Takeda’s Head of R&D Patient Engagement Jessica Scott examines the parallels between partnering with patients and working remotely with colleagues in the time of COVID-19.

Patients need us to engage with them, ask questions and listen. Just as we’re experiencing now with our own work relationships with colleagues, deeper connections build trust, which in turn leads to better outcomes for individuals and teams

Among the many changes in life we are all experiencing since the arrival of COVID-19, the profound shift in the nature of our connections and conversations with colleagues may actually give us a window into better understanding what life is like for patients and how we might be better partners for them in the process of drug development.

Perhaps ironically, as we are working from home and are more physically distant and isolated from each other, many are feeling more connected with colleagues and friends. We share experiences and challenges and “see” a glimpse of one another’s lives through video meetings. We discover we’re not alone in feeling anxious and fearful about this global health crisis, nor are we alone in the need to simultaneously juggle personal and family responsibilities, financial strain or even worse, grief.

We are keenly interested in connecting on a more personal level with a much wider set of colleagues than we had in the office. We see that at-home situations collide with professional interactions and the implications for our colleagues. We now ask what they need from us in terms of flexibility or support. Children are home and may need time and attention during work hours, sick or stressed family members’ needs may be more urgent and critical than work priorities. While at the same time, we need to continue to be productive with work or other demands. Feeling empathy and understanding from others about the challenges in our lives makes us feel less alone and overwhelmed. Anxiety subsides as we feel connection and sense that we are being heard. We feel the burden of stress lifting and giving way to hope, and we are able to work together more effectively.

Quite interestingly, this is precisely what patient engagement in the process of drug development is all about — seeing the patient in the context of their lives, not just their illness. In fact, feeling isolated, distanced, anxious and scared is what people living with medical conditions and their loved ones deal with on a regular basis. They want us to hear them and deeply understand their experience so we can design trials and develop new medicines that will truly meet their needs. We wonder as an industry why it is so difficult to recruit patients into clinical trials and stay through to the end. Yet, we are only beginning to understand from their perspective, which aspects of a trial create the most burden and why. We need to understand patients’ needs in their health crises and the pervasive impact of their conditions on their families, work, and emotional well-being when thinking about a potential medicine to address these needs in ways current medicines do not. By better understanding and responding to unmet needs, we can develop more medicines of value to patients and less burdensome clinical trials as part of the process.

Because patients are our most important partners in the R&D process, building relationships that enable us to earn and retain their trust is essential for drug development. In this COVID-19 environment, we are learning insights about our colleagues that help us make more meaningful connections with them and work in a more collaborative way. What insights about patients’ lives and experiences would be most meaningful in helping us decide whether to try a new medicine? By partnering in the process of drug development, we can understand the evidence patients want to make healthcare decisions. For example, what risks would they be willing to tolerate in exchange for certain potential benefits?

The new realities of COVID-19 and recent Regulatory Guidance documents recognize the need for trial adjustments to maintain patient safety, including virtualization that actually aligns quite well with feedback about trial design and conduct we learned from our 2019 patient engagement activities at Takeda. Examples include:

• Fewer site visits and more at-home monitoring during clinical trials will not only help during this global pandemic but will also better meet the needs of patients for whom travel is difficult in normal times.
• Routine communication will keep study participants well-informed about how a trial is progressing and what can be expected.
• Minimizing sampling and imaging requirements to what is essential for the study rather than including additional samples for multiple exploratory endpoints will reduce patient burden and complexity and may deter participants from enrolling or completing trials.

Patients need us to engage with them, ask questions and listen. Just as we’re experiencing now with our own work relationships with colleagues, deeper connections build trust, which in turn leads to better outcomes for individuals and teams. Like any collaborator, patients want us to be open to factoring their perspective into our decision-making. Understandably, they would also like to know how their feedback added value toward the development of new medicines for them or future patients. In addition, they need us to be clear and set realistic expectations including the fact that although each trial helps advance science, most investigational medicines will not make it through the drug development process and achieve regulatory approval. A deeper level of understanding of patients’ experiences will help us focus on what matters most to patients, demonstrate safety and efficacy, and share the body of evidence together with patients’ perspective for regulatory decision-making.

We need to shift our mindset from developing medicines for patients to developing them with patients. To do that, we need to connect with patients on a whole new level. We can bring learnings from our experiences as we work during this COVID-19 crisis to help make this change in mind-set happen by demonstrating our understanding and empathy for their situations, by building authentic and reciprocal relationships and by having the flexibility to make changes based on what we learn.

References

• “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency,” U.S. Food and Drug Administration (“FDA”) (updated March 27, 2020),
• “Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 2,” European Medicines Agency (“EMA”) (dated March 27, 2020)
• “Guidance: Managing clinical trials during Coronavirus (COVID-19),”United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”) (updated March 24, 2020)