Published Online: March 20, 2014
Jennifer L. Redmond, DrPH
Patients fear being a guinea pig or receiving a placebo, healthcare providers do not have time to keep up with all the clinical trial information or talk with patients in depth, conducting clinical trials are very expensive for healthcare systems and funding continues to decline for research. With all these barriers, it’s not surprising that clinical trial recruitment remains around 1.7% for adults.1
Many professionals throughout the country, including oncology nurses, surgeons, medical oncologists and researchers, have identified best practices and resources to help overcome many of these barriers, improve informed decision-making and increase clinical trial recruitment. Six professionals, actively involved in clinical trial education, navigation, review, recruitment and research, provided their perspectives on barriers and best practices:
• Oncology nurses
° Sue Childress, RN, MN, OCN, director of nursing at the Huntsman Cancer Institute, Salt Lake City, UT
° Cindy Davidson, APRN, clinical operations manager at the Huntsman Cancer Hospital in Salt Lake City, UT
° Joyce Schaffer, RN, MSN, AOCNS, clinical trials patient navigator with Scottsdale Healthcare in Scottsdale, AZ
° Timothy Mullett, MD, cardiothoracic surgeon at the University of Kentucky, Lexington, Kentucky and director of the Kentucky Clinical Trials Network
° Leigh Neumayer, MD, a general surgeon specializing in breast cancer at the Huntsman Cancer Institute, Salt Lake City, UT
° Margaret Byrne, PhD, associate professor at the University of Miami, Florida, focused on new tools related to informed decision making and clinical trials.
Barriers and best practices can be found at many places in the clinical trial system. These relate to the patient and family who may be fearful or confused by the trial, the healthcare professional who has no time to spend on clinical trials, and the healthcare system that struggles with handling the cost and inefficiencies of conducting clinical trials.
Patient and Family Barriers
Fear was touted 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 were an option, and if they did know, they may see participation as a last resort. Some also believe that a drug already approved by the US Food and Drug Administration (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. When conducting in-depth interviews with 45 minority patients, Byrne asked about whether they participated in a clinical trial. After providing information on their treatment experiences, many patients asked her if they had participated in a clinical trial.
Cost is another patient barrier. These costs include: travel, time off work, and cost of procedures, particularly if the patient is uninsured. 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. Depending upon the way a patient asks the question, they may receive a different response. As Schaffer said, “If a person calls an insurance company and asks if they will provide coverage for a clinical trial, they will say “no”, but if that person asks if they will cover the standard of care in a clinical trial, then they will say ‘yes’.”
There is also the impact of clinical trials on their families. Patients may not want to burden their families and will choose whatever is 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.
• Have everyone involved in the conversation, both the patient and close family members.
• Provide education on clinical trials so they know that it is a type of treatment rather than a placebo.
• Include all healthcare professionals in discussing clinical trials: nurses, social workers, primary care providers, surgeons, oncologists, and others.
• Have a dedicated research nurse to explain the clinical trials in depth.
• Utilize various types of media to educate patients regarding clinical trials including advertisements, Facebook, Twitter, and word of mouth.
• Develop relationships in the community by providing specific outreach and education to minority populations.
• Have a process for informed consent that includes the ability to address potential language barriers.
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
Healthcare Professional Barriers
Lack of time was the most common barrier noted for healthcare professionals. As Neumayer emphasized, “Time is number 1-10, particularly when we are asked to see so many patients, get them through more quickly and are pushed and pulled in so many directions. Number 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 the trials that might be appropriate for patients. Despite being aware of latest trials, in the midst of caring for patients, it becomes difficult to remember specific inclusion and exclusion criteria.
Lack of funding prevents institutions from hiring clinical trial coordinators who can provide guidance and chart reviews on identifying appropriate patients for clinical trials and communicating that information to the clinician.
There is no reimbursement to clinicians for clinical trials work, and since it takes a lot of time to discuss clinical trials with patients, there are negative financial implications for physicians. 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. Another fear, particularly from community oncologists, was that they would lose their patients if they recommended participation in a clinical trial.
To address the lack of time and coordination barriers, have a dedicated research nurse, clinical trials coordinator or clinical trials patient navigator who:
• Focuses on keeping up with the latest clinical 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.
• Talks with patients about clinical trials
Fostering communication and collaboration across researchers, nurses, physicians, and community oncologists increases knowledge of clinical trials and addresses 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—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
• Attend professional events and create opportunities to discuss clinical trials
• Require a percentage of continuing education credits focused on clinical trials
• Set goals, both individually and collectively, for clinical trial recruitment
• Celebrate successes and provide positive feedback
Healthcare Systems Barriers
Most of the healthcare system barriers focused on funding, coordination and insurance coverage. The funding barriers included the limited funding for clinical trial research, particularly from national research organizations and lack of health system-level resources. Even when there is funding, it 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.2
PDF is available on the last page.