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Keeping eCOAs Off the Critical Path – Key Considerations

The prevalence of decentralised clinical trials, rising demand for preventive healthcare solutions, a market driven by the need for more and better-quality data and the importance of patient-centricity in medical practices have led to a compound annual growth in the use of connected digital devices. The Covid-19 pandemic has been instrumental in proposing innovations to existing site-based trial designs. Remote patient monitoring and reporting services provided by digital health technologies can expand and diversify the study cohort for clinical trials, benefitting a much larger cross-section of the global population. It can not only improve the efficiency of clinical trials but also contribute towards long-term cost savings.

These developments have also led to an increase in the use of electronic Clinical Outcome Assessments (eCOAs). Digital devices like smartphones, tablets, wearables and web-based platforms are increasingly being used to measure the impact of a disease and/or treatment on patients’ quality of life and are an important way we can capture the patient’s voice in a clinical trial. These assessments monitor the patient’s health by analysing several parameters such as any symptoms of diseases, adverse events, quality of life or other health-related outcomes. The eCOA system consists of the devices used for data collection, specialised eCOA software installed in these devices for collecting the data or access to web-based eCOA platforms and a centralised database or server to store, manage and analyse the data securely.

eCOA solutions come with several benefits in a study trial set-up such as:

• Interface: The digital devices offer interactive, user-friendly and engaging interfaces as opposed to paper based questionnaires, leading to increased patient engagement and data completion rates. eCOAs support the delivery of automatic notifications, reminders and alerts that can improve patient compliance.

• Analytics: eCOAs are ideal for real-time data capture, which can help in monitoring and reviewing data in real-time and on a continuous basis. This allows researchers and healthcare professionals to access real-time patient-reported data for analysis and decision-making. They also support the collection of patient-reported outcomes remotely and enforcing a time limit for filling up electronic questionnaires that helps in avoiding the “parking lot effect,” allowing timely collection of patient data. Electronic assessment methods reduce the possibility of data entry and transcription errors ensuring accuracy and reliability of collected data.

• Profitability: eCOAs reduce administrative burden, data entry and paper related costs. They eliminate the need for data transcription from paper to electronic and streamline data collection, management and analysis processes, improving trial efficiency and reducing overall study timelines.