Putting People at the Center of Clinical Research: Patient Centricity at Moderna

At Moderna, our platform is about human health and maximizing the impact of mRNA medicines. An important way that we advance our mRNA pipeline is through our clinical trials. Historically, clinical trials have been conducted primarily at hospitals, clinics, or physician offices requiring in-office study visits, which may limit access and may result inadequate demographic representation.

Moderna is pioneering patient centric approaches to clinical trial conduct that enable participants to be the main contributors to their clinical trial experience. We aim to break down barriers and make it easier for people from all backgrounds and across all geographies to participate in clinical trials.

What is Patient Centricity?

At Moderna, patient centricity means bringing participants into the clinical trial process at every stage of development. Instead of thinking about how to conduct our trials from the Moderna view, we consider how to best conduct clinical trials from a participant’s perspective. This includes everything from how we gather insights from stakeholder groups, to how we raise awareness with the goal of increasing clinical trial access, to how we engage with participants at and after completion of trial participation.  The participant experiences are at the forefront of every decision we make.

Flexible Protocol Designs

An essential component of the clinical trial process is designing the protocol. Moderna takes a refreshed approach to protocol design by having the Patient Centricity Team review every protocol solely through the lens of how to best reduce trial burden for participants. We evaluate the schedule of assessments to assure it aligns as closely as possible with the participant’s healthcare journey, and we consider incorporating methods that could provide participants options in their clinical trial experience, such as home health, travel and logistics coordination. However, we have learned that you cannot take a one size fits all approach to these methods. For example, while some individuals may benefit from home health, others in the same clinical trial population may prefer or may even need to be seen in the clinic. Creating flexible protocols creates choice for participants, which is imperative in truly patient centric protocol designs.

At Moderna, we also review our protocols to ensure that they are written in a health literate manner. Even though protocols are not shared with participants, it is extremely important that they are written clearly so that clinical trial researchers can easily comprehend and effectively communicate the trial requirements to participants. Clear and concise information up front can allow for a better education and communication process to participants.

Meeting Participants Where They Are and Partnering to Expand Trial Access

Historically, clinical trial sites mostly enroll participants from the same community.  In order to give more diverse people access to clinical trials, we recognize the need to leverage partnerships that bring clinical trial activities into new communities. We do this through partnerships with retail pharmacies, through mobile units and pop-up clinics as well as through other novel solution providers depending on the geographies and regions to create fit-for-purpose strategies.

Incorporating Participant Voice

It is vitally important for us to incorporate the participant voice throughout the full clinical development process whether it be prior to protocol design, during trial participation, or post trial. There are many methods to do this as well, such as through patient focus groups, protocol simulations, market research and participant experience surveys. Moderna is developing a full framework that encompasses incorporating these insights into the full spectrum of the clinical trial process that provides a comprehensive qualitative and quantitative approach to incorporating insights at the right place, at the right time, and in the right way.

Looking Ahead

While we are making great strides in designing patient centric trials, we know our work is not done. We will continue to relentlessly pursue innovative approaches to the clinical trial experience to advance important research and ensure that participants’ engagement with Moderna is the best experience that it can be.

We know that science and clinical outcomes may only be advanced for all people and patients if they are adequately represented in clinical trials. By pioneering new ways of conducting our clinical trials, we are helping to maximize the impact of our mRNA medicines on all populations from the start.