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.
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.
Patient and Family ConcernsFear 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 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.
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.
Joyce Schaffer, MSN, RN, AOCNS
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.
Best PracticesEveryone 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.
The Moffitt Cancer Center has produced an 8-minute patient video to explain the process and help to reassure patients (http://goo.gl/lH57MN). 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.
Margaret Byrne, PhD
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 RoleLack of time was the most common barrier noted for healthcare professionals. As Neumayer emphasized, “Time is number one 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. 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 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 trials coordinators who can provide guidance and chart reviews to identify appropriate patients for clinical trials and communicate that information to the clinician. 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.
Timothy Mullett, MD
Best PracticesTo 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 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
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.
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.
Healthcare SystemsMost 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.
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).
Best PracticesAs 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.
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 Redmond, DrPH, is an assistant professor at the University of Kentucky, College of Public Health. In that role, she serves as a co-investigator 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.
- 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.
- American Society of Clinical Oncology. Insurance Coverage for Clinical Trial Participants. Available at: http://www.asco.org/practice-research/ insurance-coverage-clinical-trial-participants?et_cid=33233356&et_ri d=619104094&linkid=http%3a%2f%2fwww.asco.org%2fpracticeresearch% 2finsurance-coverage-clinical-trial-participants. Accessed February 4, 2014.