Tackling Patient Recruitment Challenges in Clinical Trials

Patients fear being a “guinea pig” or receiving a placebo, healthcare providers do not have time to keep up with all of the clinical trial information or talk with patients in depth, conducting clinical trials is very expensive for healthcare systems, and funding continues to decline for research. With all of these barriers, it is not surprising that only 3% of adult patients with cancer participate in clinical trials.¹

Obstacles can be found throughout the system, including the patient and family who may be fearful or confused by the trial, the healthcare professional with little time to spend on clinical trials, and a healthcare system struggling with the costs and inefficiencies of conducting them.

Increasing enrollment in clinical trials is a priority for stakeholders across the continuum of cancer research and treatment. Many professionals throughout the country, including oncology nurses, surgeons, medical oncologists, and researchers, have identified best practices and resources to help overcome many of the barriers, improve informed decision-making, and increase clinical trial recruitment.

Patient and Family Concerns

In this article, six experts actively involved in clinical trial education, navigation, recruitment, and research provide their perspectives on the barriers and share best practices for overcoming them.Fear was described as the greatest barrier for patients and families, particularly the fear of being a “guinea pig” or receiving a placebo rather than treatment. Patients may not know that clinical trials are an option for them, and if they do know, they may see participation as a last resort. Some also believe that a drug already approved by the FDA would be better than a drug that is not yet approved.

Clinical trials can be complicated and confusing. Some patients would rather just say “no” to participation because it is easier. Cost is another patient barrier. These costs include travel, time off work, and the cost of procedures, particularly if the patient is uninsured.

Joyce Schaffer, MSN, RN, AOCNS

Despite new protections that are part of the Affordable Care Act, insured patients may be concerned that there will be unexpected costs that are not covered by their insurance. Some patients have limited insurance plans with minimal out-of-network benefits, and many patients do not know the rights they have within their plans.

In fact, depending upon the way a patient asks the reimbursement question, they may receive a different response. As Joyce Schaffer, MSN, RN, AOCNS, explained, if a patient or family member calls an insurance company and asks whether coverage will be provided for a clinical trial, the insurer may say “no,” but if asked if insurance will cover the standard of care in a clinical trial, then the payer will say “yes.”

Best Practices

Clinical trials also impact the patient’s family. Patients may not want to burden their families and will choose treatment they believe will be easiest for their families, even if it may not be the best for them.Everyone agreed that communication and education were essential in overcoming the fear-based patient and family barriers to clinical trials. Some specific approaches, mostly focused on healthcare professionals’ involvement, included the following: Provide all the treatment options, including eligible clinical trials, to the patients and their families. Involve them in the decision-making, and engage everyone in the conversation. Recognize that all healthcare professionals have a role in recruitment, including oncologists, nurses, surgeons, social workers, and primary care providers. Educate patients so that they know that clinical trials offer a type of treatment rather than a placebo.

Margaret Byrne, PhD

The Moffitt Cancer Center has produced an 8-minute patient video to explain the process and help to reassure patients.

Margaret Byrne, PhD, said that she has developed web-based decision aids for clinical trials still in the research process. Once completed, these tools will be available for patients.

Deploy various types of media to educate patients regarding clinical trials, including advertisements, Facebook, Twitter, and word of mouth, and develop relationships in the community by providing specific outreach and education to minority populations.

Designate a dedicated research nurse to explain the clinical trial options in depth, and have a process for informed consent that includes the ability to address potential language barriers.

“It is important to provide one-on-one communication with the patient and family on all the treatment options. Spend the extra effort needed— however much time it may be—allowing the patients to have some control over their decisions,” said Cynthia Davidson, APRN.

Another point to emphasize, said Leigh A. Neumayer, MD, and one she explains to her patients: “Thank God for all the women who came before you who were altruistic and agreed to participate in these clinical trials, which has impacted your ability to have these treatment options.”

When addressing the cost concerns of the patients and families, the interviewees recommended the following:

• Connect patients to financial counselors or social workers to identify resources. Once they are off of a trial, treatment resources are often available by contacting the drug company directly.
• In partnership with private foundations, set up patient assistance programs in coordination with local hotels and businesses to help with travel expenses.
• With Institutional Review Board approval, provide reimbursement from the trial for some travel expenses, including food, lodging, and transportation.
• Write letters and advocate for patients to insurance companies.
• Encourage patient participation in the Health Insurance Exchange Marketplace.

The Clinician’s Role

Lack of time was the most common barrier noted for healthcare professionals. As Neumayer emphasized, “Time is No. 1 through 10, particularly when we are asked to see so many patients, get them through more quickly, and are pushed and pulled in so many directions. No. 11 is remembering, and 12 is identifying the appropriate patients.”

Related to time was a lack of knowledge and ability to keep up with all of the trials that might be appropriate for patients. Even when a clinician knows the latest trials, in the midst of caring for patients, it becomes difficult to remember specific enrollment criteria.

“There are so many different trials with varying inclusion and exclusion criteria, stage and age information that clinicians struggle keeping up with the latest,” noted Timothy Mullett, MD. We see lots of patients . . . we get through with their care and then think, oh, this would have been a good trial for patient A, B, or C.”

Lack of funding can prevent institutions from hiring clinical trial coordinators who can provide guidance and chart reviews to identify appropriate patients for clinical trials and communicate that information to the clinician.

Timothy Mullett, MD

Fear among healthcare professionals was mentioned several times during the discussions. One fear, particularly seen among nurses, was of the unknown impact of treatment and the concern that the patient might not receive the best treatment possible.

Best Practices

“When we initially started phase I trials, the nurses were concerned that patients may not receive the best treatment possible. After listening to their concerns and addressing them, now what I hear is that they are proud to work in a place that offers these trials. The patients don’t have to travel to Chicago or San Francisco,” noted Sue Childress, RN, MN, OCN. Davidson mentioned another fear, particularly of some community oncologists, that they would lose their patients if they recommended participation in a clinical trial.To address the lack of time and coordination barriers, practices should have a dedicated research nurse, clinical trials coordinator, or clinical trials patient navigator who:

• Focuses on keeping up with the latest trials
• Reviews the patients’ charts and types of cancers (prescreening)
• Identifies which patients would be eligible for particular trials
• Advises the physician to talk about certain clinical trials
• Coordinates the process and talks with patients about clinical trials.

Fostering communication and collaboration across researchers, nurses, physicians, and community oncologists will help to increase knowledge and awareness of clinical trials and address some of the fear and cost concerns. Some practical ways to encourage this collaboration include: Meet periodically with researchers, physicians, and community oncologists to share what clinical trials are available for patients. Create opportunities to listen to the concerns of specific healthcare professionals—nurses, social workers, community oncologists, and other physicians—and provide opportunities for discussion and ways to address their concerns. Involve as many healthcare professionals as possible in discussing clinical trials at every opportunity. Open trials in collaboration with community oncologists.

Develop communication pieces (newsletters, etc) on current clinical trials for nurses, community oncologists, and other physicians. Include a “pink sheet” or electronic reminder in every chart where the clinical trials coordinator/ navigator can put the patient’s name and tumor characteristics. Provide a space for the physician to make notes on the result of the discussion of the trial.

Affordable Care Act

The law, effective for health plans newly issued or renewed after January 1, 2014, prohibits health plans or insurance issuers from:

• Denying participation of beneficiaries in clinical trials
• Denying or limiting coverage of routine patient care costs, subject to the plan’s out-ofnetwork coverage policy
• Discriminating against the individual on the basis of participation in a trial²

Potential impact on clinical trials:

• More patients will have insurance so they can be reassured that they won’t have any additional bills whether they are participating in a clinical trial or not.
• Cancer patients under 26 years are able to stay on their parents’ insurance plan and have coverage for standard treatments.
• Patients should continue to have insurance after their cancer and/or participation in the clinical trials because they cannot be discriminated against based on preexisting conditions.
• The reimbursement structure will change— which may or may not be beneficial—for clinical trials.
• Interpretation and full implementation of the Affordable Care Act is still unknown.

Healthcare Systems

Set goals, both individually and collectively, for clinical trial recruitment. Consider requiring that a percentage of continuing education credits be focused on clinical trials as a way to help meet targets. Celebrate successes and provide positive feedback.Most of the healthcare system barriers discussed focused on funding, coordination, and insurance coverage. The funding barriers included the limited funding for clinical trial research, particularly from national research organizations, and a lack of health system—level resources. Even when there is funding, this funding may be insufficient to be able to design the trial that would best test the treatment modalities. Funding is also targeted to particular types of cancers that may be disproportional to the disease burden. Many trials remain open and recruit a minimum number of patients, which can be extremely expensive.

“Clinical trials are expensive, they disrupt the follow of clinical care, they require extra personnel, and there are potential risks involved,” Mullett explained. “Those in the ivory tower want us to take care of patients efficiently, and bill for it . . . there is just no way to justify the costs, so there has to be a commitment from the enterprise that they are willing to take a loss on it.”

Connected to the funding barrier is the lack of coordination, as well as the requirement of significant documentation. There is often no easy way to find out which patients are eligible for what trials. If the facility or system has not funded a clinical trials coordinator, and there is minimal infrastructure provided, then it is difficult to get all the healthcare professionals working together on recruitment.

There were varying responses related to the insurance component. Some of the interviewees had frequent challenges with insurance plans not covering care outside of their system or facility even though the system or facility didn’t have the treatment options available to the patient. Others found that those with insurance had adequate coverage for standard of care.

Best Practices

They all had concerns about the uninsured, and although some of them were often able to eventually find resources to support their care, uninsured patients sometimes delayed their treatment for several months. The interviewees were hopeful that the Affordable Care Act would have a positive impact on reducing insurance barriers (Sidebar).As Childress emphasized, the clinical trial awareness and recruitment process really needs to be “hardwired” into the organization. Funding is critical, and these experts offered the following recommendations:

• Work together as an organization to advocate to legislative bodies for additional funding
• Collaborate with cancer center fundraising efforts to support clinical trials
• Identify private foundations interested in supporting clinical trials
• Support many different types of clinical trials from industry-supported, which often have adequate funding, to cooperative and investigator- initiated ones
• Recognize their importance and support clinical trials with personnel, office space, and resources to achieve clinical trial goals
• Consider the clinician support and system capacity prior to conducting trials. Only do the trials that would be most cost effective with responsible conduct and good clinical practice.

As Neumayer emphasizes, “We should not open the trial, unless everyone who is seeing these patients is enthusiastic about the trial. We used to have a mindset that you needed a trial for every patient who walks through the door.” Now, she said, the ones that do open are able to recruit patients.

Recommendations related to coordination challenges include encouraging the healthcare system leaders to begin the conversation about clinical trials in order to promote positive publicity and raise awareness among cancer patients and communities; ensuring that new technologies, such as electronic medical records, will support clinical trials efforts; combining practices to create bigger networks that would support clinical trials; and devising clinical trial participation metrics into dashboards and other measures of performance. Although it may take time for a healthcare organization to implement these best practices, a strategy consistently recommended by all six experts was the designation of a dedicated clinical trials coordinator. “There is agreement that it is important to have one person dedicated to being a clinical trials expert—a research nurse—where all he or she does is talk with patients about clinical trials, knows what trials are available, and coordinates the process,” Byrne emphasized.

Whatever approaches practitioners employ to encourage more patients to enroll in clinical trials, the goalpost is the same—helping patients. Schaffer said she has many patients call her and say, “ ‘I’m driving home from my doctor’s office and they just told me that there is nothing they can do for me.’ I’m able to give hope.”

Jennifer L. Redmond, DrPH, is an assistant professor at the University of Kentucky, College of Public Health. In that role, she serves as a coinvestigator for the Kentucky Cancer Consortium, Kentucky’s comprehensive cancer control coalition, which catalyzes implementation of a statewide Cancer Action Plan focused on prevention, early detection, treatment, care, and quality of life.

References

1. Institute of Medicine Forum on Drug Discovery, Development, and Translation. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: National Academies Press; 2010.
2. American Society of Clinical Oncology. Insurance Coverage for Clinical Trial Participants. Available at: http://www.asco.org/practice-research/insurancecoverage- clinical-trial-participants?et_cid=33233356&et_ rid=619104094&linkid=http%3a%2f%2fwww.asco. org%2fpractice-research%2finsurance-coverage-clinical-trialparticipants. Accessed February 4, 2014.