Penn State Cancer Institute led a study of over 12 million cancer patients between 2005-2015 and found that although cancer-based clinical trials may increase life expectancy, patient participation in that clinical research is extremely low. Moreover, to date, the overwhelming beneficiary of breakthrough cancer therapy-based investigational treatments tested in clinical trials are white males with private insurance who are treated at academic medical centers.
Led by Dr. Nicholas G. Zaorsky, assistant professor of radiation oncology at Penn State College of Medicine, the Penn State Cancer Institute research team accessed and analyzed over 12 million patient records involving 46 different cancer types between 2005 and 2015 in the National Cancer Database. The team found that only 11,576 (0.1%) of those patients were enrolled in clinical trials as their first course of therapy following diagnosis. The study results were published in the Journal of the National Comprehensive Cancer Network.
Dr. Niraj J. Gusani, professor of surgery at the College of Medicine and senior study author, reported that their findings—low enrollment among most people—is troubling as clinical trials may be beneficial for patients. Dr. Gusani noted, “Major advances in cancer treatment have been supported by clinical trials.” He continued, “By volunteering to participate in a trial, patients may help further the field of research and gain access to new treatments.”
Gender/Economic Status/Access Correlates to Cancer Research Participation
When the researchers study patients that get treated in clinical trials with similar patients not treated on trials, those that had trial access live longer. In fact, patients that could access clinical trials had a median survival of seven and half months longer than those that didn’t enroll in a clinical trial. The survival trend observed in cancer-focused clinical trials may not be comparable in the general population.
The overwhelming majority of those enrolling in clinical trials at first course of therapy tended to be white males with private insurance and access to academic medical centers; and importantly, no other chronic medical conditions. On this important point, Dr. Gusani communicated “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.”
Diversifying Clinical Trial Participation
A fundamental key for a thriving research imperative moving forward. As noted by Zaorsky, clinical trial infrastructure of clinical trial design and management must be fundamentally transformed before the required diversification can occur. For example, patients may not live close to where the clinical trial site is located, and even if the trial site is close, it may not involve the applicable type or stage of cancer.
With the emergence of patient-centered, decentralized clinical trial capability, it is now possible to design clinical trials with the patient in mind. The decentralized, patient-centric clinical trial design boom should be coming soon.
Finally, researchers note that clinical trials are carefully run, highly regulated, and monitored endeavors and that the public doesn’t necessarily understand this—more education is at hand to address the human “guinea pigs” perception among many patients. Get ready—the clinical research as a care option is coming to your community.
About Penn State Cancer Institute
The Penn State Cancer Institute is a cancer research center of the Penn State Milton S. Hershey Medical Center located in Hershey, PA. The institute offers clinical care, research, education, and community outreach services throughout central and eastern Pennsylvania. It serves approximately 3,000 inpatients and 22, 500 outpatients annually.
- Infusion therapy suites and private rooms for chemotherapy
- State-of-the-art radiation oncology suite for treatment options that refine tumor targeting and reduce treatment time, such as RapidArc radiotherapy
- A chemotherapy and infusion pharmacy staffed by clinical pharmacists and certified pharmacy technicians
- Outdoor healing garden, retreat, and other amenities
Penn Cancer State Institute represents the centerpiece of Penn State’s commitment to discoveries that will lead to the prevention, treatment, and cures for cancer.
Highmark Health Investment
Recently, the health system Highmark Health provided $25 million to support specialized cancer care and innovative research at Penn State Cancer Institute. The grant will support development of new cancer treatment drugs, clinical trials to test promising new therapies, and recruitment of leading cancer researchers in key disciplines.
Dr. Nicholas G. Zaorsky, assistant professor of radiation oncology at Penn State College of Medicine
Dr. Niraj J. Gusani, professor of surgery at the College of Medicine
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