Strategies for Improving Clinical Trial Enrollment

Although clinical trials are essential for evaluating novel therapies and determining the most effective treatment options for patients with cancer, participation in these trials remains low, especially among ethnic and racial minorities. At the 2019 American Society of Clinical Oncology Annual Meeting, Kessely Hong, PhD, MPA, Faculty Chair, MPA Programs, and Lecturer, Public Policy, Harvard Kennedy School, John F. Kennedy School of Government, Cambridge, MA, and Electra D. Paskett, PhD, Marion N. Rowley Professor of Cancer Research, Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, discussed strategies to enhance clinical trial enrollment and retention.

Addressing Risk-Estimation Errors

According to Dr Hong, risk-estimation errors and susceptibility to framing can influence a patient’s decision to participate in a clinical trial. For example, he or she may overestimate the risk for or severity of potential treatment-related adverse effects compared with other options. In addition, these patient risk-estimation errors may be exacerbated by a lack of trust or poor communication between clinicians and patients.

“Misestimating any probabilities of success or failure, overly focusing on negative outcomes, or not having a good understanding of the compliance burden might cause patients to choose one branch or the other in a way that might not be fully in line with the actual probabilities,” Dr Hong explained. “Several studies have shown that this is particularly likely to be the case when patients are minorities.”

Drawing on the work of psychol­ogists Amos Tversky and Daniel Kahneman, Dr Hong noted that prospect theory can help clinicians understand how patients evaluate their potential options based on their starting reference point. Using examples that span a wide array of contexts and decisions, this theory has demonstrated that people are more likely to behave in a risk-seeking manner when their decision is framed as an opportunity to avoid a certain loss (but with the risk of facing a greater loss) than when their decision is framed as an opportunity to increase a gain (but with the risk of no gain).

“In the case of advanced pancreatic cancer, for example, the standard of care is quite dismal and there is a very high risk for dying in a short time period,” she said. “Any clinical trial option that is proposed, even if it carries a risk for more imminent loss or worse side effects, is likely to be embraced because it offers a tiny sliver of hope of avoiding that certain loss.”

On the other hand, said Dr Hong, for diagnoses for which the standard of care is not as dire, whether that standard of care is presented as a positive option (where the patient may do better but also risks losing the benefit) or a negative option (where the patient could potentially avoid that loss by participating in a clinical trial) will make a very big difference in the patient’s decision-making. Consequently, there are several strategies to help clinicians and patients make more accurate risk assessments and better-­informed decisions.

“Clinicians need to be made aware of data showing that when offered the chance to participate in a clinical trial, minority patients actually have very similar rates of clinical trial accrual compared with nonminority patients,” said Dr Hong. “Clinicians should not assume the answer will be ‘no’ because minority patients are actually willing to participate in trials at similar rates as other patients if they’re just given the chance.”

The Role of Patient Navigation in Clinical Trial Participation

Patient navigation, which has been shown to be effective across the cancer care continuum, is another strategy for overcoming barriers to clinical trial participation. According to Dr Paskett, patient navigation can enhance communication between patients and clinicians regarding potential health benefits and risks as well as the nuances related to the burden of compliance.

“Patient navigation can address multiple barriers to clinical trial participation at multiple levels and deal with the unique barriers that every different patient has that comes into your clinic,” said Dr Paskett, who emphasized that navigators work for patients not clinicians.

“Navigators do not recommend care,” she continued. “Their goal is to identify and address any barrier that a specific patient has to receiving the care that’s recommended by the provider.”

As Dr Paskett explained, patient navigators speak to patients in a language that they understand and have demonstrated improved metrics with respect to clinical trials, knowledge, intention, and retention. In addition, navigation can easily be integrated into the clinical trial process. Nevertheless, adequate funding is required.

“More institutions need to realize the value and the return on investment for patient navigators and hire them,” Dr Paskett concluded. “Adding patient navigation as a reimbursable service would also be beneficial.”

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