The “E’s” of eClinical Software: Understanding and defining technology elements of decentralized trials
Decentralized clinical trials (DCTs) have continuously evolved since their rapid adoption in 2020 and as the implementation of DCTs continues to rise, the need for more universal alignment on processes and definitions has become more prominent than ever.
In addition to the industry-wide need to unify on the definition of general terms, there is also the need to do so on a more micro level, specifically with technological or software terminology as these terms are widely used across all clinical trial stakeholders including DCT vendors, physicians, sponsors, sites, and even patients. We break down some of the critical technological DCT terms below as it relates to clinical trial software holistically in addition to components of a decentralized clinical trial platform.
The Decentralized Trials & Research Alliance (DTRA) has recently released a glossary defining many of the commonly used terms in the decentralized clinical research space. Some of these definitions will be utilized throughout this article. Furthermore, the FDA continues to release updated guidelines and recommendations for best practices and terminologies within the DCT industry.
eClinical Software Platform
eClinical is used to describe technology or information systems that can be used to plan, execute, manage, sort, analyze or report any electronic trial data. An eClinical software platform is a collection of most if not all the “E’s” including eConsent, ePROs, EDCs, eSources, eCOA, and more. An eCinical software platform typically offers a wide range of technology and digital services that can help design a trial that is as efficient and successful as possible using these “E’s” to streamline processes, engage patients, and collect necessary data at all crucial points in a study.
eConsent, or electronic informed consent, is a digital process that allows potential trial participants to receive all necessary information and educational resources on a study and confirm their understanding and acknowledgment of what their participation in a trial means. The recently released Decentralized Trials & Research Alliance (DTRA) glossary defines eConsent as an “electronic form that may include multimedia components such as images, audio, videos, diagrams and a digital signature to aid the collection of the informed consent of a participant.” eConsent software is simply the protocol-compliant digital software or platform technology used to deliver eConsent to patients.
eConsent, however, can take serval forms including remote vs. on-site consent in which technology can be used to administer informed consent, but patients may still be required to fill it out in a site office. The type of eConsent utilized can change on a study-to-study basis. Whether it be on an in-person site iPad, or remotely from a patient’s mobile device, eConsent is often amendable to the needs and requirements of a study. Furthermore, eConsent can be configured for one-party, pediatric, and legally authorized representatives (LARs) to allow for the consent methods to be adjusted as necessary based on the participant pool.
Electronic Data Capture (EDC)
EDC, or electronic data capture, is the process of digitally sorting and storing patient data that has been collected electronically. This patient data comes from specific means of capture, such as ePROs, wearables, electronic medical records (EMRs), etc., which can be considered the source of that data.
eClinical EDC or eClinical electronic data capture refers to the data collected through the processes and systems in place while running a clinical trial. An eClinical suite simply refers to the specific eClinical tools used to run clinical trials, such as a DCT platform.
According to the FDA, source data includes “all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation used for reconstructing and evaluating the investigation.” In a more modern sense, eSource would be the electronic means of data collection.
eSource is the digital or electronic sources used to collect patient data and information for a study. Specifically, it is a way in which sites can capture source data directly through digital means. eSources can include wearables, patient monitoring surveys, med device data, etc.
What is the difference between eSource and EDC?
EDCs are more holistic collections from software and eSources which collect a wide range of data from multiple sources. eSources are a means of data collection that feeds into the EDC along with several other types of data collection methods. EDC typically acts as the final repository for all relevant trial data which can ultimately be used for study submission.
ePRO vs eCOA
ePRO (electronic patient-reported outcomes) is defined by the DTRA glossary as, “a health outcome directly reported by the participant who experienced it and collected by electronic methods.” ePRO software can include various technologies that are capable of capturing patient-reported data, such as patient surveys administered on care platforms.
What does eCOA stand for in clinical trials?
eCOA, or electronic clinical outcomes assessment, is an “electronic capture of a measure that describes or reflects how a participant feels, functions or survives during a clinical trial,” according to the DTRA glossary. eCOA technology and/or eCOA software are the means by which electronic clinical outcomes assessments are distributed and collected. Having a sophisticated eCOA platform that is capable of executing a wide variety of assessments can be crucial to the success of a study. The right full-service DCT vendor can typically equip studies with the proper eCOA solutions they need.
So, what is the difference between eCOA and ePRO?
Although the definitions for eCOA and ePRO may seem similar, ePROs are a type of eCOA. The DTRA glossary mentions ePRO in a list of examples for eCOAs stating, the “types of eCOAs include: Electronic Clinician-reported outcome (eClinRO) measures Electronic patient-reported outcome (ePRO) measures Electronic Observer-reported outcome (eObsRO) measures Electronic Performance outcome (ePerfO) measures.”
Why is eCOA so important in clinical research?
eCOA in clinical research produces crucial data specifically around the patient, staff, and clinician experience within a clinical trial while also offering important insights on patient health, wellness, and any changes they may see through the study. Not only is this type of data crucial for the future of clinical trial designs, it can also alert to immediate flaws in current study execution or technology. Clinical eCOAs collect feedback from those actually participating in the study itself. Allowing sponsors to see how stakeholders and particularly patients are experiencing as they progress through a trial.
When it comes to defining and utilizing common technological terms in the DCT industry as it relates to platforms and digital services, it is imperative that there is a universal understanding. These terms are not only used by DCT stakeholders but providers, sites, sponsors, and patients as well, so, there needs to be a clear and concise comprehension of these terms. Defining commonly used terminology and remaining consistent with use cases can help ensure that all parties within a clinical trial are working together, unified, and on the same page.
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