means Hope For Cancer Patients
Increases access to cancer clinical trials among minority, elderly and low income populations
DANVILLE, Calif., Feb. 1, 2018 /PRNewswire-USNewswire/ -- The Food and Drug Administration has issued official guidance, giving the green light to reimburse patients for travel expenses to clinical trial sites. It allows all cancer patients access to potentially life-saving treatments.
Many cancer patients who fail standard treatment but are eligible for clinical trials offering potentially life-saving drugs must decide between living expenses and hope. Why? Because clinical trial sites are often inconveniently located. Before now, reimbursement of travel expenses to get to those sites was considered coercion or "undue influence". Therefore, only those wealthy enough to pay for travel had access.
Lazarex Cancer Foundation brought this problem to the attention of the FDA. Lazarex is the only organization in the country helping patients find clinical trials and reimbursing them for travel expenses, and has been working to create an even playing field so ALL patients have access.
Lazarex Founder Dana Dornsife says, "If we don't have fully enrolled clinical trials with a diverse pool of patients, a cure is not possible. Clinical trials are the pathway to new treatments. But when you have only 3% of cancer patients enrolling in clinical trials and about 50% of clinical trials failing because they can't enroll enough patients, we have a broken system. That's why Lazarex took this issue to the FDA. We are pleased the FDA has issued this guidance."
The new guidance includes the following critical language:
"FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence."
Full FDA guidance language here.
INTERVIEW OPTIONS:
1) The patient
Brittani Powell, diagnosed with giant cell tumor at 12 years old, was given 6 months to live. Her mom found a clinical trial in Los Angeles, 300 miles from her Sacramento home, but the cost of travel to get there was a hardship and meant Brittani would have to drop out. Fortunately a nurse found Lazarex. The Foundation reimbursed Brittani's travel expenses, the trial saved Brittani's life, and the FDA approved the drug (denosumab) she was taking. Now 21, Brittani is a student at Sacramento State, studying to become a doctor. More patients here
2) Congressman Pete Sessions (R-TX) who, along with his colleagues and other stakeholders, worked for years on this issue to make the case to the FDA that reimbursement of a patient's direct expenses is not inducement but rather a recruitment incentive, enabling more patients to participate in cancer trials.
3) Congressman Jamie Raskin (D-MD) says: "This FDA guidance is a big step in helping to accelerate cancer detection, research, and care. Unfortunately for many cancer patients, travel costs are a significant barrier to participation in these life-saving trials. That is unacceptable. We should ensure that every cancer patient, regardless of his or her economic situation, should be able to participate."
SOURCE Lazarex Cancer Foundation
Share this article