How eCOAs can benefit clinical trials
Clinical outcome assessments (COAs) are designed to enhance the development of new treatments by facilitating a greater understanding of how a patient functions, feels, and survives. Historically, COAs have been completed with paper and pencil, and typically required participants to travel onsite.
Electronic clinical outcome assessments (eCOAs), however, can be recorded either onsite or remotely on an electronic device, such as a smartphone, tablet, laptop, or desktop computer, which means that data can now be reported at defined time points outside of the clinical environment. This gives researchers a more well-rounded understanding of a treatment’s value and adds new data to better assess health related quality of life impacts that patients often highly value
Read on to learn how the built-in flexibility and freedom of eCOAs can enhance many aspects of a clinical trial.
Although researchers were already thinking more about the use of remote assessment in clinical trials, the COVID-19 pandemic sped this process up. Patients already enrolled in trials could no longer attend site visits and trials that were about to start needed to plan for assessments not being carried out at in-person site visits.
In response, the FDA issued guidance for conducting trials virtually, which was enthusiastically embraced by the industry, leading to the widespread adoption of decentralized clinical trials involving telehealth, remote data capture, and other virtual solutions.
As we’ve written about before, there are four types of COAs: Patient reported outcomes (PRO), Clinician reported outcomes (ClinRo), Observer reported outcomes (ObsRo), and Performance outcomes (PerfO). When any of these COAs are captured electronically, either onsite or remotely, they are known as eCOAs.
There are different considerations for remote data capture depending on the type of COA, but the promise of these alternatives to the traditional paper and pencil, on site clinical trials are exciting, as they don’t require participants to physically travel to a clinic.
Why don’t participants need to go into the clinic to capture eCOAs?
- We can measure PROs and ObsROs outside of the clinical environment using electronic devices that ensure the data is captured at the right time (as specified in the protocol)
- We can create electronic versions of PerfOs that were traditionally done on paper, or use the sensors in devices (such as smartphones) to capture this type of data
- We can use Televisits to carry out some types of eClinROs (or ClinROs), or use mobile health for home health professionals to complete at the patient’s home
What are the clear benefits to using eCOAs in a clinical trial?
There are countless benefits that eCOAs can provide a clinical trial when implemented correctly. Just a few of these benefits include:
- Avoiding missing, ambiguous, or conflicting data
- Eliminating time consuming and error-prone, site-based manual data entry
- Reduced site and CRO burden
- Rapid identification of non-compliance and ability to put a remedy in place
- Automatic calculations and reports on screening criteria or other decision points
- Reduced participant burden and increased accessibility
- Reduced travel times and less time off work (as participants are often very ill, reducing this burden is critical)
- Automatic reminders so participants don’t have to rely on memory
- Eliminating the need for paper copies of home-based diaries
We must also remember that the data obtained from clinical trials is going to be scrutinized by regulatory agencies to determine if that data supports the approval of a new treatment, and so we must ensure the highest quality data possible. Regulatory agencies, including the FDA and EMA, have recognized the benefits that eCOAs provide, such as improved data integrity, and have expressed support for their use. Plus, on account of that improved data integrity, eCOAs can help ensure ALCOA compliance.
Ready to get started with eCOAs? Contact Medable today, your expert eCOA clinical trial partner.