Evidence-Based Oncology

Understanding and Addressing Barriers to Recruitment | Page 2

Published Online: March 20, 2014
Jennifer L. Redmond, DrPH
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.

Best practices

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.”

References

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.