On August 14, 2018, we discussed patient participation in cancer trials on “The Business of Healthcare,” on Sirius XM Business Radio powered by the Wharton School, channel 132. My guests were Joseph Unger, PhD, Fred Hutchinson Cancer Research Center, University of Washington; Arturo Loaiza-Bonilla, MD, Vice Chair of the Department of Oncology, Cancer Treatment Centers of America (CTCA); and Grant Huang, PhD, Director for the Cooperative Studies Program, U.S. Department of Veteran’s Affairs (VA).
Fewer than one in twenty cancer patients enroll in a clinical trial. Low accrual rates in trials is a major barrier to progress in cancer therapy. The data, however, indicate that a clinical trial system that enrolls patients at a higher rate produces advances at a faster rate—including longer survival and reductions in mortality. Interestingly, 70 percent of cancer patients are inclined or very willing to participate in cancer trials. So where is the disconnect?
Barriers to participation discussed during the segment include structural challenges, such as access to a cancer center, given the fact that clinical trials are mainly performed at academic medical centers that patients may not have access to. In addition, clinical barriers such as very narrow inclusion and exclusion criteria (which limits the number of patients who can enter a trial), income (those who make less than $50,000 a year) and age (elderly people are less likely to participate) contribute to low rates in patient participation.
So what is being done to increase participation? Recently the American Society of Clinical Oncology (ASCO) initiated the Targeted Agent and Profiling Utilization Registry Study (TAPUR). This study is paid for by ASCO and is focused on performing trials in the community setting, where most patients reside. Patients involved in the TAPUR study have their cancer genetic make-up profiled for the identification of mutations. These mutations can be treated by existing FDA-approved drugs. Patients are evaluated rapidly for a response of the drug in treating the mutation. If the patient has multiple mutations, combinations of drugs can be evaluated. This is an important step in increasing enrollment for several reasons: there are no costs to the patient; access to cancer medication is easier; there are lower barriers to enroll in the trial (it’s a registry, not a formal randomized trial); and it uses precision medicine diagnosis and treatment techniques. To date, the CTCA has been the most successful center in the country in enrolling patients in TAPUR.
Recently, the VA partnered with the National Cancer Association (NCA) to create an initiative with the goal of accelerating trial enrollment across the board. This VA patient enrollment initiative is planned to go live this fall, and will have 12 participating VA centers. Again, this initiative is meant to enroll VA patients in cancer trials with the goal of reducing some of the barriers addressed above.
Ultimately, these initiatives will be deemed a success if enrollment in cancer trials increases. The panelists suggested that the benchmark will be getting 10 to 15 percent of cancer patients enrolled; in essence doubling or tripling the current enrollment rate. Doing so would provide very meaningful advances in patient survival and quality of life in addition to increasing the speed of cancer treatment advancement.
The entire discussion on cancer trial participation can be heard here: