The success of any clinical research trial is inextricably linked to the accuracy and quality of the data collected from participants. When testing the efficacy of a new medication, medical device, or any other medical intervention, researchers need accurate and timely clinical trial data. In recent years, there has been a shift towards ePro (electronic patient-reported outcomes) over more traditional forms of data collection like questionnaires and in-person interviews. This article will explain ePRO Clinical Trials as a concept, its benefits, and how it can be implemented in clinical studies.
What is ePro in clinical trials?
ePro is a data collection system that relies on patients using digital devices to report on the effects of whichever medication, medical device, or medical procedure is being tested in a clinical trial. The researchers could provide the device to be used, or the patients could just install an app on their existing smart devices. Responses include information regarding pain, adverse effects, their overall health-related quality of life, and whichever data is required by the clinical trial protocols.
It is important to note that ePro as a concept has been around for more than 2 decades. It started getting mainstream acceptance in the mid-2000s as smart mobile devices became commonplace in almost every household. But as anyone with experience in the medical field knows, there is a lot of inertia when it comes to adopting new technology in clinical practice.
The 2019/2020 COVID pandemic was an accelerator for ePro adoption. This is because the technology facilitated decentralized trials where patients could participate from their homes and with limited contact between researchers and patients due to COVID restrictions. As of 2021, it is estimated that up to 25% of all clinical studies will use electronic patient reporting.
The Benefits of ePro
It gives better data
A patient’s reported outcomes are not as restrictive as questionnaires or interviews. It allows patients to initiate the reporting process, where they report pain, symptomatic AEs (adverse events), and other symptoms in real-time as they experience them. A systematic review has shown that this leads to the collected pro data having better statistical significance.
It allows for decentralized clinical trials
Decentralized clinical trials don’t require patients to attend a single site while living their normal lives. This has many advantages; for one, it is much cheaper to make a trial decentralized rather than handle the logistics of housing all participants. Another benefit is that it also allows studies involving participants over a large geographical area, even on a global scale. Also, patients see how the intervention being tested affects their everyday lives.
ePro is cheaper
With ePro, there are reduced manpower needs for data collection, and transcribing the data from questionnaires/interviews for analysis. Patients record their experiences and the data is transmitted to the research center’s electronic health record cloud servers. If the ePro system utilizes an app on the patient’s device, then there aren’t any hardware purchasing costs, making it more affordable.
It is the patient-preferred method
Case studies show that patients participating in clinical trials overwhelmingly prefer using pro measures over ‘traditional’ data collection instruments. This is because of the convenience offered by digital reporting as well as the overall population’s familiarity with technology. Even the elderly demographic that is considered non-tech-savvy knows how to operate a basic smartphone or tablet and prefers it over paper questionnaires.
Implementing an ePro system
Understanding your needs
The first step in implementing any technological solution is understanding your organizational needs. Are you doing a one-off clinical trial or do you want a system that can be adapted for multiple trials over time? Will you provide the device or will you take the app route with a patient using their own mobile device? What is your budget? Understanding your needs and budget makes it easier to shop around and consider the offerings from ePro vendors from a position of knowledge.
Organize for training
No matter how ‘easy-to-use’ your system is, always ensure that everybody using it is trained on how to make the most of the ePro tech. This includes the patients, the medical staff, and any administrative personnel that are involved in the clinical trial. At the very least, the staff members interacting with the patients should be able to help them out with basic troubleshooting and explaining the functionality of the system.
Collect user experience data for improvement
There is always room for improvement, and you should collect user experience data from patients and staff to understand how the system can be improved. Patient experience data collection can be integrated with their health outcomes reporting. Apart from self-reporting, impact case studies and clinical reviews can shed more light on the user experience both within the patient population and staff members.
Kyle Noble is the visionary founder and owner of DAPLA.org, a leading platform dedicated to exploring the enigmatic realms of dark plasma theory. With a profound expertise in theoretical particle physics, Kyle has carved a niche in the scientific community by delving into the fluid-like behavior of dark plasma, a self-interacting form of dark matter.