Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are innovating the clinical trial industry. It’s time for Sponsors to embrace accurate and efficient real-time electronic data collection directly from patients, in the comfort of their day-to-day lifestyle, anywhere and at any time.
In this blog, we will provide an overview of eCOA and ePRO, how using them can increase the value of your clinical trial, and answer some frequently asked questions.
What are eCOA and ePRO?
eCOA (Electronic Clinical Outcome Assessments) allows the collection of electronic outcome assessment data directly from the patient with minimal interruption to daily routines.
ePRO (Electronic Patient Reported Outcomes) is one of the available electronic data capture (EDC) module options, where data is remotely gathered directly from the patient via a computer, tablet or smartphone in the comfort of their own environment.
These options reduce the need for patients to travel to a clinic or wait for a scheduled clinic telephone or video call, which improves the patient experience while reducing the site burden.
Patients provide data in real-time, and it’s as easy as sending a text message or opening a browser page. The real-time collection of data expedites access to accurate and safe patient-entered data.
How will ePRO add value to your Clinical Trial?
ePRO allows you to easily collect data directly from patients through daily diaries, logs, questionnaires, or any study-specific forms, improving accuracy, safety and integrity. Furthermore this also increases patient compliance while meeting regulatory requirements.
It is much more convenient for patients to record how they feel on their devices that are likely almost always with them, rather than writing responses in a physical journal, visiting a clinic, or having to carry two devices all day long to complete event-driven assessments.
MMS has the answers to your questions.
Does MMS provide support with licensed eCOAs?
MMS supports and assists Sponsors by proactively evaluating if an eCOA requires licensing and provides an estimated cost and timeline to obtain the license, and validation of the licensed eCOA.
Which systems does MMS use to provide eCOA/ePROs?
eCOA/ePRO is available through various platforms, depending on what the Sponsor requires for their specific trial design, for example Merative Clinical Development, Medrio, Medidate, etc. as well as the decentralized study platform, Thread.
Does MMS have pre-validated assessments in place?
The standard Library with pre-validated assessments already in place, improves costs and efficiency for Sponsors.
Is ePRO limited to a specific type of technology?
ePRO can be used on various devices, including smartphones, tablets, computers, etc.
Which devices can be used with ePRO?
ePRO solutions are web-based and can be used on various devices, including smartphones, tablets, computers, etc.
Can patients use their own devices?
In most cases patients can use their own devices. Bring your own device (BYOD) allows patients to seamlessly capture data and important symptoms on their own devices, improving patient experience as they are familiar and comfortable with their own devices. BYOD also removes the CRO burden of device provisioning.
What are the benefits of using ePRO in a Clinical Trial?
ePRO allows patients to actively report their symptoms in real-time, with accurate timestamping of data entries including audit trail for regulatory compliance. This improves data integrity and quality. ePRO reduces site burden and enhances recruitment, which is not limited to geographical locations and time constraints.
Can Sites monitor patients compliance?
ePRO compliance reports allow Sites to actively monitor patients ePRO compliance in real-time. ePRO data can enable electronic compliance notifications to sites, sponsors and patients using the MMS data analytics platform, Datacise.
Flexible ePRO study design options allow you to define study-specific requirements. Here are some things that ePRO/eCOA allows you to do:
User-friendly for patients:
- Create reporting habits that ensure accurate outcomes data from your patients in a timely manner.
- Provide training and support for patients, so that they can report their outcomes effectively.
- Define which pages will be used for electronic data collection according to your specific requirements
- Create assessment questions in multiple formats: free text fields, radio buttons, checkboxes, and more
Activate ePRO pages:
- Define when ePRO is activated on the participants’ devices according to study-specific milestones for specific patients
Frequency of data collection and delivery of ePRO pages:
- Define how frequently data will be collected from patients by setting up a specific time of day windows. For example, an Assessment Questionnaire can be available daily for 24 hours or a few days. Another option is a Morning Diary, which can be available starting at a specific time each morning.
- Get email notifications delivered to patients at defined time points as reminders that the ePRO Assessment Questionnaire or ePRO Diary is now available to complete on their devices.
- Deploy ePRO pages in their native language to ensure more accurate responses.
- Multilingual options support clinical development in later phase trials where global enrollment is critical.
By: Lizette Kilian, Data Team Lead and Sadanand Gurjar, Associate Manager of Clinical Data Management
If you would like support with eCOA, ePRO, decentralized clinical trials, or other data management projects, visit the MMS data management page or email email@example.com to be connected with an expert.