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Electronic clinical outcome assessments (eCOA) and electronic data capture (EDC) are two types of technology that have transformed the way clinical trials are conducted. Both eCOA and EDC technologies are designed to streamline data collection and management, reduce errors, and improve data quality. In recent years, there has been a growing interest in the use of eCOA and EDC for hybrid trials and decentralized clinical trials (DCTs), which have emerged as a popular alternative to traditional clinical trials.
What is a Decentralized Clinical Trials (DCT)?
Decentralized Clinical Trials (DCT) are a type of clinical trial that utilizes technology to enable remote monitoring and data collection. Clinical trials are research studies that test new medical treatments or devices. These trials test the safety and effectiveness of the new therapy. In a DCT, patient data is collected completely remotely, either via mobile devices, wearables, or other data collection technologies. This allows patients to participate in clinical trials from the comfort of their own homes, eliminating the need for site visits. Clinical trials have traditionally only been conducted at a testing site. Study participants were required to visit a particular location, a hospital or laboratory, to collect data. The ability to travel to the test site was an additional factor of consideration for participants and often limited the applicant pool. DCTs have become increasingly popular in recent years, particularly in the wake of the COVID-19 pandemic, which disrupted traditional clinical trial operations.
What is a hybrid trial?
Hybrid trials are a type of clinical trial that combines traditional site-based clinical research with DCT elements. In a hybrid trial, some aspects of the clinical trial are conducted at the clinical site, while others are conducted remotely. The goal of a hybrid trial is to leverage technology to reduce the burden on patients, increase patient retention, and collect data in a more efficient manner. Hybrid trials can be particularly useful for rare diseases, where patient recruitment and retention can be challenging. However, they also present new challenges, particularly when it comes to data collection and management.
EDC and eCOA what they are and how can they be used?
Electronic Data Capture (EDC) and Electronic Clinical Outcome Assessments (eCOA) can be used in hybrid trials and DCTs to improve data quality and reduce the burden on patients. EDC technology enables the collection and management of clinical trial data electronically, which can be particularly useful for studies that involve large amounts of data. EDC systems can be used to capture a range of data, including patient consent, clinical data, laboratory data, and safety data. EDC technology can help to reduce the risk of data errors or inconsistencies by eliminating the need for manual data entry. By using EDC, clinical trial sponsors can ensure that data is captured accurately and efficiently. It can even produce analytics and reports necessary for trial conclusion submission.
eCOA is a technology that enables the capture of clinical trial data directly from patients using electronic devices such as smartphones, tablets, or laptops. eCOA can be used to collect a range of data, including patient-reported outcomes (PROs). PROs are a critical component of many clinical trials as they provide valuable insights into a patient’s quality of life, symptoms, and overall well-being. Traditionally, PROs were collected using paper-based questionnaires, which can be time-consuming, error-prone, and difficult to manage. eCOA technology eliminates many of these challenges by enabling patients to complete questionnaires electronically, either on their own devices or through a dedicated study portal. Patients can complete eCOA assessments from their own homes, and the data can be transmitted securely to the clinical trial database. One of the key advantages of eCOA technology is that it allows for real-time data capture, which can be particularly useful for hybrid trials or DCTs. Real-time data capture means that data is collected as soon as it is entered into the system, allowing for immediate monitoring and analysis. This can help to identify potential issues or trends early on, enabling researchers to take proactive measures to address them.
When using eCOA and EDC technology for hybrid trials or DCTs, it is important to ensure that the technology is properly validated and compliant with regulatory requirements. Both eCOA and EDC technology are subject to regulatory requirements, such as the FDA’s 21 CFR Part 11, which outlines the requirements for electronic records and signatures. It is important to ensure that the technology is validated in accordance with these requirements to ensure that study data is accurate, reliable, and secure.
Another important consideration when using eCOA and EDC technology for hybrid trials or DCTs is the need for training and support. Patients and site staff will need to be trained in how to use the technology effectively, and support will need to be provided to ensure that any issues are resolved quickly. It is important to have a dedicated support team in place to ensure that any issues are addressed promptly and efficiently.
EvidentIQ offers EDC and eCOA solutions that meet these needs and can be tailored to specific trials to address their unique requirements. EvidentIQ’s EDC software can be customized for different profiles including academics and medical device researchers. The eCOA feature is both regulatory compliant and also user-friendly. The eCOA technology guides proper protocol execution while automatically validating data upon entry. It is great for users with all levels of research experience which saves on training time. Clinicians can enter digital data without the need to transcribe clinical data from paper forms and charts. The EvidentIQ EDC and eCOA solution will help collect, manage, and store electronic data for your next hybrid or decentralized clinical trial.
Sources:
https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies
https://www.obviohealth.com/resources/hybrid-clinical-trials-the-shift-to-decentralization
https://onlinecrf.com/important-requirement.html
https://www.evidentiq.com/resources/ready-for-remote-ecoa-and-edc/
https://www.evidentiq.com/resources/how-to-choose-the-best-edc-software-for-your-company/
