Finding the On-Ramp to Clinical Trial Offerings

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.”

Clinical Trials: Then and Now

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.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.”

As a result, companies and industry groups can’t sign patients up for clinical trials fast enough, Hamrick said. Trials have become widespread, commonplace, and carefully managed at community practices and research hospitals alike—though raising levels of patient participation continues to require a lot of work.

“It’s a highly regulated field that’s getting more and more complicated,” Hamrick said. “And in its current state, it’s a very inefficient process that can be very disruptive to doctors’ workflow.” Indeed, among the reasons oncologoists commonly cite for not enrolling patients in trials is a shortage of time and resources to build awareness of trials and share that information with patients. A 2016 survey from Memorial Sloan Kettering Cancer Center called lack of participation in clinical trials the Achilles’ heel of the cancer community, noting research showing that just 4% of patients with cancer enroll in clinical trials each year. The survey polled 600 physicians, and—although clinical trials are available to patients during the earliest phases of treatment—56% of oncologists said they considered clinical trials only late in treatment, with 28% saying they consider them a treatment “of last resort.” Only one-third said they discuss trials with their patients at the start of treatment.⁴

1. Don’t go it alone.

It’s important to minimize the administrative burden of clinical trials and keep the process fun, Hamrick and Presant said. In fact, Presant noted, the programs’ burnout-fighting potential offers a major incentive for a practice to run clinical trials. Along with Powderly, Hamrick, and Melissa Pool, BSN, RN, clinical research director of the Center for Cancer and Blood Disorders in Fort Worth, Texas, Presant shared tips on how to ensure that participation is exciting, not exhausting, for community practices.Linking up with an academic research center or cooperative group allows a small practice to test the waters before establishing its own research staff. Before Presant’s practice, Wilshire Oncology, merged with City of Hope, it partnered with the research center on clinical trials.

2. Start small.

Joining an oncology network such as the Community Oncology Alliance, ASCO, or a state oncology society can be very helpful, as well, the oncologists said. They recommended making access to shared wisdom a primary goal, even if it’s just by talking with other physicians. “If you’re a small practice that’s just starting out, you should try to connect with other practices that are doing research. There are a lot of tricks of the trade that can be really helpful,” Hamrick said. “Leveraging experience is really important.”Choose a trial that’s right for your practice. One that requires around-the-clock pharmacogenetic blood testing, for example, would not be a good fit for a community practice. “There are phase I clinical trials we don’t participate in because they require too many samples or are otherwise too cumbersome for us to do,” Presant said.

3. Build relationships with pharmaceutical companies.

Pool recommended joining a smaller, less complex study furnished by a cooperative group. “Those are easier to be a part of,” she said. “[Community practices] might start small there, and after they get some experience with conducting those trials, they might be able to branch out.”It’s not easy to forge a relationship with pharmaceutical companies, which rely on third parties to set up trials, but doing so can yield huge rewards, oncologists say. Otherwise daunting tasks, such as asking a company to pay for any required clinical testing, become easier if you already have have a rapport.

Pool recommends building the relationship while participating in a trial through a cooperative group. Her practice joined a site-management organization to help connect it with pharmaceutical companies. “The research sites use the SMO to get access to clinical trials, and the pharmaceutical companies use the SMOs to get access to sites,” Pool said. Most pharmaceutical companies have a medical science liaison—the point person for clinical trials.

4. Build a research staff.

Working with practitioners who have experience with pharmaceutical companies offers another way to gain access to a practice-company relationship. Many oncologists participate in clinical trials during their medical training, and many administrators deal with pharmaceutical companies during day-to-day business.Oncologists recommend that practices delegate tasks associated with clinical trial participation to a research staff, which might consist of just 1 person or as many as 20—or even more. Building that staff takes time but is “really crucial,” Hamrick said.

5. Stay on top of paperwork to be prepared for audits.

If the research staff consists of a “single champion doctor,” Powderly said, that doctor must take a strong, focused interest in clinical trials. “That focused interest cannot be a hobby—you cannot just dabble in it,” he said. “To get access to clinical trials, the oncologist has to make a personal commitment that this is going to be a strong focus of their practice.”“With any clinical trial, you can expect there will be an audit,” Presant said. During an FDA audit, oncologists hand over all their records associated with a clinical trial. Those records should be diligently kept, particularly in the areas of toxicities and dose adjustments, to keep the practice in good standing with the FDA, Presant said.

6. Take advantage of technology.

Divvy up recordkeeping tasks to reduce the threat of burnout. Hamrick recommended recruiting research staffers who have experience within a regulatory environment.Using the right software the right way can simplify the process of running a clinical trial. Hamrick’s practice relies on OncoTrials to review patients’ eligibility. “It’s a cloud-based web portal that’s linked to OncoEMR. We load all of the trials into the system from ClinicalTrials.gov, a repository of clinical trials in the United States,” Hamrick said. “The software helps match patients with the trials that are open.”

Ensure that participants’ x-ray results are rapidly forwarded to the electronic health record system so clinical trial monitors can see them, Presant said.

References

1. Ehrhardt S, Appel LJ, Meinert CL. Trends in National Institutes of Health funding for clinical trials registered in clinicaltrials.gov. JAMA. 2015;314(23):2566-2567. doi: 10.1001/jama.2015.12206.
2. Grand View Research. Clinical market analysis by phase (phase I/II/III/IV), by study design (interventional, observational, expanded access), by indication (autoimmune, pain management, oncology, CNS condition, diabetes, obesity), and segment forecasts, 2014-2025. www.grandviewresearch.com/industry-analysis/global-clinical-trials-market. Published 2017. Accessed October 4, 2017.
3. Gafford, JA, Gurley-Calvez T, Krebill H, et al. Expanding local cancer clinical trial options: analysis of the economic impact of the Midwest Cancer Alliance in Kansas. Acad Med. 2017;92(9):1274-1279. doi: 10.1097/ACM.0000000000001612.
4. Despite pressing need, survey finds most Americans unlikely to enroll in clinical trials [news release]. New York, NY: Memorial Sloan Kettering Cancer Center Pressroom; May 23, 2016. www.mskcc.org/press-releases/despite-pressing-need-survey-finds-most-americans-unlikely-enroll-clinical-trials. Accessed October 4, 2017.