In recent years, let’s say since December 2021 when the FDA released a draft guidance on Digital Health Technologies (DHTs), clinical trials began to change due to embracing more and more technologies that collect digital endpoints. These technologies reshape how we conduct clinical trials, collect data, and ultimately, how we develop new treatments.
What are digital endpoints?
Digital endpoints are revolutionizing clinical trials by allowing more frequent, objective, and remote monitoring of patients. These endpoints use sensors such as smartphone microphones, wearables, sensors and digital pills to collect data outside of the traditional settings – hospital or clinic, offering a more direct, comprehensive and in real-time view of a patient’s health.
Picture this: a patient who participated in a dermatology clinical trial had to write down on a paper every time there was direct sun exposure for 6 months. This specific study was such a burden on the patient, especially for those patients living in a sunny location, isn’t it?
Now picture this other scenario: a participant in the same study wears a small, light sensor that measures in real-time the UV exposure this patient is exposed to and transmits it directly to the study data collection system – the ePRO, while also guiding the patient by alerting when the maximum allowed dose has been reached. Isn’t that much easier and convenient for the patient? It certainly is. But there are more benefits to digital endpoints in clinical research.
Why digital endpoints in clinical research?
Besides the straight-forward benefit of alleviating the burden of continuous assessments and unnecessary trips to sites, the integrations of digital endpoints in clinical trials presents several other advantages, both at the study level and for the participants:
Benefits at study level:
- Improved data quality:
Accessing continuous, objective data through sensors and wearables inevitably leads to more robust and reliable results. Data that does not rely on patients’ memory recall or subjective assessment. - Continuous measurement:
Digital endpoints allow for almost continuous data collection, providing a more complete and accurate picture of patients’ health. - Increased trial efficiency:
Remote monitoring of study participants ensures trial timelines are met and reduces the costs associated with in-person visits.
Benefits for the study participants:
Collecting digital endpoints in clinical trials brings some also great benefits for the study participants. First, by cutting down on travel and geographical limitations, a wider population can access the studies, which automatically increases the diversity in clinical research. But we’re not just making it easier to join. We’re also reducing the overall burden on the trial participants. If we simplify the data participants need to report, we make the whole experience less overwhelming. This means that more people can participate without the stress of long trips or complicated reporting, leading to a more inclusive and manageable trial experience for everyone involved.
How Replior incorporates digital endpoints?
Once we understood the benefits of measuring digital endpoints in clinical trials, it became clear that we had to also focus our efforts in integrating the highest technology into our clinical trials. That’s why we integrated a cutting-edge UV sensor into Trial Online data collection solutions.
This very small and light sensor monitors UVI, UVA, and UVB levels continuously and through Trial Online ePRO, the data is transmitted from the sensor to the participant’s smartphone in real time via Bluetooth, and then uploads this data to the Trial Online ePRO.
We soon put it to test by partnering with Almirall, the Spanish pharmaceutical company, for a phase IV dermatology study which required participants to report outcomes periodically and avoid sunlight or UV light exposure. The trial began enrollment in November 2022 and it is still ongoing but the results obtained in the initial analysis show a great adoption by the study participants who were much more engaged and compliant with the study.
Click here if you’d like to read the case-study and learn more details about our UV sensor and the results in this phase IV dermatology study.
