In clinical trials, proving efficacy of a therapy may require data from study participants, clinicians and remote monitoring devices in order to generate the required statistical signal to properly validate a clinical endpoint. Clinical data collection for trial participants often involves data capture from multiple stakeholders. These composite COA endpoints require a comprehensive solution to capture outcomes data.
Clinical Outcome Assessments (COA as the umbrella term) are administered and captured in different ways, as represented in the below image:
Consider the following participant journey to assess effectiveness of a novel pain management therapy:
Two brothers enroll in a study that captures pain scores and mobility data from participants daily and a Quality of Life score to be completed and compiled by a clinician at certain visits.
Visit One: Enrollment of two brothers (one is 4 years old and the other 18 years old).
At Home: 1-3 weeks of daily ePRO’s (mix of validated questionnaires and IP usage). The 18 year old will complete his own (ePRO), while his brother has his recorded by a caregiver (ObsRo).
Visit Two: In-Clinic ClinRo for both patients’ observed health state. Based on the results, one brother is issued a pedometer (PerfRo/RPM). The pedometer tracks key mobility and exercise data, viewable in TRYAL's (or a vendor partner’s) web portal.
In this instance, three different people and a monitoring device are needed to form a composite data set, all used to assess defined primary endpoints in the protocol. Each form of eCOA data capture has specific workflows and functionality requirements.
If a vendor does not have the capability or expertise to implement all eCOA data collection methods, sponsors and CRO’s must manage multiple vendors & solutions, instead of having functionality in a single platform.
TRYAL eCOA has, in a single platform, all the necessary functionality to capture outcome data from multiple stakeholders.
ePRO (electronic Patient-Reported Outcome) functionality allows participants to report their health status, symptoms, and treatment experiences, enabling real-time data collection on a device or via the web. The use of multiple engagement options through phone, tablet, or web, including text, chat, televisit, with native alerts and alarms increase compliance and task completion rates. TRYAL's user interface provides participants with a clear visual overview of current and upcoming required visits and assessments. Additionally, online and offline functionality supports data entry when connectivity is unavailable.
ClinRO (Clinician Reported Outcome) give clinicians access to review their assigned participants’ data, schedule of activities, and enter scheduled or unscheduled ClinRO assessments via TRYAL's eCOA portal.
ObsRO (Observer-Reported Outcome) functionality enables caregivers, parents or family members to complete observer based assessments regarding a participants health status or behavior. TRYAL ObsRO supports multiple caregivers/parents for a participant, including locked down rules & permissions.
PerfRO (Performance Outcomes Assessment) and remote participant monitoring functionality in TRYAL eCOA passively or actively communicates performance outcome data to support data requirements for study endpoints.
Tryal’s eCOA’s API forward architecture and third party integration experience allows sponsors to confidently use partners of their choice, knowing data is safely and reliably shared among key clinical systems.
Composite eCOA can provide a rich data set to support one or many endpoints of a clinical trial. When choosing an eCOA vendor, it's crucial to ensure their capabilities and expertise align with both your current study needs and future designs that require diverse data collection methods. TRYAL eCOA supports all primary modalities while adhering to the highest regulatory standards, guaranteeing high-quality data collection throughout the trial. Please contact a TRYAL representative to learn more about our eCOA offering.
Learn more about TRYAL eCOA at www.tryalclinical.com/ecoa or contact our team at info@tryalclinical.com.