AN FRANCISCO — An ambitious startup aimed at connecting cancer patients with clinical trials launched on Thursday, one that is betting a smartphone app can help close the notorious gap between patients seeking experimental treatments and cancer centers ready to offer it.
Driver, as the company is called, will charge cancer patients $3,000 upfront plus a $20 monthly fee — all out of pocket — for a service that analyzes their tumor sample and their medical record. Driver uses that information to recommend options for both approved treatments and clinical trials as well as facilitate referrals via an app that patients can access on their phones.
The startup is being launched with backing from Hong Kong’s richest man, Li Ka-shing, and with the support of other high-profile figures, including Jennifer Doudna, the University of California, Berkeley, scientist, who sits on Driver’s board. More than 30 cancer centers in the U.S., China, and Singapore — including top hospitals like Stanford, Mayo, and Cleveland Clinic — have already signed up to give their clinicians access to another version of the app, so that they can help patients navigate treatment options.
The idea is to address one of the most frustrating problems in health care. Only about one-seventh of adult cancer patients who are eligible to enroll in clinical trials actually sign up. And at the world’s top cancer centers, many studies get shut down because they can’t enroll enough patients; some trials can’t enroll anyone at all.
But it remains to be seen whether Driver will be able to achieve its bold ambitions. Clinicians are already inundated with technology, and they’ll have to embrace yet another piece of software if Driver is to succeed.
It’s also not clear whether Driver will be able to make enough money to build a sustainable business: The company is trying to convince patients already burdened by the costs of their disease to pay for its service. (It’s also trying to persuade employers, insurers, and pension funds to pay to give their members access to another version of the app aimed at healthy people that gives tips about prevention and reminders to schedule screenings like a mammogram or a colonoscopy.)
Driver’s executives believe the hurdles are surmountable.
When it comes to the American health care system, “everyone has decided that the problem is cost … but at its core, we have a performance problem here,” said Driver CEO and co-founder Dr. William Polkinghorn, a radiation oncologist by training who was previously on the faculty of Memorial Sloan-Kettering Cancer Center.
“We want Driver for Clinic to become the Bloomberg terminal for every oncologist around the world,” Polkinghorn said.
As evidence of the company’s high-profile backing, Driver arranged to get the director of the National Cancer Institute and the head of clinical research at the prestigious Massachusetts General Hospital Cancer Center on the phone with STAT to speak to the broken marketplace for clinical trials and vouch for Driver’s potential to help fix it.
NCI Director Dr. Ned Sharpless spoke in positive terms about Driver, saying he was hopeful that the company’s product would help with the metric NCI cares most about: increasing the number of patients enrolling in trials being run by NCI and its designated cancer centers. But he told STAT that Driver “has one potential problem that concerns me, which is the potential to create disparities.” He added: “If there’s this access to better care because patients can pay an extra bit and get this double secret better treatment, then that would be bad for the majority of patients that couldn’t afford the extra treatment.”
(Sharpless said he was pleased, though, that Driver had anticipated this problem by creating a charitable arm.)
Driver is far from the first effort to better match patients to clinical trials.
There’s the government’s trial registry clinicaltrials.gov, as well as a cancer-specific search tool. Clinical researchers are mandated by federal law to register Phase 2 and Phase 3 clinical trials, but in practice, the sites have significant limitations for patients and clinicians trying to navigate clinical trial options. Some trials don’t get listed at all. Many get listed months after they begin enrolling patients, or remain listed after they’ve shut down. And even those trials that get listed promptly often don’t post crucial information about eligibility requirements.
Other startups, too, have tried to take on the problem. For example, Antidote.me, a clinical trial matching service backed by Merck’s venture capital arm, makes money by charging referral fees to drug companies for trials testing their drugs and charging licensing fees to hospitals and clinics to use their service.
Driver’s tack of charging patients directly is more unusual. The number of patients who’ve tried it since the app became available in April 2017 — the company was in “stealth mode” until Thursday — is in the hundreds, Polkinghorn said. Patients can pay to get access to Driver’s service with their own money or via a special campaign on the crowdfunding website GoFundMe that can be set up to send the funds directly to Driver.
Driver has used much of its funding to build its own automated machines — one in San Francisco and another in China — to analyze patients’ tumor samples, which Driver arranges to get shipped from the hospital where patients got their initial tumor biopsy. Driver’s machines analyze the genetics and other molecular characteristics of the tumor.
For each of the cancer centers Driver partnered with, the company uploaded the hospital’s internal registry of clinical trials into its system. It was an exhaustive process: The company started by scraping trials listed on clinicaltrials.gov, and filled in the substantial gaps by going into the hospitals themselves. “We would find their clinical trials on everything from whiteboards to Google Docs to Excel sheets,” Polkinghorn said.
Consider the existing process at the cancer center at Massachusetts General Hospital. Each group of oncologists focusing on a specific disease — for example, breast cancer — build a roster of trials that they rank based on promise. They compile the list in a working document, said Dr. Keith Flaherty, the medical oncologist who directs clinical research there.
Driver has uploaded the information in those working documents into its app and getting Mass General ready to soon start using it.
For support that its approach works, Driver points to a study it conducted looking at 21 patients with advanced prostate cancer enrolled in NCI trials. Driver’s method correctly predicted that 20 of them were “potentially eligible” for the trial they ultimately enrolled in. The company presented that data this spring at the annual meeting of the American Society of Clinical Oncology.
An early peek into how Driver’s product is being used can be found in its charitable arm, Driver for All. One of the projects that Driver is fully funding under the program has begun matching patients being treated at Howard University to clinical trials at NCI’s in-house cancer center in Bethesda, Md. Many of the patients involved are underrepresented in clinical research, such as African-American men.
Among them is Anthony Young, a 50-year-old landscaper from Washington, D.C. He was diagnosed 18 months ago with prostate cancer that’s now classified as high-risk stage 2, a point at which the cancer is curable and confined to the prostate but has a risk of spreading.
Howard oncologists have used Driver’s app to help Young narrow down his potential clinical trials options to three being run at NCI. He’s narrowed that down further to two options, because he prefers a study approach deploying radiation. He’s currently undergoing biopsies and scans that will help decide which clinical trial he’ll be able to enroll in.
“I want the best treatment possible for myself,” Young said, “and to get back to living my life.”