Enrolling patients into clinical trials in the community setting is critical to the advancement of medical innovation. Offering clinical trials to patients is also important to the success of a community-based cancer service. Most importantly, according to the Institute of Medicine, "Therapies offered through clinical trials should ideally be considered the preferred treatment choice for physicians and patients."
Community cancer centers and oncology networks can and must bolster their clinical research programs. A strong community-based cancer research program can accelerate cancer research, strengthen the cancer center and improve patient care.
Accelerating Cancer Research
"Precision medicine," or matching treatment with the unique medical and molecular characteristics of a patient and consistently applying evidence-based protocols, holds promise for dramatically improving cancer care. However, defining and targeting these treatments requires more clinical trial arms, and those trials require screening vast numbers of cancer patients to find those with specific requirements. Community cancer centers must play a pivotal role if these studies are to be successful and the discoveries translated into practice.
There are more than 1,100 community cancer programs and oncology networks conducting clinical trials and fewer than 250 academic and National Cancer Institute-designated cancer research centers. Eighty-five percent of cancer patients are diagnosed and receive initial treatment in community medical centers, yet more than 50 percent of the patients now in clinical trials are receiving their care at academic or NCI-designated cancer research centers. Not only is the patient population participating in these trials skewed — the subjects differ from the majority receiving treatment — but the physicians most likely to prescribe and deliver new care protocols are not involved in their development.
The clinical trials enterprise is failing us. About one-third of Phase III trials close with insufficient patient accrual — the accumulation of patients for a clinical trial — to meet expectations. Participation by adults in cancer clinical trials is remarkably low: less than 5 percent (though the best performers accrue patients at four to five times that rate). Even worse, it takes nearly 17 years for a treatment innovation to go from bench to the bedside. Better participation in clinical trials in the community not only will accelerate precision medicine but also will improve patient care by offering innovative medical treatments close to home.
Strengthening the Cancer Center
An effective clinical trials program also enhances a community cancer center. Patients are increasingly engaged in their own care, and their knowledge and expectations about treatment options are growing. Fifty-eight percent of Americans believe clinical trials are of great value, and another 38 percent believe they are of some value. The Mayo Clinic found that 76 percent of patients expected their respective doctors to inform them about clinical trials. Offering leading-edge treatments through clinical trials enhances the reputation of the cancer center and helps to attract and retain patients and physicians.
A robust clinical research program is also part of a learning health care system — one that translates data about care and operations into clinical practice and health system change. The effective learning health care system integrates research into patient care rather than treats it as a separate process. This requires the type of rigorous and consistent process that is used in clinical trials.
Engaging physicians in clinical trials builds the foundation for a learning health care system. It also positions the organization to engage in other leading-edge activities such as comparative-effectiveness studies, cancer care delivery research and performance-based cancer care management arrangements. Community cancer centers and oncology networks can provide access to advanced treatment for patients and improve the performance of their organizations through participation in clinical trials.
Improving Patient Care
There is evidence that patients who participate in clinical trials achieve better outcomes. This may be a result of access to new treatments that are not otherwise available, the careful attention and additional care that is provided as part of the research protocol, or the engagement of the patient in the process. While clinical trials are not without risks to the patient, they can provide an important treatment option that every patient deserves the opportunity to consider.
Virtually every advance in cancer prevention, screening and treatment over the last 40 years can be traced directly to clinical trials. A community cancer center that conducts a clinical trial is not only improving outcomes for its own patients, it is helping cancer patients everywhere.
Requirements for Success
Over the past eight years, the Education Network to Advance Cancer Clinical Trials has focused on improving access to cancer trials. We have conducted research studies, developed training programs, provided technical assistance to both academic and community cancer research programs, and facilitated a breakthrough learning collaborative that developed and implemented best practices for accrual in the community setting. Through these experiences we have identified the top 10 requirements for a successful clinical trials program.
Vision and strategy. While research is part of an academic cancer center's basic mission, that is not usually the case for a community-based cancer center. Therefore, the rationale for participating in clinical trials must be clearly defined. It should build on and be built into the culture of the organization and have the understanding and buy-in from leaders, clinicians and staff. An explicit strategy that makes the clinical and business case for trials and defines the requirements and measures of success is also necessary.
Selectivity. The portfolio of trials available must match the population served. This includes not only the types of cancers, but also the inclusion and exclusion requirements for eligibility. Often an interested physician will pursue research, but community-based cancer centers must consider the importance and relevance of the trial's research questions to patients and the ability of the organization and patients to comply with protocol requirements such as testing and monitoring. Meeting enrollment targets and budget considerations also must be factors.
Rapid initiation. There is an inverse correlation between the time to open a trial and the total enrollment. Opening trials quickly is necessary to ensure the study question remains relevant and physicians remain interested. This necessity requires an effective institutional review board and efficient negotiating and contracting. The NCI, for example, has now established maximum and target approval timelines with a goal of drastically reducing delays and improving efficiency for the studies it sponsors. It also offers a central IRB and support to help streamline the process.
Prescreening. All new cancer patients should be prescreened for eligibility for clinical trials prior to the initial physician visit. Only about one-third of cancer centers have such a routine process in place. The ENACCT breakthrough collaborative demonstrated the impact of this step on enrollment. An efficient process can be triggered by pathology reports or patient schedules. Measuring and monitoring this information also can improve the accrual process.
Integration. Clinical trials should be an integral part of patient care. Every patient potentially eligible for a clinical trial should be offered participation as a treatment option. Patients also should be provided with the information and support needed to make an informed decision. Ideally, reasons for not pursuing further eligibility testing should be recorded and used to improve the accrual process.
Communication. How the clinical trial opportunity is communicated to the patient can have a tremendous effect on the decision to participate. Consent requirements are increasingly complex, and patient information and communication preferences vary.
There are proven tools and techniques that physicians and research staff should use to ensure that the patient is making a truly informed decision. Consideration needs to be given to cultural competency, literacy level and the form of communication. Comprehension also should be measured. Communication with physicians is also important. Disseminating information about available trials and the accrual process is necessary to gain their participation.
Support. Patients participating in a clinical trial may be required to undergo additional treatment, testing and monitoring when they're already taxed by the stress of having cancer and the demands of treatment. The organization needs to help these patients with a variety of emotional and practical issues such as insurance coverage, transportation and scheduling. Alumni of clinical trials are an underused resource: They can provide patients who are considering a clinical trial unique insight about what participating really entails.
Management. In addition to monitoring and reporting, successful programs must also manage and continually improve the accrual process. This commitment requires involving key clinicians and administrative leaders appropriately in decisions and collecting and analyzing data on processes and outcomes. Data studies might include, for example, the number of patients enrolled versus the target enrollment, the portfolio of clinical trials versus the patient population, statistics on prescreening and trial offers, compliance and retention data, and budget performance measures.
Training. ENACCT has identified nearly 150 activities involved in the cancer clinical trials accrual process that are critical to optimal and efficient patient enrollment. Clinicians and research staff need a wide range of competencies beyond traditional patient care; while there are a number of certifications available in clinical research, none specifically addresses the accrual process in a comprehensive way. Best practices and operating procedures need to be delineated and documented, and training programs need to be identified or developed to ensure those practices are implemented consistently and continuously improved.
Community outreach. Awareness and understanding of cancer clinical trials is low not only among patients, but also among many referring physicians. Cancer patient advocacy organizations and other community-based and minority-focused health groups can be ambassadors to introduce clinical trials and raise awareness and understanding. Community leaders can be trained to reach out to their constituencies with information about cancer clinical trials, and those who have participated in clinical trials can be trained as resources for others.
Many referring physicians have some of the same misconceptions about clinical trials as do patients, and the overwhelming majority of physicians do not mention clinical trials as a treatment option when referring a patient to an oncologist. Discussion in medical staff meetings and routine communications can involve the referring physician in clinical trials and bridge any gaps.
Benefits for Everyone
Most community cancer centers and oncology networks easily could double or triple their clinical trials enrollment rates with a careful assessment of their existing program and by implementing the best practices and lessons learned from higher performing sites. Whether because of the new Commission on Cancer accrual standards, a growth strategy or a commitment to cancer research, effectively accruing patients and integrating clinical trials into patient care will accelerate the development and adoption of new and innovative treatments, strengthen a community's cancer service and improve patient care.
Louis Pavia serves the Education Network to Advance Cancer Clinical Trials as chairman of the development committee. He has more than 30 years of experience developing growth and improvement strategies for hospitals and health systems.