In our recent Trailblazer webinar, we had the opportunity to delve deep into the challenges and complexities of oncology clinical trials and the impact on patients. We had the honor of hosting an esteemed panel that included Greenphire’s CEO, Jim Murphy, joined by Elizabeth Barksdale, Associate Director of Regulatory Affairs and Scientific Policy at Lungevity and Mark Fleury, Principal, Policy Development, Emerging Science with the American Cancer Society.
Together, they shared their invaluable insights and expertise, shedding light on the pressing issues in today’s clinical trial industry.
A Journey Towards Better Patient Convenience
A major challenge faced by clinical trial participants is the inconvenience of traveling to and from the trial sites. According to our data, the average distance covered to reach an oncology clinical research site is a lengthy 57 miles, indicating a prominent travel burden on participants. As patient convenience is a crucial determinant to successful clinical trials, it is important for sponsors to address these challenges and offer assistance for travel and accommodations. In fact, according to a survey conducted by the American Cancer Society (ACS), 79% of respondents indicated that sponsor support for lodging and transportation would make them more likely to enroll in a trial outside of their local area.
Role of Sponsored Support and Reimbursement
Compensating participants for their involvement in a study is not only necessary, but also crucial for ensuring their continued participation. Therefore, it’s important to provide reimbursement not only for travel expenses, but also for their time, caregiver’s time, and any other associated costs. Afterall, oncology trials can be particularly burdensome – according to the 2021 Tufts Impact Report, oncology trials are 30-40% longer in duration than other drug trials due to more complex designs and difficulty finding, enrolling and retaining study volunteers.
Providing assistance for services such as childcare, elder care, and pet care can be instrumental in removing various barriers that result in certain groups being less supported. Participants are typically reimbursed for some of these costs, but the processes need to be simplified and additional costs need to be considered.
Impact and Future of Remote Trials
During the COVID-19 pandemic, there was a shift towards remote trial options and telehealth visits. However, as the pandemic began to recede, in-person visits started becoming more common again. While remote and hybrid trials have their advantages (e.g., enabling continuity of care), concerns remain about the accuracy and completeness of data collected during remote visits. It is important to strike a balance between in-person and remote trial options to ensure efficient and convenient participation while still collecting high-quality data.
Mark shared his views on the hurdles of running clinical trials in home environments compared to clinical settings. He believes that more comprehensive sample sizes might be required to compensate for potentially missing data and emphasized the importance of learning from these challenges to improve future trials. With that said, however, there is still value in virtual/hybrid trials, and we should consider their use in specific instances to enhance patients’ quality of life.
The Power of Human Connection
While remote and hybrid trials have their place, the need for research sites will never fade. Elizabeth shared a compelling anecdote about an oncology trial failing to enroll participants due to the preference for face-to-face doctor-patient interactions. Her experience highlights the significance of trust in steering clinical trials. This trust is built through face-to-face interactions between the doctor and the patient, which are often more challenging to establish in remote or hybrid trials. Human connection plays a vital role in addressing participant’s concerns and putting them at ease, increasing their willingness to participate.
Navigating Legal, Regulatory and Policy Considerations
Clinical trials are often hindered by legal and policy regulations. Some laws, like the anti-kickback statute, could discourage sponsors from offering financial support to patients. However, it is necessary to establish regulatory safe harbors to encourage such support.
In the same vein, financial support provided to patients during clinical trials should not be considered as income. Jim highlighted that crossing the $600 threshold for stipends might lead to negative consequences for patients, such as affecting their eligibility for other benefits. This emphasizes the importance of introducing policies that decrease financial burdens on patients and advocate for equitable access to clinical trials.
As we continue navigating the complexities of oncology trials, it is essential to keep in mind that the ultimate goal is to improve patient care and outcomes. We must place participants at the core and prioritize patient convenience throughout the clinical trial process. By doing so, we are working towards improving the quality of cancer care and making oncology trials more accessible, ethical, and successful.
Discover how you can reduce the burden on participants in oncology trials today. Learn more by:
- Getting to know our Patient Convenience Solutions
- Watch a replay of the webinar here
