The pharmaceutical industry has witnessed a transformative shift in patient engagement approaches for clinical trial design, driven by the COVID-19 pandemic's push toward virtual solutions. This evolution presents both opportunities and challenges for ensuring trials effectively meet patient needs in the post-pandemic landscape.
Virtual Engagement Expands Access
The transition to virtual engagement has opened doors for previously underserved patient populations. Health advocate Trishna Bharadia highlights the particular impact on the MS community and those with disabilities. "I know a lot of people in these communities who haven't been able to engage with clinical trials and patient engagement opportunities in the past because they can't, for example, get out of the house for a whole day," she explains.
The NIHR Clinical Research Network has received overwhelmingly positive feedback on virtual engagement initiatives. Gareth Powell, business development officer at NIHR, notes, "They're not having to travel to speak to researchers in person anymore. We've got greater flexibility in being able to do research at a time of their choosing."
Balancing Digital and Traditional Approaches
While virtual solutions show promise, industry leaders caution against a one-size-fits-all approach. Shona Fraser, head of clinical research for Janssen UK, shares insights from early pandemic experiences: "People in the trial were predominantly older... Their use of technology was perhaps not as strong as somebody from a different generation."
Janssen has developed a structured approach featuring seven engagement touchpoints throughout the development cycle, ensuring comprehensive patient involvement from concept to completion. Fraser emphasizes the importance of maintaining personal connection: "We can't just say 'Here's an app, fill it in. Thanks very much.'"
Innovation in Youth Engagement
The industry is also making strides in engaging younger patient populations. UCL medical student Adit Bassi highlights the importance of using age-appropriate platforms for youth engagement, noting that traditional video conferencing may not always be the most effective approach. Alternative platforms such as Jamboard, Google Docs, and Slido have proven more successful in encouraging participation among younger patients.
Future Directions and Best Practices
Bryan Deane, director of new medicines and data policy at the ABPI, emphasizes the need for systematic change: "We need to go right back to the beginning and say, 'How do we understand the unmet need in various diseases?' We need to talk to the patients at that point."
To facilitate compliant patient engagement, the ABPI has launched a sourcebook guiding pharmaceutical companies on working with patients and patient organizations effectively. This resource aims to address industry concerns about patient interaction while maintaining regulatory compliance.
Collaborative Path Forward
The evolution of trial design requires ongoing collaboration among all stakeholders. As Bharadia concludes, "The responsibility lies with every stakeholder group... We're all working towards the same thing, and that's to improve outcomes for people who are living with health conditions."
Industry experts agree that maintaining flexibility and continuing to innovate in patient engagement approaches will be crucial for future success. The focus remains on creating trial designs that not only meet scientific rigor but also address real patient needs and circumstances.
