Virtual research organisation (VRO) ObvioHealth has announced the introduction of Augmented ePRO for decentralised clinical trials (DCT).
The latest offering in tech-facilitated clinical trial services merges artificial intelligence-aided electronic patient-reported outcome (ePRO) instruments and a centralised clinical rating platform to provide accurate and consistent trial outcomes.
The multi-pronged tool, which is intended to address the subjectivity and variability that characterise ePRO, facilitates trial subjects to collect source data such as photos, audio or video on a real-time basis and upload it through the ObvioHealth app.
On uploading the media to the platform, a doctor and/or expert rater will evaluate and score each outcome.
The Clinical Oversight And Coordination Hub (COACH) site team offers virtual support to trial subjects as well as raters all along the process, to assure quality control from beginning to end.
Augmented ePRO provides benefits for all DCT stakeholders by using the convenience of ePRO and a centralised workflow for streamlined expert ratings.
Patients will be offered accessible image, audio and video recording tools that allow them to provide enhanced quality data with reduced effort.
Expert clinicians benefit from access to an intuitive interface, structured workflows and in-built quality controls, allowing them to deliver ratings in an efficient and less variable manner.
While the platform now enables precise endpoints, it also incorporates characteristics that can lead to new outcomes in the future.
Clinicians can also utilise the clinical notes, or annotation, feature within Augmented ePRO to explain why a rating was assigned. Furthermore, these notes can be used to programme automatic ratings over time.
The sponsors will also benefit from consistent, real-time and precise results, allowing quicker development of the product, its approval and marketing.
ObvioHealth co-founder and CEO Ivan Jarry said: “Both patients and expert clinical raters will benefit from this AI-assisted tech platform throughout the data collection and assessment processes.
“But, with an eye towards the future, the annotation feature is especially useful, allowing clinicians to easily capture nuances in patient ratings that can be used to train AI algorithms and lead to even better clinical rating processes in the future.”
Last October, ObvioHealth announced plans to start a DCT to assess Anatara Lifesciences’ Gastrointestinal ReProgramming (GaRP) product in Australia.