Cary Presant, MD
Clinical trials help community practices attract patients, inspire oncologists, and lower costs, but forming a program can be daunting to the uninitiated. The key to success: Enter the process as informed as possible, oncologists say.
“When we talk to other small practices, we tell them a major planning effort needs to be undertaken to start up clinical trials,” said Cary Presant, MD, an assistant clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope in West Covina, California. “It is a very time-consuming process, but it can be a rewarding process, too. We need to make sure the trials are safe, sustainable, and effective. If you do all that, it’s really exciting.”
Is your practice thinking of getting involved—or more involved—in clinical trials? Then read on to learn what you need to know in this how-to guide from Oncology Business Management.™ We compiled an overview of how these trials began and where they stand today, along with advice from 4 medical professionals on how to build a successful program.
Clinical Trials: Then and Now
In 1931, a milestone in achieving a controlled clinical trial in the United States took place surrounding an evaluation of the effectiveness of sanocrysin, a gold compound, as a tuberculosis treatment. Over the next several years, the National Cancer Institute (NCI) was founded and Congress passed a law forbidding pharmaceutical companies from marketing drugs unless they had been tested successfully in human trials.
The NCI began funding cooperative oncology groups in the 1950s to bolster clinical trial enrollment in the field. In the 1970s, amid breakthroughs in cancer research and a subsequent increase in NCI funding, the institute developed an outreach program that enabled community cancer centers to participate in trials run by NCI-affiliated cooperative groups.
For a long time, those groups ran the vast majority of clinical trials in the United States. “Community-based practices were leading accrual onto these types of trials,” John Powderly, an oncologist at Carolina BioOncology Institute in Huntersville, North Carolina, said. Over the past 15 years, however, the pendulum has swung: Private industry now develops and funds most clinical trials. By 2014, industry funded 6 times as many clinical trials as the National Institutes of Health did, up from 3.3 times as many in 2006. Meanwhile, the number of trials has risen to 18,400, up from 9321 in 2006.1
“The biopharmaceutical industry has begun to develop its own network of clinical sites, which range from private practices to hospitals, that have an interest and focus on participating in clinical research,” Powderly said. “I’ve been involved with clinical trials for about 20 years, and, I can certainly vouch for the fact that, over the past 15, the biopharmaceutical industry has grown at a rapid pace.” In an August 2017 report, Grand View Research forecast a rising domestic and global market for clinical trials research, stating that US clinical spending measured $18.3 billion in 2015, up from $17.4 billion the year before.2
For many practices, including Carolina BioOncology, that spending represents an important source of revenue.
Patients who want to participate in trials and seek out-of-state options take their medical dollars with them, to the detriment of local providers. An expansion of local cancer clinical trial options within the state of Kansas led to an estimated increase of $3.4 million in local medical spending, based on 19 patients who, as a result of the program, participated in clinical trials within Kansas rather than going out of state for care.3
Higher spending on development of costly new oncolytics has created opportunities for community clinics to participate in clinical trials, and personalized medicine, targeted therapies, genetic sequencing, and immunotherapy have been introduced into modern practice.
Immunotherapy is enormously popular with patients right now—many ask to participate in clinical trials because they’ve read about success with this class of treatment, according to Powderly and James Hamrick, an Atlanta, Georgia, oncologist affiliated with Flatiron Health. Combination immunotherapy trials have generated even more excitement, Hamrick said.
The way cancer treatments are developed also has changed over in recent years. In the 20th century, researchers primarily focused on amassing a body of knowledge, designing therapies slowly in accord with the flow of new information and major discoveries. That laid the foundation for 21st-century researchers to engineer therapies themselves, flooding the market with drugs and generating even more clinical trials, Powderly said: “All the new drugs of the past 15 years were not discovered, they were engineered. That’s brought with it an avalanche of new drugs.”