eCOA & ePRO: Improving Data Accuracy in Decentralized Clinical Trials

The benefits of decentralized clinical trials are becoming well known as many contract research organizations (CROs) and pharmaceutical companies increasingly adopt hybrid or fully-virtual models. Among these benefits are improved patient care, simplified patient experience, and increased data accuracy which results in a faster time-to-market.

A critical component of decentralized clinical trials is the use of electronic diaries, or e-diaries, to collect data directly from patients. In standard clinical trials, patient data is often collected in the form of paper diaries, which may not have the same level of data accuracy or convenience as e-diaries.

According to a study published in the U.S. National Library of Medicine, National Institutes of Health, the advantages of e-diaries include improved patient compliance. The study sites an observed reduction in behaviors such as parking lot compliance, which refers to patients who fill in the entire diary immediately before a study visit, and forward filling, which is when a patient enters data ahead of the scheduled time.

eCOA

eCOA refers to electronic clinical outcome assessment, which is a method of electronic data capture used in clinical trials. According to the U.S. Food and Drug Administration, a “clinical outcome assessment is a measure that describes or reflects how a patient feels, functions, or survives.”

For decentralized clinical trials, there are a number of eCOA measures used to determine how a treatment is working, and one of them is ePRO.

ePRO

Electronic patient-reported outcome, or ePRO, is the use of an electronic device to capture and transmit patient-provided data, including dosage and timing, side effects, and symptoms.

Paper methods of patient data collection have no way of controlling the quality or timeliness of data entry, making it impossible to avoid issues like skipped items, poor handwriting, and inappropriate responses. ePRO is able to deliver reliable data and higher patient protocol compliance.

Global clinical software companies provide unique eCOA and ePRO platforms that facilitate accurate data collection and regulatory compliance. 

Deploying Connected Devices

Mobile devices such as tablets, smartphones, and wearables can reduce human error and provide accurate, medical-grade biometrics for eCOA/ePRO data collection. Their use has been shown to improve the patient experience, which results in increased patient compliance.

Deploying connected devices for decentralized clinical trials across the globe is a daunting task — selecting the right technology partner can streamline the process of sourcing, securing, and connecting mobile devices that are used for patient data collection within clinical trials across the globe.

KORE powers connected health devices for decentralized clinical trials with a combination of wireless connectivity and network management, mobile device management, and deployment services — reducing time-to-market and total cost of ownership.

For a guide to the primary questions that you should be asking when considering decentralized clinical trials, download our eBook “Key Considerations for Clinical Trials.”