Tackling Patient Recruitment Challenges in Clinical Trials

Jennifer L. Redmond, DrPH
Published Online: Wednesday, March 26, 2014
Consulting 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.

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 Concerns

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

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.”

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 Practices

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

Margaret Byrne, PhD

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.

Online CME Activities
Free CME from PER
Community Practice Connections: 13th Annual International Congress on the Future of Breast Cancer®
Highlights From the 13th Annual International Congress on the Future of Breast Cancer®
Pancreatic Cancer: Novel and Emerging Approaches to Early Detection and Treatment
Oncology Best Practice: Challenges in Treating Chronic Lymphocytic Leukemia – The Older Patient and Comorbid Conditions
More Reading
$auto_registration$