Financial burden is a significant barrier to cancer clinical trials, with both physicians and patients needing assurance that trial-associated costs will be covered. Community oncology practices can offer trials only if funding is sufficient to support them. Patients can agree to enroll only if third-party payers reimburse for the costs of care within the trial. Thus, alleviating the burden of costs is critical to enhancing overall participation in clinical trials in the community setting. The 12 practices that received a 2006 ASCO Clinical Trial Participation Award (CTPA) have gained success in clinical trials by devising ways to fund their research.
“It costs money to do clinical research,” says Anthony Greco, MD, of Tennessee Oncology (Nashville, Tennessee), one of the CTPA recipients. “We want to participate in [National Cancer Institute (NCI; Bethesda, Maryland)] trials, but we don't get enough compensation to participate.” Tennessee Oncology developed a unique approach to address the problem of inadequate funding. The practice first created the Minnie Pearl Cancer Research Network (Nashville, Tennessee), a national private cancer research cooperative group of affiliated private oncology practices, which then established the Minnie Pearl Cancer Foundation. “Money from the foundation helps defray some of the cost of research,” says Greco, explaining that a portion of the money from the foundation is targeted to trials conducted within the Minnie Pearl Cancer Research Network. In 2004, the network invested in a separate business, the Sarah Cannon Research Institute (Nashville, Tennessee). “This institute employs 125 full-time individuals and provides all the support for Tennessee Oncology to perform higher-quality clinical research,” says Greco. The practice offers no NCI-sponsored (cooperative group) trials, and most of the trials are investigator initiated.
Other CTPA recipients have also developed specific mechanisms to meet the financial challenges of clinical trial research. For example, the Marshfield Clinic collaborates with the Marshfield Clinic Research Foundation (both in Marshfield, Wisconsin) and affiliated hospitals to raise money for clinical research. The foundation, established in 1959, provides support for trials in a variety of disease settings, but cancer trials are predominant. This support enabled the practice to offer primarily cooperative group trials. In 2005, nearly 90% of its phase II and III trials were cooperative group trials.
After encountering financial loss with clinical trials several years ago, Michiana Hematology-Oncology, PC (South Bend, Indiana), petitioned local hospitals to organize the Northern Indiana Cancer Research Consortium (NICRC; South Bend, Indiana) in 1999. Composed of six hospital systems (including physicians, research nurses, and supporting staff), the NICRC provides organizational structure and financial support for conducting clinical research. The founding hospitals of the NICRC no longer contribute money. “Keeping the budget in the black [is a challenge],” says Robin Zon, MD, of Michiana. “Our program administrator continually reviews the budget and accrual patterns and, if necessary, prioritizes pharmaceutical studies.”
The NICRC also joined the Community Clinical Oncology Program (CCOP) in 2000 as another way to further broaden its participation in NCI-sponsored trials. Practices within a CCOP have access to nearly every major cancer clinical trial in the country, and CCOP members are required to offer NCI-sponsored trials in prevention, control, and treatment. CCOP funding is directly tied to cancer control credits, providing financial incentive for practices to enhance accrual to prevention and control trials.
Beth LaVasseur, Oncology Research Manager at St Joseph Mercy Hospital (Ann Arbor, Michigan), notes another benefit of belonging to a CCOP: “Once our practice obtained the CCOP grant, the relationships developed by building our reputation as a high-quality research practice allowed us access to pharmaceutical trials.” As do most of the award-winning practices, St Joseph offers a mix of industry and cooperative group trials. “We selectively participate in pharmaceutical trials to meet the needs of our patients when trials are not available for particular patient populations through NCI,” says LaVasseur. “The pharmaceutical trial revenue helps to support the underfunded infrastructure necessary to maintain our high-quality research program.”
Most of the CTPA recipients offer a mixture of industry-sponsored and cooperative group trials, with a range in the ratios of the two types. In 2005, approximately 28% of the phase II and phase III trials offered by St Joseph were sponsored by industry. In contrast, 60% of the phase III trials in which the Warren Cancer Research Foundation (Tulsa, Oklahoma) participated were sponsored by industry. “By balancing federally funded studies with industry studies, the organization's financial needs are balanced with providing the broadest range of studies to patients,” says James Lockhart, MD, a physician in the foundation.
The CTPA recipients have also addressed the barrier of appropriate patient reimbursement for the cost of routine care as part of a clinical trial, which has left some patients unable to participate in a clinical trial. Insurance denials and changes in Medicare reimbursement led the Wichita CCOP (Wichita, Kansas) to verify insurance reimbursement issues with the business office before opening a trial. “If it's likely that patients will not receive reimbursement, we may not open a trial or we will raise the issue with a study sponsor to find a means of implementing a trial locally,” says Marge Good, RNT, BSN, MPH, OCN, Manager of the Wichita CCOP. “We work very closely with business/insurance staff, maintaining open communication with the hope of preventing reimbursement issues for patients registered to trials.”
Currently, 23 states have laws or special agreements regarding reimbursement for cancer clinical trials (see table “Clinical Trials Covered in State Laws and Cooperative Agreements” online at www.jopasco.org). Wisconsin is the state to most recently adopt legislation that mandates reimbursement for patient-care costs in a clinical trial, and two CTPA recipients played primary roles in getting the law passed. Both Marshfield Clinic and Green Bay Oncology (Green Bay, Wisconsin) lobbied extensively in favor of Bill 617, and physicians in both practices are quick to acknowledge the leadership of the University of Wisconsin-Madison. “It's difficult as a single person to bring about such a change,” says Thomas Saphner, MD, of Green Bay Oncology. “We fell into rank behind a good leader, and I think a good state university system is key for such an effort.” The bill was signed into law on March 24, 2006, and became effective on November 1, 2006.
Marshfield Clinic conducted a Web search to collect data on insurance coverage for clinical trials in various states, and Tarit Banerjee, MD, of the clinic, wrote a resolution for the Wisconsin State Medical Society (Madison, Wisconsin). “Over the course of months, we collected data regarding the number of insurance denials we received, the number and type of clinical trials we have open, and the number of enrollees, and we shared this information with our state representatives in support of the bill,” says Banerjee.
Saphner notes, “Before this bill, if you offered a patient a trial and they called his or her insurance company and did not get complete assurance, the patient went into total fear. Now, we can tell Medicaid patients that coverage is guaranteed, and we can tell anybody who has routine health insurance within Wisconsin that costs are covered.” He adds that passage of the bill led to a “banner year for accrual.”