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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSExciting news: The Apple Watch’s atrial fibrillation (AFib) history feature has achieved a significant milestone by becoming the first-ever digital health technology to qualify for the FDA’s Medical Device Development Tools (MDDT) program as a class II photoplethysmography (PPG) analysis software for over-the-counter use.
The feature estimates how frequently the user shows signs of the irregular and often extremely rapid heartbeat associated AFib and derives AFib burden estimates (i.e., the overall duration of AFib as a percentage of the total time assessed). The presence of a high burden of AFib is linked to gradual structural changes in the left atrium, including dilatation, wall thickening, and fibrosis.
The recent FDA approval allows its use as a secondary (surrogate) endpoint in clinical studies evaluating the safety and effectiveness of cardiac ablation devices, specifically for users aged 22 years and older. This achievement underscores the importance of wearable technology in healthcare, particularly for monitoring heart health.
To qualify, Apple combined insights from the famous Apple Heart Study with a prospective clinical study involving 280 subjects with permanent (subjects with known history of paroxysmal or persistent AFib) and non-permanent AFib. The accuracy of the Apple Watch’s weekly AFib burden was compared to data collected using the Cardea SOLO Wireless ECG Patch, resulting in an average difference of 0.67% with a 95% confidence interval of (-0.05%, 1.38%). Most subjects (92.2%) had paired weekly AFib burden differences within ±5%, demonstrating generalizability across user populations.
An exploratory analysis evaluating device performance across various AFib burden levels revealed minimal absolute differences between the subject device and the reference device (<2.06%). The digital measure showed poorer performance in a sub-group of patients who had undergone ablation treatment; however, these results may be attributed to the limitations of the study design (e.g., the sub-group had a small sample size). Sub-group analyses by sex, race, ethnicity, age group, and skin tone showed similar device accuracy. The tool, however, does not identify atrial tachyarrhythmias other than AFib, limiting its use to a secondary endpoint. Further, clinically important outcomes have not been established. The application requires wearing the device at least 12 hours a day, five days a week, and it also allows users to log lifestyle factors that may influence their condition, such as exercise minutes, sleep patterns, and alcohol consumption.
It’s indeed compelling that the first sensor-based Digital Health Technology (sDHT) for assessment qualified by the FDA is a digital biomarker (specifically, a surrogate endpoint) rather than a digital “true endpoint”. However, this outcome aligns with the context of cardiac ablation devices and antiarrhythmic drugs, where biomarkers of cardiac function (e.g., AFib burden) have traditionally been accepted as surrogate endpoints for validation.
Research has recognized that endpoints based on AFib burden may hold greater clinical significance than simply measuring the time to the first recurrence of arrhythmia. However, accurately assessing AFib burden poses a challenge, as it ideally necessitates continuous recording of the date, time of onset, and duration of each arrhythmia episode. Notably, clinical studies like PROGRESSIVE-AF and NOVA, among others, have investigated AFib treatment and incorporated AFib burden as an efficacy and effectiveness measure by using an inserted cardiac monitor. External devices like smartwatches and loop recorders do not provide continuous or sufficiently long-term monitoring and are not considered accurate enough for quantifying AFib burden. In this context, the qualification of the Apple Watch feature represents a significant shift in clinical assessments, offering a non-invasive, user-friendly solution for patients and potentially paving the way for other qualifying devices in the future.
sDHTs have two distinct pathways for qualification. The first pathway involves seeking qualification as a Drug Development Tool (DDT) through the Clinical Outcome Assessment (COA) Qualification Program, which covers both COAs and other types of measures relevant to drug development. Alternatively, DHTs can choose to seek qualification as a Medical Device Development Tool (MDDT) if they are primarily used for medical device development. The question that remains is whether the COA Qualification Program would have accepted the Apple Watch’s AFib history feature to support label claims.
As wearable technology continues to shape healthcare, it’s crucial to recognize the importance of digital biomarkers and their importance as surrogate endpoints. However, we must also acknowledge the unique value of ‘true’ endpoints—those that directly capture how patients feel, function, and survive. Prioritizing both types of endpoints brings us closer to patient-centric healthcare, supporting efficient progress.
This marks the first FDA qualification of a digital measure as a secondary endpoint. In this case, the digital biomarker was already established, and the approval focused on demonstrating that the device is fit-for-purpose. It represents an initial step toward approving more novel and innovative digital measures.
Questions about how you can use DHT in your research? Contact our experts at pcsbd@iqvia.com.
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