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Creating positive experiences and other patient-focused strategies for sponsors to consider when planning and executing cancer studies
Patient engagement is critical to the success of oncology clinical trials, many of which have endpoints that require study participants to be followed for many years to evaluate side effects and long-term survival data. And yet, sponsors often postpone careful consideration of strategies for patient engagement and retention until after the treatment phase of their studies. Consequently, patients may be lost to follow-up, or protocol amendments may be required to increase retention, adding cost, delaying timelines, or even adversely impacting data quality. Another risk frequently overlooked is the potential for patients to perceive study participation as a negative experience, which can make recruitment for future clinical trials even more challenging.
Integrating patient perspectives
Patient engagement is valuable not only for gathering protocol-specific insights, but also for informing the overall recruitment and retention strategy. Combining data with a deep understanding of the patient perspective is crucial in oncology studies, since each patient has a unique experience with their disease and their own approach to coping with their condition, both physically and psychologically. Understanding these nuances makes it easier for sponsors to design clinical trials that will be accepted by potential patients as a viable treatment option.
Sponsors should consider engaging with not just patients, but also family members, caregivers, patient advocates, and advocacy groups. Useful insights to gather include disease impact, current treatment, unmet needs, barriers to adherence, and points in the care journey where patients are most likely to consider investigative treatments.
Developing patient-focused protocols
Early-phase oncology trials often involve weekly visits, serial blood draws, and multiple biopsies, all of which add burden beyond the standard of care. When developing trial protocols, sponsors may benefit from scrutinizing the proposed number, frequency, and location of assessments, with the goal of reducing burden while preserving patient safety and data quality.
It is vital for biopharma sponsors to consider the many facets of burden, whether it is interference with daily life, invasiveness of procedures, or impact on physical, emotional, or financial well-being. For instance, many oncology studies include tumor assessments via imaging. Coverage of such imaging will depend on the tumor indication, and the patient’s insurance plan may not support the frequency proposed in the study protocol. In such cases, sponsors may want to consider requiring less frequent assessments or providing upfront reimbursement for out-of-pocket imaging costs.
For assessments deemed critical, sponsors may benefit from identifying those which can be performed offsite and incorporating options for remote participation. For example, if frequent blood draws are required, contracting with a local lab, mobile research nursing provider, or home health vendor would allow patients to stay at or close to home, rather than traveling to the primary research site. A growing number of assessments can be performed remotely via telemedicine and offsite nursing, including:
In addition, there has been a profusion of wearables with sensors that continuously collect data that can be transmitted and integrated directly into the electronic data capture system, reducing burden on both patients and sites.
Increasingly, regulatory agencies are seeking clinical trial diversity to promote the development of therapies that are effective across populations. Given that barriers to clinical participation among minorities are multifaceted, collaboration among sponsors, sites, and communities is necessary for increasing diversity. To increase diversity and inclusion, sponsors may want to consider:
Supporting successful recruitment
The decision to participate in a clinical trial is one that patients with cancer do not take lightly. Though they often have strong connections with their oncologists, it is rare for patients with cancer to agree to participate in a study when it is first presented to them. Consent typically requires a series of in-depth conversations among the patient, their caregivers, the investigator, and even the referring oncologist. As such, it is essential to provide investigators and sites with engagement materials to support these discussions.
Working with sites to identify specific time points or procedures where eligible study participants can be identified is also important, especially given the number of physicians or departments that may be involved in a patient’s care. This includes identifying potential referral pathways and implementing processes to ensure patients feel supported throughout any provider transitions.
Increasing retention by mitigating risk
Retention is put at risk any time a patient feels unsatisfied or concerned about any aspect of study participation. Identifying and mitigating these risks during study planning can facilitate recruitment and retention. Common risk mitigation strategies include free valet parking to minimize walking distance, travel reimbursement, and on-site childcare options. VIP programs, where patients are recognized with a study lanyard and given priority for tests and procedures, when possible, are also effective. Perhaps the most effective risk mitigation strategy is eliminating out-of-pocket expenses entirely through the provision of vouchers or prepaid cards. Concierge services are available to handle the logistics of travel planning for patients and their families.
Creating a study community
Fear and anxiety are the primary drivers of early discontinuation in cancer trials. The most successful retention programs focus on providing ongoing education and fostering a sense of community:
Patient education. Letting patients know how important their commitment is and what to expect at each study visit can help to allay anxiety and uncertainty. Providing an electronic version of the study schedule or sharing videos on key aspects of participation can be highly effective. Data sharing is also a powerful approach to ensuring a positive trial experience. Patients want to know they are part of something bigger than themselves.
Patient communities. Establishing meaningful connections and mechanisms for feedback allows sponsors to ensure that patient voices are heard throughout—and beyond—the duration of a study. Social media platforms and partnerships with advocacy groups are valuable for garnering unbiased viewpoints and uncensored perspectives. Patient engagement specialists or contract research organizations (CROs) with experience in this area can serve as the conduit between sponsors and patients, enabling authentic, candid conversations that increase study awareness and participation.
About the Authors
Ashley Herrick, PhD (left), is Executive Director, Oncology Program Strategy, and Nicole Carswell (right) is Executive Director, Patient Engagement & Recruitment, both at Premier Research.