Advancing Innovation in Dermatology (AID) is pleased to be one of the organizations partnering with the Digital Medicine Society (DiMe) on a project to advance nocturnal scratch as a digital endpoint for atopic dermatitis. We had an opportunity to speak with Jennifer Goldsack, CEO of DiMe; Lucy Cesnakova, a program lead for the nocturnal scratch initiative; and Ashley Blua, a patient ambassador of National Eczema Association, about the significance and potential impact of the project.
Could you tell us a little about the Digital Medicine Society (DiMe) and the organization's overall mission?
- Jennifer: The Digital Medicine Society (DiMe) is the professional home for experts from all disciplinary backgrounds who share our commitment to advancing the ethical, effective, equitable, and safe use of digital medicine to redefine healthcare to improve live. We pursue this mission through community building, research that generates actionable solutions to the most pressing challenges facing the field of digital medicine, and a variety of communication and education initiatives. What does that mean in practice? We bring together leaders in the field to generate open-access resources such as The Playbook – a comprehensive resource about digital clinical measures; recurrently update our library of digital endpoints; and collaborate on IMPACT, our work to improve the use and access to virtual care.
DiMe has organized a collaboration with a consortium of leading pharmaceutical companies and patient groups to advance nocturnal scratch as a digital endpoint for atopic dermatitis. Could you tell us what led to the start of this novel project and the importance of incorporating the patients' perspectives into it?
- Jennifer: This project was initiated by leaders in the pharma industry who came to us to leverage our convening and research capabilities, and partner on an initiative to unify the approaches to development of novel endpoints. Digitally measured nocturnal scratch was the perfect use case – the field of dermatology is leading the field in digital innovation and there is substantial unmet patient and clinical need for a novel digital measure of nocturnal scratching to better serve patients with atopic dermatitis (AD). We are thrilled that our partner organizations are willing to participate in pre-competitive collaboration to realize the promise of sensor-driven measurement more quickly for the benefit of patients rather than each on their own. Overall, we believe this work will serve as the blueprint for digital endpoint development excellence in the digital era of clinical development.
- Lucy: And while the collaboration of big industry names is great, we knew we couldn’t only work with pharma researchers. We knew immediately that we needed patient input to eradicate any researchers’ assumptions about their experience with the disease or its symptoms. We contacted several AD patient advocacy organizations and were able to partner with amazing patient ambassadors who shed so much light on everyday struggles of people and parents of children with eczema. Their input on the project’s work so far has been invaluable.
What has been your experience so far collaborating with DiMe and the consortium on this project?
- Ashley: My experience collaborating with DiMe and the entire consortium on the Nocturnal Scratch project has been nothing short of rewarding. As a lifelong AD sufferer, providing insight on behalf of patients is a role that I take very seriously. Nocturnal Scratch is a severe aspect for many AD sufferers, including myself, and the DiMe team and other collaborators took my insights and experiences seriously to help better inform this study. Being a part of this project also gives purpose to my pain. AD is an incredibly difficult disease and has held me back in various ways throughout my life - but being able to come full circle and use those experiences to help others makes it very worthwhile.
What outputs of the project are you looking forward to?
- Jennifer: We will launch a comprehensive suite of resources in September that will address measurement science needs, operational best practices, regulatory science needs, and considerations for commercial success. I'm personally excited about the results of the study we've been working on, which combines patient interviews and a large scale survey about the effects of AD and nocturnal scratch on their lives. We've discovered some pretty interesting results supporting the need for a new passive and rather objective assessment adjacent to standard measures. I'm also excited about a toolkit of recommendations to deploy the measure in clinical trials, framework for work with payers, and proposed terminology and ontology to define the measure for future R&D endeavors.
- Ashley: I'm looking forward to the results and outputs from this research, particularly how the lack of sleep may be impacting AD sufferers in their daily lives. The use of wearable technologies to measure this is incredibly fascinating and I believe will continue to open doors for the use of new technologies in the search to help end - or at least ease - AD. From a patient perspective, the results of this research can also help validate and provide a voice to those of us who are or have struggled with nocturnal scratch.
What were the major accomplishments and most important learnings for you so far?
- Lucy: On the research side, I have to say it's been greatly satisfying to see the reports coming in from 49 interviews with adult patients, as well as child patients with their parents. These reports are providing a lot of evidence about nocturnal scratching and disturbed sleep in AD patients. On the collaboration side, it's also been a great accomplishment to see such an engaged group of experts, collaborators, and partners participating on the project. We've held two successful workshops with expert stakeholders from clinical, patient, technology developer, and payer backgrounds. These conversations taught us a lot and we're now working hard to put the learnings on paper to make them broadly accessible with the R&D community, and anyone looking to improve the research and understanding of AD.
Want to learn more about advancements in wearable technologies?
Check out the Advancing Innovation in Dermatology and Querrey Simpson Institute for Bioelectronics at Northwestern University hosted Dermatology Innovation Webinar featuring academia and industry speakers as they discuss opportunities and challenges for novel sensors in clinical trials.
