The Cancer Trial Paradox – Too Few Patients to Some, Too Few Trials to Others

Applied Clinical Trials

David M. Kronfeld, the Head of Real World Data Innovation for Medidata, writes of Mercy Hospital in Joplin, Missouri, that despite seeing over 600 new cancer patients each year, it has historically had very limited access to clinical trials

Mercy Hospital in Joplin, Missouri, a former mining town, sees over 600 new cancer patients each year. That’s a lot for a town of just 50,000 people – about three times the national average – but Joplin is a medical hub for dozens of surrounding towns in Missouri, Kansas, Arkansas and Oklahoma. Despite the influx of patients, Mercy has historically had very limited access to clinical trials, which are often patients’ best hope for cutting-edge cancer treatments. Joplin was typically too small to attract drug companies or academics and too far from major research centers in surrounding larger cities for most patients to make the trip as often as needed.

Mercy oncologist Dr. Samir Dalia understands this firsthand. He often sent patients who seemed like good candidates for trials up to the University of Kansas Cancer Center, which has over 200 trials in progress. Once the clinician informed patients they need to be there twice a week to be on this clinical trial, many patients had to pass because they didn’t have the means or didn’t want to be away from their families.

Unfortunately, Joplin is not an anomaly. Community cancer treatment centers all around the country face the same problem – despite being the facilities where most cancer patients (around 80 percen1) get treatment. This means most cancer patients in the U.S. simply aren’t getting access to the best therapies available, and the sad irony is that clinical trials are in dire need of patients. As cancer research advances at a headlong pace, the number of clinical trials for oncology drugs have exploded, but the number of patients enrolling isn’t keeping up.

Not only is this frustrating for patients, but also for researchers and oncologists like Dr. Dalia, who want to provide the best therapies possible for their patients. This paradox has been an ongoing challenge for some time and the numbers continue to become more deafening.

The cumulative demand for patients in interventional oncology trials in the U.S. is 2.3 million patients2, which is just a fraction of the 15.1 million patients living with cancer in the U.S.3. Yet only 500,000 cancer patients are participating in trials , and many patients who are eligible for trials (up to 76 percent5) are never even asked to participate. In fact, there is such a dramatic mismatch between the number of patients sought by drug trials and the number of patients able to enroll in those trials today that 25 percent of cancer trials are withdrawn due to lack of enrollment . Low enrollment in trials is a waste of data and resources, as well as a huge loss for patients, as trial participation is strongly correlated with patient survival.

Patients who lose the most are those in small towns, far from academic research centers. Rural patients travel on average over 25 miles to get to trials and have lower rates of survival than their metropolitan counterparts, simply because of a lack of access to care 7,8 .

What lies at the root of this problem of access? It’s not just travel time for patients, oversight from the researchers or the growing volume of oncology trials. One challenge is that community hospitals would only be able to offer a small fraction of the patients needed for a large trial, which creates the need for multiple community hospitals to participate. This can present a regulatory burden for research efforts, as evaluating the quality of data provided by numerous smaller oncology centers can become an obstacle and tedious task.

Additionally, with the growing popularity of immunotherapy and personalized medicine, this narrows eligibility criteria even more. Personalized medicines account for 73 percent of all current oncology development9. To design personalized medicine requires identifying specific biomarkers. While trials that select patients based on biomarkers are three times more likely to receive FDA approval, finding a large enough pool of patients with a narrow set of biomarkers can be like finding a needle in a haystack.

The solution is clear – researchers must find efficient ways to tap smaller community treatment centers. Not only do these centers represent the majority of cancer patients, but they also tend to be much more diverse than populations of cancer patients that seek care at large academic centers.

One way to enhance the appeal of community treatment centers for clinical research is for these centers to join forces with larger companies, create a giant pool of patients and leverage technology.

Mercy Hospital is following suit by partnering with Guardian Research Network (GRN), a nonprofit network of more than 100 community hospitals that represents approximately 646,000 Oncology patients. This partnership provides Mercy with a trial matcher tool that compares patient data to eligibility criteria for individual clinical trials and forwards potentially eligible patients to study coordinators. With the help of technology, all of the trial sites have integrated inpatient and outpatient EHRs, with data transferred nightly into the system. Before the partnership with GRN, Mercy enrolled approximately a dozen patients in clinical trials with only one in 10 patients completing a trial. Today, two years later, enrollments are almost ten times that to 112 patients and eight out of 10 patient trial completion - a transformative and “phenomenal” experience according to Dr. Dalia at Mercy.

While obstacles may persist with limited access for patients and researchers, technology can help with this cancer clinical trial paradox. Partnering with companies that can identify specific biomarkers will bring eligible cancer patients in need of breakthrough therapies to the clinical trials that need them just as much.

References

1 “Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer: A Landscape Report” American Cancer Society Cancer Action Network, April 2018

2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2900458/

3 https://www.cancer.gov/about-cancer/understanding/statistics

4 American Society of Clinical Oncology Educational Book, “Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies”, Unger, 2016

5 “Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer: A Landscape Report” American Cancer Society Cancer Action Network, April 2018

6https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092479/

7 “At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials”, Oncologist, April 2018

8 “Identifying and Addressing Disparities in Survival Outcomes for Rural Patients with Cancer”, McCullough, JAMA Network, August 2018

9http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/The-Personalized-Medicine-Report1.pdf

David M. Kronfeld is the Head of Real World Data Innovation for Medidata.