Digging into the Data on Low Enrollment Rates for Cancer Trials

Dr. Niraj J. Gusani, Professor of Surgery, Penn State College of Medicine

Patient enrollment in clinical trials as the first course of treatment after cancer diagnosis is low, despite the fact that enrollment may increase life expectancy, according to researchers at Penn State.

Dr. Nicholas G. Zaorsky, an assistant professor of radiation oncology with the Penn State College of Medicine, led a team of Penn State Cancer Institute researchers in analyzing data from more than 12 million patients with 46 different types of cancer between 2004 and 2015 in the National Cancer Database. The researchers found that only 11,576 (0.1%) of those patients were enrolled in clinical trials as their first course of therapy following diagnosis.

According to Penn State’s Dr. Niraj J. Gusani, professor of surgery and senior author of the study, the low enrollment is troubling because clinical trials may be beneficial for patients.

“Major advances in cancer treatment have been supported by clinical trials,” Gusani said. “By volunteering to participate in a trial, patients may help further the field of research and gain access to new treatments.”

The researchers found that patients with cancer treated in clinical trials, when matched and compared to similar patients not treated on trials, lived longer. They report that patients with cancer in clinical trials at the first course of therapy had a median survival of seven and half months more than those not enrolled in a trial. They published their findings in the Journal of the National Comprehensive Cancer Network in November 2019.

While the survival trend was evident across cancer types, the researchers said that this may not necessarily be true for the general population. In their analysis, they determined that the patients who enrolled in clinical trials at first course of therapy tended to be white males with private insurance, with metastatic disease, who had no other chronic medical conditions, and who were treated at academic medical centers.

“If clinical trials are going to be used to determine standards of care for the general population, then the study participants need to be representative of the general population—and this study shows that often this isn’t the case,” Gusani said.

According to Zaorsky, increasing patient enrollment in clinical trials cannot happen without first improving the infrastructure of clinical trial design and management.

“The increased level of quality control in clinical trials may be beneficial for patients,” Zaorsky said. “Patients who go onto a clinical trial must be treated per protocol, meaning that there are many quality measures that must be met, and that there are many other healthcare providers looking over the patient’s care.”

Edited by Gary Cramer