On Trial: Considering Clinical Oncology Trials as a First Line of Offense
Once a “court of last resort,” too many patients and physicians still consider clinical trials the last step once all other options are exhausted. While that might have been true once upon a time, physician researchers involved in Nashville’s robust clinical trials programs said the opportunity to participate in a trial should certainly be considered a patient’s first line of offense.
 
“This should really be the first option you think about,” offered Skip Burris, MD, chief medical officer for Sarah Cannon Research Institute. A worldwide leader in clinical trials, SCRI accrued a bit over 2,500 patients in oncology trials in 2009 — 515 in Phase 1 trials and a little more than 1,000 each in Phase 2 and Phase 3. Burris added the number jumps to nearly 4,000 patients when non-oncology trials are included in the mix.
 
“A clinical trial is going to afford them many advantages,” he continued of patient benefits. He noted that in addition to access to the newest therapies, the very nature of a clinical trial ensures an emphasis on education, additional sets of hands and eyes working with the patient and a more integrated overall care plan.
 
“In the United States, you need to look at a clinical trial as you’re getting the best standard of care … plus something extra,” Burris said.
 
Added Ravi S. Chari, MD, chief medical officer for Centennial Medical Center and the interim director of the Sarah Cannon Cancer Center, “I think the hallmark of an advanced cancer center is to be able to offer clinical trials.” Powered by SCRI, he continued, patients are able to access a full spectrum of trials and therapies. “It forces all of our clinicians to be aware of the latest developments. It elevates everyone’s performance. It complements all the activities we do and creates a better care offering for patients.”
 
Jordan Berlin, MD, director of Phase 1 Research Initiatives for Vanderbilt-Ingram Cancer Center (VICC), concurred with the sentiment. “Clinical trials are really not end-of-care trials,” he stressed. “There are clinical trials designed for pretty much every stage of patient care in oncology. In the early stages, it usually involves adding something to the standard of care.” After all, he pointed out, “If the standard of care was so good, we’d be done.”
 
Unfortunately, Berlin noted, there is a common myth among patients … and even some physicians … that a placebo arm of a trial means a patient runs the risk of receiving no effective treatment. That, he said, just isn’t the case. In a typical setup, Berlin said, a patient would either receive the standard of care plus a new drug or drug combination or would receive the standard of care and a placebo. Bottom line, though, the patient would get at least what is considered the best care currently available.
 
For Berlin, who is also the clinical director of GI Oncology and medical director of the Clinical Trials Shared Resource at VICC, the number of early stage trials being launched nationwide is a testament to how far the field of oncology has come and a major focal point for Vanderbilt. “The reason we’re putting a huge emphasis on Phase 1 is we have the good fortune that our treatments are better than they were so more people reach the end of known therapeutic treatments,” he said, adding that once a patient has worked through the evidence-based therapies currently available then a stand alone experimental drug versus placebo might come into play.
 
VICC is one of the few institutions in the nation that has three SPORE — Specialized Program of Research Excellence — grants from the National Cancer Institute. Researchers are focusing attention on breast, lung and gastrointestinal … specifically colon … cancers. “In recent years, we’ve risen to the seventh highest NIH-funded cancer center in the country, and that’s in spite of being small, relatively speaking,” said Berlin.
 
There is a strong emphasis on unraveling cancer at a molecular level and excellent animal labs for the earliest stages of discovery. Additionally, the integrated medical informatics department is able to analyze the large number of data points flowing in from all phases of trials.
 
SCRI and Sarah Cannon Cancer Center are equally committed to unlocking the mysteries of cancer and building the body of oncology knowledge. However, they have opted to take a bit different route.
 
“Our focus is on patient care,” said Burris. To that end, SCRI typically works with pharmaceutical partners on launching new therapies. “One of the things we compliment ourselves on is our speed of getting trials up and running and information accrued,” he continued.
 
Another distinguishing characteristic of the program is the network structure. Chari explained, “The ability to partner with SCRI gives Sarah Cannon Cancer Center unprecedented ability to offer access to clinical trials to the community.”
 
Partnering with community practices … both large and small … accomplishes several goals. It provides more data to analyze and allows for faster accrual of data, which moves the science forward at an accelerated pace. “It keeps us moving to the next question … the next answer,” said Burris.
 
Chari noted another benefit is that these partnerships bring “the best opportunity to receive cutting-edge treatment and access to the latest innovations” close to home where patients have support systems in place. Equally important, he continued, the coordinated care model extends beyond the patient to include personal caregivers. “We also partner with the Minnie Pearl Cancer Foundation to provide support and education for families.”
 
Whether patients receive care in Nashville or within their home community, Chari said the family practitioner and other members of the care team receive direct communication from Sarah Cannon Cancer Center practitioners. Added Burris, “Keeping the primary care physician involved is critical.”
 
No matter which route is taken to get patients into clinical trials, the net result is that oncologists are creating care plans that are continually evolving and becoming more and more personalized.
 
“We’re going to get more and more sub-specialized,” observed Berlin. “We’re trying to target the treatments to the people who will best benefit from them based on either the patient’s characteristics or the tumor characteristic.”
 
For example, Burris noted, breast cancer is actually many different diseases under one general diagnosis. “Right now in our breast cancer menu there are more than 20 studies. We don’t try to fit every patient into one study.”
 
In addition to the trials offered by Sarah Cannon and VICC, there are research programs throughout Middle Tennessee including Saint Thomas Health System and a growing program at Cookeville Regional Medical Center. “Most every oncologist in Nashville is engaged in research,” Berlin noted.
 
The reason is simple, Chari summed up. “The real advancements in cancer care have come only through the trial mechanism so we’re big proponents of clinical trial first.”