How COAs and DHTs offer deep insights into patient experiences and treatment effects
A Q&A with Sonia Bothorel, Managing Director, Mapi Research Trust and Outcome Measures Solutions
What aspects of the Life Sciences industry are you most passionate about, and how does that play into your current role leading Mapi Research Trust and the Outcome Measures business within ICON?
I’m very passionate about areas within Life Sciences that directly impact the health and quality of life of humans. My career goal is two-fold: to have a meaningful impact on the world and to engage in continuous learning.
Mapi Research Trust (MRT), an ICON plc company holds a special place in the Life Sciences landscape due to its mission to promote Clinical Outcome Assessment (COA) research and advance patient-centered research. What sets MRT apart is its agnostic approach to COAs, coupled with its commitment to advancing research and science in this crucial area.
The emphasis on patient centricity at MRT and ICON resonates deeply with my personal motivations. Our position as a neutral party in the field allows us to focus solely on supporting and furthering research that ultimately benefits patients. This aligns perfectly with my desire to have a tangible impact on something meaningful.
Moreover, the nature of our work at MRT provides constant opportunities for learning and growth, satisfying my intellectual curiosity and drive for continuous improvement. By leading an organization that exists to support and further patient-focused research, I feel I'm contributing to the broader goal of improving human health and quality of life - the very aspects of Life Sciences that initially drew me to this field.
What inspired you to advocate for the acquisition of HumanFirst, the creator of the Atlas platform for digital measuers, into ICON?
Advocating for this acquisition was about recognizing a unique opportunity to create something truly innovative for our industry that could accelerate the pace at which we bring life-changing treatments to those who need them most.
Initially, I, along with colleagues at ICON, were impressed by HumanFirst's unique combination of scientific robustness and cutting-edge technology. The more I worked with HumanFirst, the more I believed that together, we could create an industry-defining offer that could significantly advance patient-centric clinical research: a way to bridge the gap between digital health technologies (DHTs) and clinical outcome assessments (COAs).
The potential for such a solution became even more apparent during our collaboration on a paper published in NPJ Digital Medicine. I was struck by the immense value that a combined DHT and COA platform could offer to the industry. I envisioned a solution that could significantly enhance our ability to capture and understand the patient voice in clinical research. By combining DHTs with traditional COAs, we could potentially reduce the burden on patients participating in trials while simultaneously capturing more comprehensive and nuanced data about their experiences.
Ultimately, my advocacy was driven by a desire to further amplify the patient voice in clinical research and to accelerate the development of new treatments that can improve quality of life. By bringing together the strengths of HumanFirst and Mapi Research Trust under ICON, we can create a more holistic approach to patient-centered research.
How do you see digital measures and technologies transforming the landscape of clinical research and patient-reported outcomes?
The integration of digital measures and technologies into clinical research represents a transformative shift in our approach to understanding patient experiences and disease progression. What's truly exciting is the synergy created by combining digital health technologies (DHTs) with traditional clinical outcome assessments (COAs). When used together, COAs and DHTs can provide a more comprehensive understanding of patient experiences.
One of the most significant advantages of this combined approach is the ability to collect both active and passive data. Whereas COAs typically involve active data collection, where patients consciously answer questions about their experiences, DHTs, particularly wearables and sensors, allow for passive data collection. This means we can gather valuable information about a patient's condition or response to treatment without requiring constant active engagement from the patient. This dual approach not only reduces the burden on patients but also provides a more complete picture of their health status and treatment outcomes, which could lead to the development of more targeted and effective treatments that truly address the needs and priorities of patients.
This approach also has the potential to make clinical trials more inclusive and representative. DHTs can allow for remote monitoring and data collection, expanding access to trials for patients who might otherwise be unable to participate due to geographical or mobility constraints.
As we continue to refine and expand these methodologies, I believe we'll see significant advancements in our ability to improve patient outcomes and quality of life across a wide range of conditions.
What are some of the key challenges you see in advancing clinical outcome assessments in clinical trials?
In my experience, the key challenges in advancing COAs in clinical trials are primarily operational in nature. These challenges often stem from the complex interplay of various stakeholders involved in the clinical trial process, each with their own priorities and perspectives.
One of the most significant challenges is the coordination of the process and the coordination between different stakeholders. The lifecycle of a COA and its electronic implementation (eCOA) in a clinical trial involves numerous parties - from researchers and clinicians to regulatory bodies and patients. Each of these stakeholders may have different interests, priorities, and constraints, which can sometimes lead to misalignments or inefficiencies in the process.
Another key challenge is that there are still gaps in understanding the full value that COAs can bring to clinical trials. While there's growing recognition of the importance of patient-reported outcomes, some stakeholders may still underestimate the crucial insights that well-designed COAs can provide. This can sometimes lead to COAs being treated as an afterthought in trial design, rather than being integrated as a core component from the outset.
Also, there are still some gaps in the understanding of the steps that should be followed in implementing COAs effectively. While there are guidelines and best practices, the process of selecting, implementing, and analyzing COAs can be complex, and not all stakeholders may be fully versed in these processes.
The rapid advancement of technology in this field, while offering many benefits, also presents its own set of challenges. The shift towards eCOAs, for example, offers many advantages in terms of data quality and patient convenience, but also requires new skills and infrastructure that not all organizations may have readily available.
I believe addressing these challenges will further the value and proper implementation of COAs and aid in the development of more standardized, yet flexible, processes for integrating COAs into clinical trial designs.
What advice would you give to pharmaceutical companies or researchers looking to implement COAs and DHTs more effectively in their clinical trials?
I'm encouraged to see the increasing adoption of COAs in clinical trials. This trend reflects a growing recognition of the value these tools bring to the research process. To any researchers looking to implement COAs and DHTs more effectively, I would offer the following advice:
- Engage early and plan comprehensively: Engage early in the process and thoroughly understand the different steps involved. This early planning allows you to better anticipate costs, timelines, and potential challenges.
- Adopt a targeted approach: Rather than including a long list of generic assessments in your protocol, consider a more targeted approach with fit for purpose COAs.
- Involve patients in DHT selection: Patient insights can be invaluable in ensuring you choose the most effective and user-friendly devices for your study population.
- Consider the full picture: Remember that DHTs and COAs are complementary tools. While they won't replace each other, using them in combination can provide a more comprehensive understanding of patient experiences and treatment effects.
- Stay informed on regulatory guidance: As this is a rapidly evolving field, staying up to date with regulatory expectations can help ensure your implementation strategy aligns with current standards.
By following these guidelines, pharmaceutical companies and researchers can more effectively implement COAs and DHTs in their clinical trials. This approach not only enhances the quality of data collected but also ensures that the patient voice is central to the research process, leading to treatments that more effectively address patient needs and improve quality of life.
Sonia Bothorel