Cancer Groups Tap The Crowd To Boost Clinical Trial Participation
Pushing a cancer therapy through clinical trials typically takes years and millions of dollars. But before trial organizers can even begin evaluating a drug’s safety and effectiveness in humans, they must first, of course, sign up patients to test it.
Easier said than done, it turns out.
At least a quarter of cancer clinical trials, according to some studies, don’t even get completed because they fail to recruit enough volunteers. No tests, no data to show the FDA, no approved drug. That means patients miss out on a potentially life-saving (or, at least, life-extending) treatment.
Despite the stakes, only a tiny fraction—estimates vary, but somewhere around 3 percent—of eligible cancer patients actually participate in clinical trials. It’s no secret, and the various underlying reasons have been widelydocumented and discussed for years (more on those later), but it’s an issue the medical community has yet to solve.
Now, a group of cancer foundations and life sciences companies is soliciting fresh ideas through the Clinical Trial Innovation Prize, an online campaign to crowdsource actionable methods that help double the participation rate in clinical trials of cancer treatments and diagnostics.
The campaign, hosted on the HeroX website, will award $75,000 over two phases: an idea-generation competition and a proof-of-concept challenge that will reward the project that demonstrates the most impact on clinical trial participation. The initiative is led by Free to Breathe, a Madison, WI-based lung cancer organization, and The Bonnie J. Addario Lung Cancer Foundation, based in San Carlos, CA. Genentech and Celgene are also providing funding.
Organizers are hoping to hear from a variety of people—not only healthcare professionals, but also students, entrepreneurs, patients, and more. As of this writing, 29 people from regions as far-flung as New York and Nigeria have submitted ideas. “We feel like some of the greatest ideas can come from anywhere,” says Sherie Reinders, Free to Breathe’s chief operating officer. “We didn’t want to limit it to people who work in the medical community.”
Some of the factors in low cancer clinical trial enrollment, the crowdsourcing campaign’s organizers say, include lack of awareness about the trials among patients and physicians and “procedural inefficiencies” that can make in enrolling in a trial difficult.
One of the biggest barriers is the location of the trials. About half of U.S. clinical trials happen in just 10 states, primarily places where the largest research hospitals reside, such as California, Massachusetts, New York, and Texas, says Bonnie Addario, a lung cancer survivor and founder of the foundation that bears her name. But around 85 percent of cancer patients are treated in their local communities, not academic medical centers.
That means cancer patients who might benefit from a clinical trial often can’t participate, at least not without breaking the bank on travel expenses, Addario says.
“The system is set up imperfectly,” she says. “Patients really do want to participate in clinical trials. But getting access to them is difficult.”
One thing Addario suggests is clinical trial participants could have the necessary blood, urine, and other tests done at their local hospital, which could share that data with the medical center spearheading the trial. That might reduce the number of times the patient needs to travel to the far-away research institution. “You’re allowing the community hospital to take part in the process, but not take over the whole expense of the trial,” she says.
The National Cancer Institute is trying to improve access to cutting-edge treatments and clinical trials in smaller communities nationwide through its NCI Community Oncology Research Program (NCORP). That program, which received $93 million in annual funding for five years, doled out 53 grants to research sites last year.
But that’s not enough funding to solve the problem, says Michael Thompson, a Milwaukee oncologist with Aurora Health Care who closely follows trends in clinical trials. (Thompson’s employer was one of the NCORP grant recipients.) Increasing the $93 million by double or more “would not make a blip” in the federal budget, but it “would allow adequate research staffing, adequate funding for the things we do, would incentivize clinical trial participation,” Thompson argues. If more “money was put into it, everything else I think would flow better.”
But money can’t fix some of the more complex reasons behind the low clinical trial participation rate, such as overcoming “stigmas and misconceptions” some patients and doctors have about clinical trials, the crowdsourcing campaign’s organizers say.
“I think there’s a disconnect between the idea of clinical trials as treatment options, albeit complex ones, and the idea of clinical trials as experiments. They are both,” says Smart Patients co-founder and CEO Roni Zeiger, a doctor and one of the crowdsourcing campaign’s judges. “But I think the language and the culture around thinking of them as just experiments makes a lot of people uncomfortable with clinical trials and less likely to consider them when in many cases they should.”
Improved communication could help, Zeiger says. That’s something the former Google chief health strategist is trying to facilitate through Smart Patients, an online community for patients and caregivers affected by complex illness.
Zeiger believes patients need to be involved more closely and earlier in the clinical trial development process, applying the software industry’s mantra of “user-centered design” to healthcare.
“Can you imagine if the first time an end user provided feedback about the iPhone was when the iPhone was put on the shelves of the Apple store?” Zeiger says. “We can do a better job if we collaborate with patients when we’re making strategic decisions about what a new drug might be designed to do, about what our research priorities are, and about how to design the trial—not just asking patients to be involved when all the decisions have been made and it’s time to try to get the first patient into the trial. It’s too late.”
Zeiger thinks the crowdsourcing campaign could attract valuable ideas, but he cautions that “a thoughtful, but modest, effort like this” is unlikely to “solve a massive problem” by itself.
“I think this is an important step in understanding the kinds of ideas people may bring to the table, some of which will be excellent, and maybe even useful,” he says. “I’m confident that they will at least trigger others to generate additional ideas and start a series of conversations that will lead us to more collaboratively solve the many challenging problems that we face in doing better science.”
Thompson, the Milwaukee doctor who was not involved in planning the crowdsourcing campaign, thinks the project is an interesting idea. The keys, he says, will be whether contributors offer ideas that go beyond rehashing what the industry already knows about the issue—and whether the effect of the ideas that get put into practice can be objectively measured. But at the very least, “it’ll probably get people unaware about the barriers [to clinical trial participation] talking about the barriers,” he says.