Addressing the Expanded Role of Patient Engagement in Clinical Research

COVID-19 has triggered widespread uncertainty in our industry, clearly demonstrated by the number of clinical trials that have stopped, slowed, failed to start, or are otherwise impacted by the safety limitations driven by the pandemic. More than ever, sponsors requireremote solutions to ensure that trials can continue, and patients can be cared for, while still capturing the reliable data needed for regulatory submissions.

The clinical trial industry has been primed for such disruption and is willing to adopt new technologies that can provide insights about disease burden and the benefits of various treatment approaches. Before COVID-19, however, despite the existence of technology for remote, yet personal, engagement with patients, uptake of these tools was slow across the industry. Amid the challenges that have reduced and prohibited site visits, the clinical trial industry has finally seen the fundamental shift needed and has pivoted toward rapid adoption and implementation of future thinking tools that allow for high-quality patient engagement.

Efficient and effective patient engagement

Patient engagement has become critical as it promotes patient autonomy, increases safety, helps to set reasonable expectations,and results in patientcentered decision-making. Over the years, we have rapidly designed and equipped patients with engagement tools that provide the support and information they need, and that the clinical trial environment demands. We know that patient knowledge, skills, ability, and willingness to manage their own care becomes critical in ensuring that those facilitating trials will capture accurate and consistent data.

To ensure that patients have the support they need to successfully meet trial protocol obligations, we are utilizing a suite of innovative engagement tools, such as integrated video visits, compliance alerts and reminders, twoway SMS and email messaging with sites, visit calendaring, caregiver support, gamification and more. In addition to protocol obligations, deployment of such tools has been critical to communicating the status of patients’ trials, revised safety information, changes to visits, or shifts to other trial activities. Such features increase patient autonomy and awareness that are so integral to ensuring that patients are holistically supported.

Bringing video to clinical research

While video has previously been utilized across multiple types of healthcare interactions, from consultations with primary care physicians to regularly scheduled visits, it also provides immense value to clinical research, where patients are committed to the development of treatments that may benefit others and are often making significant personal sacrifices related to their time and their health. The current global COVID-19 crisis further raises the stakes for patients in active trials due to the uncertainty of this disease and the added risk to trial participation it creates. Trials that would have been placed on hold or discontinued due to site visit safety concerns and healthcare resource reallocation driven by COVID-19, have been able to mitigate these challenges by transitioning to video interactions.

Looking forward, these video visits need to be integrated with other trial engagement features to offer a seamless conversion of study visits and remote protocol obligations without rescheduling. Such patient engagement solutions can serve as a “one stop shop” or “hub” to help manage patient needs by providing consistent and reliable messages about their treatment and study. Essentially, any information you can offer to a patient in paper form should also be readily available digitally where they are and on their device. As we adapt to remote trials, the effectiveness of these engagement tactics to support the needs of patients should be measured through regulatory review of trial data, sponsor and institutional assessments, and survey of patients completing these research programs.

While patient engagement and technology adoption in the clinical trial industry are fundamentals for evolving research methodologies, the past few months have been both challenging and an exciting journey. One benefit of the global pandemic is that it provoked a sense of urgency in developing alternative methods to care and placed a greater emphasis on patient’s choice in how to participate in clinical trials. As we grow accustomed to the “new normal” and define what this global pandemic means for generations of clinical trial participants, researchers and sponsors, we are looking forward to granting patients control of their own experience. The momentum has started, and I anticipate patients will only become more involved, more engaged, and more active in their disease treatment and management