Being a clinical trial participant comes with many challenges, from balancing personal commitments to managing the demands of the study itself. Sponsors recognize these burdens and understand the need for “patient convenience” initiatives and solutions but still struggle with properly planning for costs and making appropriate accommodations to meet participant needs.
Recently, we spoke with Greenphire’s Director of Data Delivery, Katie Rothstein, to discuss how the industry is heading towards data-driven planning to optimize the participant experience. Read on for insights from our conversation.
Q: How would you describe the participant experience in clinical trials today?
A: Participating in a clinical trial can be a juggling act as individuals navigate their everyday commitments, including family, work, and other personal responsibilities in addition to managing the complexities of a medical condition. For example, consider a working single parent with young children, with one child participating in a clinical trial. They need to balance trial appointments, medication schedules, and related expenses, all while managing their job and caring for their children. Involvement in a clinical trial is not just a personal journey; it often Impacts the entire family.
Q: Why is there increasing awareness about the participant burden in clinical trials?
A: Clinical trial protocols are becoming more complex, which often means participants have to make longer and more frequent visits. Thankfully, there’s now a greater emphasis on understanding and enhancing the participant experience. With increased support from patient advocacy groups and guidance from the FDA, the focus is shifting towards making clinical trials more inclusive and representative of the actual population that will use the medical products. This change is bringing attention to the need for better support systems and smarter planning to improve the overall experience for participants.
Q: What obstacles do sponsors face when planning for the participant journey?
A: Even though many sponsors are rolling out support options and reimbursement initiatives to help ease the burden on participants, determining if they’re actually addressing the right needs holistically can be challenging. They often rely on historical data and assumptions that might be outdated or lack robust detail. Take, for instance, a participant in a rare disease trial that needs mobility support. Their challenges are going to be different from those of a healthy young adult in a dermatology study. Even within the same study, participants can have such differing needs and circumstances. Distance traveled, need for childcare, accommodations, where applicable, time away from work, family, etc. are examples of differing needs that directly impact the participant’s experience and out of pocket costs. The lack of detailed, real-world data makes it tough to plan for these potential scenarios.
Q: How does outdated data impact clinical trial planning?
A: When there is a reliance on old or limited information, it can lead to poorly informed decisions regarding how to support participants. It is crucial to remember that each study and each participant has unique needs. If there is no consideration for things like travel costs, childcare, or other logistical issues, the study might face delays and struggle with lower enrollment rates. Additionally, you might end up spending more money because you have to make adjustments during the study. Without accurate data, sponsors can’t properly budget for participant support, and that has the potential to have negative impacts to the overall timeliness of the study.
Q: How is technology driving change in the clinical trial space?
A: Technology is transforming the way clinical trials operate in their entirety. Specifically, participant experience technology is being leveraged to tackle issues like costs, logistics, and communication and is making participation more accessible and straightforward. However, it’s not just about making things easier; technology also lets us dive into the data over time to uncover valuable insights and trends. This means that clinical trials can run more smoothly, provide a more personalized experience for participants, and keep them engaged while minimizing delays.
Q: What does the future of data-driven patient support planning look like?
A: The industry is heading towards a more data-driven approach, which is a positive shift. With technology advancing, sponsors and study teams will have access to a wealth of detailed data categorized by key areas such as therapeutic area, region, or trial phase. This kind of information will help in planning and understanding the costs and challenges that participants encounter. Armed with these insights, sponsors can improve participant support and overall trial outcomes, which should lead to more successful and timely clinical trials.
Want to optimize how you plan for and execute the participant experience in your global clinical trials?
- Learn about our industry-first Patient Experience Dataset
- Or connect with an expert to discuss your trial needs