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Written by Sylvain Zorman, PhD |
The Digital Endpoint Collaboration to accelerate Outcome DEvelopment (DECODE) Nocturnal Scratch working group was launched in November 2023, with the goal of bringing to the market a fit-for-purpose digital measure of nocturnal scratch. A project like DECODE-Nocturnal Scratch is an opportunity to advance patient-focused drug development in dermatology, as well as to provide additional clinical insight into the efficacy of treatments to increase the probability of success and differentiation.
For the DECODE-Nocturnal Scratch working group to achieve these outcomes, a rigorous validation process is necessary to demonstrate that the new digital measure is robust and accurate. In March 2024, the validation study received IRB approval, a key milestone for the project. The clinical study is designed to support the analytical validation of a digital measure of nocturnal scratching behavior by including a night vision camera, polysomnography (PSG), Clinician-Reported Outcomes (ClinRO), Patient-Reported Outcomes (PRO), and the ActiGraph LEAP™.
However, the FDA has recently highlighted that sponsors and technology providers must also ensure the digital health technology (DHT) can effectively be used by the patients and that burden is minimized. Usability evaluation is a key part of the FDA’s final guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, which focuses
on the ability for participants to use the DHT properly in a remote setting and as intended in the study protocol. Usability validation was also recently added in the DiMe’s DATAcc V3+ framework, along with verification, analytical validation, and clinical validation, highlighting the importance of this step to ensure that DHT solutions are fit-for-purpose in the clinical trial ecosystem.
That’s why we’re excited to welcome IQVIA’s Patient Centered Solution group to DECODE-Nocturnal Scratch as a project collaborator. I had the opportunity to discuss their role in the DECODE project with Salma Ajraoui, PhD, Digital Practice Lead, and Rachel Bruce, Patient Experience Solutions Practice Lead from the Patient Centered Solutions (PCS) Team.
Salma has over ten years of pharmaceutical and consulting experience. In her current role as the leader of IQVIA PCS’ digital practice, she focuses on the advancement of strategies and methodologies for the development and validation of digital measures collected through sensor technologies in clinical trials and in the real world.
Rachel has spent the last 8+ years within life sciences consulting, 
focusing on patient experience and engagement strategy. As the leader of the patient experience solutions strategic consulting team, she is focused on providing support to pharma clients to design strategies, studies, and digital solutions that aim both to measure and to improve patient experiences across their journey in clinical development.
Q&A with Salma Ajraoui and Rachel Bruce
Sylvain Zorman: Can you summarize the focus of the Patient Centered Solutions group and what value your team can bring to the drug development process?
Salma Ajraoui: The Patient-Centered Solutions group leads the industry in the science of measuring patient experiences. We combine strategic consulting expertise with technical scientific knowledge to design and execute scientifically rigorous research. This research incorporates the patient's voice into the development and commercialization of new medicines. It includes qualitative approaches such as patient interviews and focus groups, quantitative methods like clinical outcome assessments (COAs)/patient-reported outcomes (PROs), preference research, and passive strategies using digital health technology tools to understand the experiences and expectations of patients, caregivers, and physicians regarding disease and treatment.
Our Digital Measures practice specifically focuses on reimagining the measurement of patient experiences in clinical and real-world studies. We establish strategies and methodologies for the development of fit-for-purpose digital measures collected through digital sensors. Continuous measurements allow for the understanding of variability and the exploration of trends in patient experiences within and between days. This is in contrast to single timepoint assessments and offers opportunities to broaden and deepen our view into patient functioning and the patient experience in real-world settings.
Rachel Bruce: The Patient Experience Solutions practice focuses on designing and preparing studies and digital solutions that will optimize engagement and experience for diverse patients in the field during clinical trials. The ultimate goal is to create a positive trial and user experience for patients and to gain robust patient experience outcomes.
Sylvain Zorman: What interested your team in the DECODE-Nocturnal Scratch project?
Salma Ajraoui: We believe in the power of collaboration to advance the science and understanding of digital measures and their application in various indications. Therefore, when ActiGraph expressed its intention to initiate this collaborative project, we were interested in participating.
The DiMe Nocturnal Scratch development work has identified key concepts in Atopic Dermatitis, such as sleep, scratch, and itch, that can be measured digitally or in combination with patient-reported outcomes. Initially, the DECODE Nocturnal Scratch working group is interested in validating nocturnal scratch as a standalone, fit-for-purpose digital measure in Atopic Dermatitis, with a specific focus on usability, which is of growing interest to regulators. Subsequently, the DECODE working group aims to explore the potential combination of both objective and subjective measures into a composite score, exemplified by the concept of sleep.
Sylvain Zorman: Your team will help design and conduct a patient survey following the clinical study. What aspects of usability will you be assessing?
Rachel Bruce: The survey will evaluate key aspects that may impact patient use of the ActiGraph device and thus affect integrity of the data collection. This includes aspects of:
- Comfort (e.g., how comfortable the device is to wear continuously during the day and night),
- Burden (e.g., convenience and any impacts on compliance),
- General ease of use (e.g., overall ability / confidence in use of devices, ability to put on and take off, ability to learn),
- Logistical aspects (e.g., connection, charging), and
- Training / support (e.g., clarity of instructions and setup).
Sylvain Zorman: From your perspective, what advantage(s) could a digital measure of nocturnal scratching behavior bring to dermatology drug development?
Salma Ajraoui: The benefits we see from using digital measures of nocturnal scratching in dermatology drug development are threefold:
- First, it provides a continuous, objective measure for the action of scratching in dermatological conditions, which will enable better monitoring and follow-up of the patient's condition, allowing for potentially shorter trials and smaller sample sizes.
- Second, it allows differentiation between the sensation of itch, which can be measured subjectively from patient-reported outcomes, and the action of scratching, which can now be objectively measured with the ActiGraph device. Indeed, these two concepts can sometimes be confounded by patients.
- Finally, adding a nocturnal scratching measure to other existing ones will provide a more holistic understanding of the patient's experience and allow for a better assessment of the effect of treatment on patients.
Sylvain Zorman: Clinical outcome assessments are designed to evaluate how the patient feels, functions, and survives. While objective measures of scratching behavior are valuable, what other evaluations are needed for a holistic picture of patient functioning?
Rachel Bruce: Objective measures need to be considered in complement with other clinical outcome assessments, such as patient-reported outcomes which can provide contextualization to the objective measure and provide a more complete and holistic understanding of the patient experience.
For more information about the use of digital endpoints in dermatology research, view ActiGraph's Digital Endpoint Resource Guide: Dermatology.