To Get Patients into Clinical Trials, We Need to Get Clinical Trials to Patients

The other day, an Agios employee, Holly, took an Uber to make a midday meeting. The driver mentioned that he was from out of town and welcomed any shortcuts to get to their destination. She asked where he was from, and during her brief ride, she learned that he drove an elderly woman from New Hampshire to Boston twice a week so she could participate in a clinical trial for a new cancer treatment at Mass General Hospital. It was a two-hour trip each way, and the treatment took four hours, so he filled that time giving rides close to the hospital.

For the rest of the day, this woman’s story clung with Holly, who found herself wondering if she had friends or family with her at the hospital, what investigational medicine she was taking and if it made her sick on the long drive home. When Holly shared her experience with me, despite the pangs of sympathy, I found solace in the fact that this woman lives within driving distance of one of the leading cancer centers in the U.S., giving her access to the most advanced cancer care and potentially lifesaving clinical trials.

Though the time commitment is significant and the cost of transportation is likely high, her situation is a stark contrast to the estimated 85 percent of cancer patients around the country who receive care in a community setting, where clinical trials are less likely to be offered. I’ve written before about my own experiences with the harsh emotional reality of participating in studies of new treatments, but low enrollment can also be attributed to geography. The truth is, most patients don’t live near a hospital or academic center that offers clinical trials, which can often be life-saving options for people who have already received approved therapies. Recent studies suggest that outcomes can vary widely depending on where patients receive care.

There are many factors driving the inequities between cancer care and clinical trial access at academic health centers vs. community hospitals – including infrastructure costs, required FDA guidelines for clinical trials, necessary staff support, etc. Bridging that divide is something a colleague and friend of mine, Keith Flaherty, M.D., has spent much of his career trying to address. Dr. Flaherty is the Director of Developmental Therapeutics Clinical Research at the Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School. He also serves as the principal investigator for a clinical trial called NCI-MATCH, which is a study launched in August 2015 that analyzes patients’ tumors to determine whether they contain gene abnormalities for which a targeted drug exists and assigns treatment based on the abnormality. This study brings genomic testing and access to 30 targeted therapies to 6,000 patients at hundreds of hospitals and more than 1000 healthcare locations across the U.S. at no cost to the patient or treatment center.

I spoke with Dr. Flaherty a few weeks ago to get his perspective on NCI-MATCH and the future of clinical trial access outside of big research centers. Here’s what he had to say.

David: What does the future look like for clinical trials over the next few years?

Dr. Flaherty: It’s suffice to say there’s a big gap and a big unmet need, and we must figure out how to move forward given that NCI-MATCH is about to end and a large clinical investigation community is going to lose access to genetic testing and clinical trial options. I recently co-founded a company called Strata Oncology, which aims to potentially perform an NCI-MATCH-like function. We’re focusing on driving clinical trial participation in regional networks outside of academic medical centers, which allows patients to stay in their community and creates a much more efficient process for matching them to clinical trials of targeted therapies.

David: Certainly this addresses one of the bigger issues of identifying patients for biomarker-driven studies, which is critical. How has NCI-MATCH created the infrastructure in smaller community settings to make it easier to put a patient on a study and/or get a sponsor to use a small hospital that may only bring in one or two patients?

Dr. Flaherty: Providing small hospitals with the genomic tests to identify biomarkers is pretty straightforward and a good place to start. Creating the necessary clinical trial infrastructure piece is doable. It just requires stripping out some of the bells and whistles. Part of this is reducing the amount of data that these hospitals are required to collect for trials. With fewer resources, community centers can only do so much, so studies have to be structured in a way that allows them to capture registration-quality data, which isn’t feasible if they’re being asked for 1,000 data points per patient.

David: As you look ahead of the next 5 years, in terms of a change to the model and how we conduct clinical trials, do you believe we’ll see more biomarker-driven trials being offered in communities?

Dr. Flaherty: I do believe that some version of democratizing clinical trial access will happen. I think it has to start with a coalition of sponsors who are looking for sparsely distributed, genetically defined patients in order to make it reasonably efficient. Together, we need to figure out a geographically smart way to get these clinical trials to where patients are, and streamline what we’re asking for in these community settings. This could easily double the percentage of patients who enroll in trials nationwide.

For the benefit of the millions of people with cancer who are or will be treated in a community hospital, I hope Dr. Flaherty is right.