Consumer health clinical trials collect various types of data depending on the product under investigation. Contrasting traditional drug studies, they tend to focus on obtaining information related to user experience and satisfaction, perceived efficacy, user demographics, compliance, and other qualitative variables in order to make specific health claims. Because of this, much of these findings can be captured simply through ePRO.

What is ePRO?

ePRO, or Electronic Patient Reported Outcomes, is information patients self-report in clinical trials electronically through a web-based application or website. The data collected through the ePRO system may pertain to symptoms, side effects, adherence to using a product, lifestyle, and more depending on endpoints being measured in the trial. For example, a study for a cosmetic or skincare product may require participants to submit photos documenting change in appearance for remote medical evaluation.

Benefits of ePRO

There are numerous benefits to incorporating ePRO technology into your consumer health research, including: 

Streamlined Data Collection

ePRO systems enable an easy solution for participants to record data electronically in-real time from their personal smartphones, tablets, and computers. These technologies timestamp when entries are made, confirming that  the information was submitted within the appropriate window of time. 

This real-time data capture ensures that information is immediately available for analysis, reducing the lag time between data collection and review. As a result, researchers can make more timely decisions pertaining to the use of the consumer health intervention and study participation.

Enhanced Data Accuracy and Reliability

Traditional paper-based data collection methods present a higher risk of participants not providing information completely or in a timely manner, resulting in potential errors from recall. In addition, paper forms can be misread, lost, or incorrectly filled out. All of these scenarios can result in data inaccuracies that can compromise the integrity of a consumer health trial. 

ePRO technology eliminates these hurdles by enabling participants to report their health outcomes in real-time. Push notifications or personalized text message reminders can be implemented to prompt timely reporting of data, and the platform can be configured to not allow responses out of designated windows for entry. With built-in validation checks and user-friendly interfaces, they also guide participants to provide complete and accurate information. This not only improves data reliability but also reduces the need for data cleaning, saving valuable time and resources.

Improved Participant Engagement and Compliance

Engaging and retaining participants is a constant challenge in clinical trials. ePRO systems overcome this by offering a more convenient and user-friendly way to conveniently report outcomes pertaining to their experience using a consumer health product using their own device. This flexibility often leads to higher compliance rates, as participants are more likely to complete assessments when it fits into their daily routines. 

Mentioned previously, reminders and alerts can be integrated into ePRO systems to prompt participants, further improving compliance and adherence to the investigational product. At Lindus Health, we’ve seen significant success in ensuring ePRO completion with automated text messages coming from study coordinators to remind participants to use an investigational product and complete data entry.

Real-Time Data Monitoring and Feedback

ePRO enables real-time monitoring of patient-reported outcomes, allowing researchers to track progress and identify any issues promptly. This immediate access to data can help detect trends or adverse events early, enabling quicker interventions and adjustments to the study protocol if necessary. For example, if a participant using a consumer health product experiences a negative side effect, they can document it in a timely manner and medical monitors can then distinguish the severity and decide how or if their participation in the trial should continue.Real-time feedback also empowers participants, providing them with insights into their own health data and fostering a sense of involvement in the trial.

Cost-Effectiveness and Resource Optimization

Implementing ePRO systems can lead to significant cost savings. The reduction in paper use, printing, shipping, and manual data entry translates to lower operational costs in addition to less logistical variables to consider such as vendor coordination and delays in shipping.

Moreover, the streamlined data collection and analysis processes mean that studies can be conducted more efficiently, potentially reducing the overall duration of the trial. For example, providing insights pertaining to experience, side effects, quality of life and even photos via ePRO has the potential to eliminate some, if not all, in-person study visits in consumer health trials, eliminating the need to pay physical sites and reimburse travel expenses. This cost-effective, lean approach allows for a more efficient allocation of resources towards other critical aspects of the research.

Facilitating Remote and Decentralized Trials

The rise of decentralized clinical trials, especially in the context of the COVID-19 pandemic, has emphasized the importance of remote data collection methods. ePRO is an excellent solution for these study models, as they allow participants to provide relevant trial data to research teams without the burdensome travel to a physical site or lengthy study visit. This not only expands the geographical reach of clinical trials but also makes participation more accessible to a diverse population, enhancing the generalizability of the study findings.

Many consumer health studies have the ability to take on a fully virtual or hybrid study model due to the nature of the data collected in these trials. They tend to focus on collecting more subjective information with the consumer health product rather than biometric data, mitigating the need or reducing the frequency of in-person medical evaluation. 

Conclusion

ePRO systems are revolutionizing data collection in consumer health clinical trials, offering a multitude of benefits that enhance efficiency, accuracy, and participant engagement. By streamlining the data collection process, improving data reliability, and facilitating real-time monitoring, ePRO has raised a bar for consumer health clinical research.

Interested in learning how ePRO technology can be tailored to your study? Lindus Health has extensive experience in developing these solutions to collect the necessary data to obtain clinical validation for a variety of consumer health products. Book a meeting to learn more.