Electronic Patient – Reported Outcomes Software, commonly referred to as ePRO, is a classification of software used in clinical trials. The ePRO software helps patients to automatically respond to questions regarding their health status and also submit feedback on their clinical trial encounters.
Since the ePRO services are digital, the submission of patient-reported outcomes is done via electronic devices such as tablets and smartphones. Due to the centricity of patients during clinical research procedures, the application of patient-recorded outcomes is incorporated into the majority of clinical studies carried out today.
Traditionally, this process was entirely manual, where clinical care personnel and patients would fill in clinical data on paper. However, as technology has improved, clinical research data collection is becoming more paperless.
This has contributed to the popularity of ePRO implementation. Additionally, this software has undergone advancements, giving rise to AugmentedPRO.
What is Augmented ePRO?
With Augmented ePRO, you can integrate ePRO instruments with artificial intelligence, providing a consolidated platform for clinical appraisal. Augmented ePRO has been designed to deal with the irregularity and subjectiveness associated with conventional ePRO software.
Augmented ePRO, therefore, regulates and enhances the accuracy of clinical research results. With Augmented ePRO, all parties involved in clinical trials can instantaneously capture and transmit data either in the form of videos, audio, or photographs. Upon submission of this media, a professional with expertise in grading evaluates and rates each result.
What are the Benefits of Augmented ePRO?
Augmented ePRO is beneficial to all stakeholders who participate both directly and indirectly in clinical trials. Each stakeholder utilizes the software uniquely and therefore, the benefits derived are distinct for each party.
1. Clinical professionals
Credible clinicians use Augmented ePRO to access an intuitive interface, data quality assurance tools, and structured workflows. Experts are able to score outcomes skillfully and with minimal variance using these instruments.
2. Sponsors
As some clinical trials are backed by financiers, the ability to receive real-time data and results is essential for these sponsors. Augmented ePRO allows sponsors to access timely, detailed, and correct information, which expedites product development.
3. Patients
During virtual trials, patients are able to record and upload media such as photos using an enhanced ePRO. Since these tools are easily accessible and simple to use, the process is fast and convenient. In addition, the data collected and transmitted is of excellent quality. The software also ensures the safety of patients participating in trials that are not carried out in clinical settings.
How Does Augmented ePRO Safeguard Patients During Virtual Clinical Trials?
The implementation of Augmented ePRO in health systems guarantees the safety of patients. Investigative treatments can be harmful to patients if not correctly executed, and this is where Augmented ePRO comes in. To ensure the well-being of patients, their symptoms are closely observed and addressed by clinicians and sponsors around the clock.
The safety of patients is also enhanced through protocol compliance. For a successful trial, there are some procedures that patients need to adhere to. When entries are made on paper, it is difficult for clinicians to tell whether the entries were made accurately and on time. However, using Augmented ePRO, the rate of falsified entries is minimized, and data quality is enhanced.
Where is Augmented ePRO Implemented?
Even though Augmented ePRO is utilized across various medical fields, it is more commonly amalgamated with digital therapeutics. There are various types of software with clinical value that assist patients in managing medical conditions. Digital therapeutics utilize data-driven tools such as IoT and mobile devices to stimulate and monitor patients’ physiological changes.
How can you Incorporate ePRO into your Clinical Trial?
There are three major classifications of ePRO software. Some ePRO software provides SMS interventions, some are interactive voice response systems while others offer screen-based reporting solutions. Since each kind of ePRO software offers unique solutions, the first step is to determine the type of ePRO you would like to use for your trial.
This should then be followed by contacting several vendors offering your ePRO of choice, to enquire about the specification of the software they provide. Their feedback will be used to establish how their software will meet your needs. As you evaluate the suitability of each ePRO software, your patients should be the focal point.
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