With more than 1,100 medicines in development to treat cancer, the biopharmaceutical industry is poised to build on the remarkable progress that’s been made in recent decades against this terrible disease. Proving through clinical trials that potential new medicines are safe and effective is an essential part of bringing these treatments to patients. But trials can succeed only if enough patients participate, and they can realize their full potential only if participants accurately reflect the population of patients living with or at risk of disease—and there we are not making nearly as much progress as you might think.
For Example:
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Thirty-seven percent of clinical trials are seriously under-enrolled, and 11 percent fail to register even a single participant.
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Just 6 percent of eligible US patients enroll in a trial.
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One-third of clinical trials that led to new cancer drugs approved between 2008 and 2018 did not report on the race of trial participants—and among those that did report on race, African-Americans constituted just 3 percent of trial participants and Hispanics just 6 percent—far lower than their shares in the total US population or among overall cancer patients.
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A 2015 study found that households making less than $50,000 annually were 30 percent less likely to participate in clinical trials than higher-earning households.
Clearly, the cultural and economic barriers to joining clinical trials can be significant. Many cancer patients who have failed on standard treatment are never even told about available trials—or informed that they might be eligible to enroll. In addition, trial sites are often inconveniently located, making participation logistically and financially challenging. This can discourage many people from taking part, which in turn can jeopardize trials and delay access to potentially life-changing breakthroughs. Sadly, many cancer patients are in such poor health that they simply don’t have time to wait.
“Cancer doesn’t discriminate,” notes Dana Dornsife, founder of the Lazarex Cancer Foundation, a nonprofit working to improve patient access to cancer clinical trials. “If the population of participants in clinical trials doesn’t mirror our actual population, then we’re not developing drugs for everyone. We have patients who are dying because they don’t have access to clinical trials, and we have clinical trials that are dying because they don’t have access to patients.”
This is an important issue for Amgen—and for the patients we serve. One in five cancer patients in the US already receives an Amgen medicine, and we are advancing an extensive pipeline of potential new therapies for difficult-to-treat cancers. We are committed to making continued progress against this devastating disease, and we want as diverse a range of patients as possible to have the opportunity to join us in the fight through their participation in our clinical trials.
To this end, Amgen is a founding sponsor of Lazarex’s IMPACT (Improving Patient Access to Cancer Clinical Trials) program, which aims to increase enrollment and retention of cancer patients—especially minorities—in clinical trials by expanding awareness of trial opportunities, alleviating financial barriers, and helping patients navigate the often-cumbersome clinical trial process.
We also know that four-fifths of cancer patients in the US are treated in community clinics. To give these patients—many of them from lower-income backgrounds—more opportunity to participate in our clinical trials, we recently established the Amgen Community Oncology Research Collaborators program. This initiative will make it easier for community oncologists at more than 200 sites across the US to refer their patients for participation in studies of Amgen’s investigational cancer medicines.
Clinical trials are critical to developing new cancer treatments, and they can provide a desperately needed lifeline for patients who are running out of options. With more than 600,000 Americans still dying from cancer each year, we should let nothing stand in the way of continued medical progress. I urge all biopharmaceutical innovators involved in cancer research to join Amgen in our efforts to improve access to cancer clinical trials and ensure that trial participants more accurately reflect the diversity of all those battling this devastating disease.