Electronic Clinical Outcome Assessments (eCOA) employs technology such as smartphones, tablets, and personal computers to allow patients, clinicians, and their caregivers to directly report outcomes.eCOA produces highly accurate data that allows for a better understanding of the patient experience in clinical trials and ultimately helps simplify the path to approval. Regulators demand accurate data and eCOA meets the ALCOA standard:
- Attributable: Can the data be linked to its source? It should be attributable to the subject who observed and recorded the data, as well as traceable to the source of the data itself. eCOA makes it easier to attribute data to specific subjects via unique PIN codes, data and time stamps, and audit trails.
- Legible: Is it easy to read? With eCOA, you no longer lose data because of bad penmanship or the misinterpretation of patient and clinician handwriting. Typed entries and standardized response options as well as code list selections support improved legibility.
- Contemporaneous: Has the data been recorded at the time the observation was made? Reminders and alarms prompt subjects to enter data at the right time. Also, study teams are alerted if data is missing to ensure compliance. This all helps to control or eliminate retrospective data entry.
- Original: Is the data the first and most accurate and reliable recording of data? PRO data captured directly from the subject in electronic form eliminates the need for Source Data Verification.
- Accurate: Does the final report accurately describe the study conduct and reported results? eCOA makes it easy to audit data for errors and alterations, improving the integrity of every trial. Built-in logic and real-time edit checks prevent incomplete and inconsistent data entries.
Advantages of eCOA
Patients are used to carrying one or more electronic devices wherever they go. By collecting COA data on these familiar electronic devices, you increase your chances of gathering complete, accurate and timely information in your clinical trial.There are four types of clinical outcome assessments (COAs) that are used to provide evidence of a treatment benefit and that are typically used to collect data to support claims made to the regulators when seeking approval. They are:
- Patient-reported outcomes (PRO). A report of the status of a patient’s health condition that comes directly from the patient, i.e. symptoms only known to the patient. Examples include pain intensity, bowel movements, psychological symptoms such as anxiety or depression, and general quality of life measures such as how the disease impacts a patient’s daily life.
- Clinician-reported outcomes (ClinRO). According to the FDA, a ClinRO is based on a report that comes from a trained healthcare professional after observation of a patient’s health condition. Examples of ClinROs include a patient’s tumor size, range of motion, eczema severity, or dementia assessments.
- Observer-reported outcomes (ObsRO). When data is reported by an observer who is not a healthcare professional, such as a patient’s parent, caregiver or spouse, it is an ObsRO. Examples of an ObsRO include reporting infant’s crying or vomiting episodes.
- Performance outcomes (PerfO). PerfO is a measurement based on a task performed by a patient according to instructions that are administered by a health care professional. Examples include walking tests, tests of memory, or digit symbol substitution tests.
A Smarter Way of Doing Things
eCOA helps you collect timely, reliable and comprehensive data during every trial phase. Better data means a more accurate interpretation of study results and a deeper understanding of your patients.When trying to define eCOA, it’s important to consider its biggest advantage: its intelligence. With eCOA, you can:
- Receive alerts when patients take irregular medication dosages, improving patient safety and compliance.
- Collect and compare data across multiple devices, thanks to the power of the cloud.
- Integrate eCOA data with objective data from other devices, including glucometers, activity monitors, and peak flow meters.
- Visualize data using graphs, charts, and other tools so you can spot trends and make quick adjustments as the clinical trial progresses.
- Maintain a clear, consistent audit trail that demonstrates the quality and compliance of your clinical trials.
Whether you’re collecting instantaneous data through a patient’s smartphone or reporting intermittent data over longer periods of time via the web, eCOA is convenient, accurate, and most of all, it’s smart. You get cleaner data and deeper insights — with a lot less work and a significantly reduced margin for error.
What Is eCOA From CRF Health?
Ready to implement eCOA for the first time or need to rethink your current eCOA strategy to drive more value from the technology? CRF Health has a range of solutions for developing, collecting and managing eCOA data
- TrialStudio™: Great design is essential to a successful clinical trial because intuitive, user-friendly eCOA solutions drive high compliance rates and clean, accurate data. CRF Health’s design process is powered by TrialStudio™, and is collaborative, interactive, and agile. Instead of waiting weeks, your team receives a working prototype as early as our first meeting. We create your eCOA questionnaires quickly, make changes with ease and provide peace of mind through transparency into the entire process.
- TrialMax™ Collectors: : CRF Health offers a range of eCOA modalities including smartphones (TrialMax Touch®), tablets (TrialMax Slate®), app-based BYOD solution (TrialMax App®), and web-based BYOD solution (TrialMax Web®). Successful eCOA implementation involves study teams and eCOA providers working together to consider all options against the unique needs of individual trials.
- TrialManager™: : Monitor and manage your eCOA clinical trial data in real-time with TrialManager™. CRF Health’s online portal makes it easy to instantly explore and review data collected from any TrialMax® modality. Discover meaningful insights and drive smarter decisions with next-generation data visualization reporting tools.
Implement eCOA for Your Next Trials
Learn how eCOA can improve the clinical trial experience for all stakeholders while ensuring the highest quality and most accurate data collection. Contact us