Can the Clinical Trial System Be Cured in Time to Save Lives?
WHY YOU SHOULD CARE
Laboratories, research initiatives and companies are partnering to ease access to clinical trials.
There may be no single cure, but there are nearly as many cancer treatments as there are types of the disease. Since 1975, the five-year survival rate for all cancers has risen by 36 percent. Yet researchers have struggled with a far more fundamental moonshot than developing innovative ways to treat cancer: Their challenge has been to test new treatments. Now, that might be about to change.
More than four out of five cancer clinical trials fail because researchers simply cannot recruit enough patients. Fewer than 5 percent of cancer patients are enrolled in clinical trials, partly due to restrictive criteria for selecting patients that doctors say are often counterproductive. Worse, there is no central resource through which doctors and patients can find up-to-date information on nearby trials for which patients might be eligible. Transportation back and forth from clinical trials and mistrust also deter many patients. But a growing band of laboratories, research initiatives and companies are now battling to make access to information about — and participation in — cancer clinical trials easier in a bid to revolutionize a key bottleneck in oncology research. Their efforts could also hold implications for clinical trials across other fields of medicine.
The Levine Cancer Institute, the American Society of Clinical Oncology and the nonprofit Friends of Cancer Research are working with the FDA to convince the agency to accept looser regulations on clinical trial requirements. In 2016, the Levine Cancer Institute piloted a system called EAPathways that suggests clinical trials and treatment procedures to physicians with near-real-time updates. They’ve since demonstrated lung cancer clinical trial enrollment that’s six times higher than the national average. Late last year, BreastCancerTrials.org launched MBC Connect, a platform that provides patients with a searchable database on trials for advanced-stage breast cancer.
The biggest issue is that patients just don’t know about clinical trials.
Elly Cohen, BreastCancerTrials.org
Then, earlier this year, the Biden Cancer Initiative began working on the most ambitious project yet, with nine tech and health care groups (including BreastCancerTrials.org, IBM Watson Health and Massive Bio). The coalition aims to create a central database for all oncology clinical trials, which would function like Sabre — the company that collects airplanes’ data and relays it to sites like Kayak, where you can search for flights. Called the Oncology Clinical Trial Information Commons (OCTIC), it will collect standardized information on clinical trials. Doctors could access information on trials’ locations, eligibility criteria and procedures through patients’ electronic health records — as could patients, by interfacing on sites such as BreastCancerTrials.org. Information about clinical trials, restricted for decades, might open up like never before.
“The biggest issue is that patients just don’t know about clinical trials,” says Elly Cohen, program director of BreastCancerTrials.org.
That’s because, while well-funded hospital networks like Levine have implemented up-to-date databases of trials in their network, raising a national database takes a village of tech companies and health care groups. Right now, the closest thing to a central resource on clinical trials in the U.S. is ClinicalTrials.gov. Indeed, it is a massive international resource. But the site is meant only for clinical trial providers to register with the U.S. federal government, not for advertising to patients. The information offered is largely unstandardized and rarely updated. Edward Kim, a senior oncologist at the Levine Cancer Institute, says he has on multiple occasions gotten inquiries from desperate patients about clinical trials listed on the site, which he conducted years earlier, at a different hospital. Globally, the nearest project to the new ones being attempted is the World Health Organization’s International Clinical Trials Registry Platform, but like ClinicalTrials.gov, it’s a registry, not a real-time, searchable database.
To be sure, easing up regulations governing clinical trials is controversial. Dubious clinical trials from the past, such as the Tuskegee syphilis experiments conducted on African-American sharecroppers in Alabama between 1932 and 1972, remain imprinted in the minds of many patients.
Convincing patients about fully legitimate clinical trials is often difficult too. Most cancer patients consult their local oncologist — but would need to work with a different set of doctors involved with the trials, mostly working with larger companies or research institutes. The realities of being passed off to another oncologist, traveling to a more distant location, feeling like a number and misnomers (such as receiving a placebo, which means you won’t get any treatment), Cohen says, lead many people to avoid clinical trials.
But without easier norms and greater access to information about them, cancer clinical trials — instead of being the cutting edge of research — are often where potential cures go comatose, say many experts.
For instance, people with several other diseases — such as HIV — can’t participate in cancer clinical trials. That’s “stupid,” Kim says bluntly. Sure, those taking drugs that the clinical trial could interfere with must stay away, but a blanket ban reduces prospects of a heterogeneous sample of patients in the trial that actually mimics the real world, Kim suggests. Narrow eligibility criteria and the homogeneous samples they create amplify any signals of drugs’ effectiveness — so drug companies may not mind. But research for a real cure suffers, he argues. For instance, biomarkers that have been proven unreliable for judging the kidney health of African-Americans have at times been unintentionally used to keep Black men out of cancer clinical trials — even though they’re the demographic most vulnerable to prostate cancer.
“My goal is to see less than 10 eligibility criteria,” says Kim. “Nothing frustrates a health professional or patient more than when you think you have a trial with an interesting drug to offer a patient, then you … find out they’re not eligible.”
The efforts to build a central database of cancer clinical trials are equally critical. Many oncologists still have to rely on word of mouth to find out about clinical trials for which their patients could be eligible. Even pharmaceutical companies routinely hire clinical trial patient recruitment companies — essentially promoters or advertisers for clinical trials — to get the word on their trials out to patients and doctors alike.
The winds of change are also evident in efforts to help patients overcome their fears and hesitations. At oncology conferences, throw a stone and you’re now as likely to hit a seminar on patient navigators — specialists of a similar background as patients and trained to help guide sufferers through their treatment and trial options — as one on a new drug. Several hospitals, health care groups and companies, including Lyft and Southwest Airlines, have also started programs offering cancer patients free transportation to treatment or trials.
At a rally in June for his 2020 presidential campaign, former Vice President Joe Biden declared that a cure for cancer would be found under his leadership. And the Biden Cancer Initiative — which in July suspended its other operations because of the election campaign — has made clear that the database project will continue. That too is part of the recognition of a deceptively simple first step toward a meaningful moonshot: letting people know their options.