Understanding and Addressing Barriers to Recruitment | Page 2
Published Online: March 20, 2014
Jennifer L. Redmond, DrPH
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
As Mullett explained, “Clinical trials are expensive, they disrupt the flow of clinical care, they require extra personnel and there are potential risks involved. 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 clinical trials.
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 several months.
The interviewees were hopeful that the Affordable Care Act would have a positive impact on reducing the insurance barrier.
These 6 healthcare professionals provided several recommendations to improve the healthcare system’s ability to recruit and conduct clinical trials. The following focused on addressing
the funding issues:
• 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 the 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 conduct trials that would be most cost effective, with responsible conduct and good clinical practice
There were also several recommendations related to coordination challenges:
• Encourage healthcare system leaders to begin the conversation about clinical trials in order to promote positive publicity and raise awareness among cancer patients and communities
• Invest in at least 1 person dedicated to being a clinical trials coordinator/expert within the healthcare organization
• Ensure that new technologies, such as electronic medical records, will support clinical trials efforts
• Combine practices to create bigger networks that would support clinical trials
• Include 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 priority consistently recommended by all 6 healthcare professionals included having a dedicated clinical trials person. As Byrne said, “There is agreement that it is important to have one person dedicated to being a clinical trials expert—a research nurse—where all she does is
talk with patients about clinical trials, knows what trials are available and coordinates the process.”
1. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720–2726. doi:10.1001/jama.291.22.2720.
2. Green L. One in five cancer trials end too early, but GU studies not more likely. http://www.onclive.com/conference-coverage/gu-2014/One-in-Five-Cancer-Trials-End-Too-Earlybut-GU-Studies-Not-More-Likely. Published January 28, 2014. Accessed February 6, 2014.
3. American Society of Clinical Oncology. Insurance coverage for clinical trial participants. http://www.asco.org/practice-research/insurance-coverage-clinical-trial-participants?et_cid=33233356&et_rid=619104094&linkid =http%3a%2f%2fwww.asco.org%2fpracticeresearch%2finsurance-coverage-clinical-trial-participants. Accessed February 4, 2014.