INTRODUCTION:
With the advent of technology and development, virtual clinical trials (VCTs) are gaining more and more popularity among patients and health care providers alike. It is because of the benefits like improved patient engagement, effective costs and improvement in data capturing that these trials provide. Virtual trials are being appreciated by both sides of the picture, since they allow easy access and autonomy to the patients, and also saves time of the health care professionals or the research unit staff.
Have you ever wondered how this complicated method of Virtual Trial works? What are the obstacles, and how may clinical studies be conducted virtually? Well, this post will help you understand about ePRO and eCOA, and their differences.
WHAT ARE CLINICAL TRIALS AND VIRTUAL CLINICAL TRIALS?
Clinical treatments are designed and tested on volunteers in research studies to determine their efficacy, potency, and safety. These clinical interventions may take the shape of medications, newer surgeries, and so on. Following successful trials, these studies assist researchers in developing more effective treatment options for the general population.
Clinical trials with digital health care technologies with remote participation of volunteers and research unit is called Virtual Clinical Trial. It is a much better version of traditional trials, saving time and providing better assessment within low cost.
USE OF eCOA AND ePRO IN Virtual clinical trials:
Virtual trials include two critical components: ePRO and eCOA. Electronic Clinical Outcome Assessment, commonly known as eCOA and electronic Patient Reported Outcomes, otherwise known as ePRO, are helpful in collecting, maintaining and assessing data about patient’s health, both before and after the therapy, and the course of treatment. These tools indicate safety and efficiency of the treatment and medications.
WHAT IS eCOA AND ePRO?
ePRO and eCOA are two methods for collecting data from research study volunteers.
Electronic Clinical Outcome Assessment (eCOA):
This instrument, which is popular among CROs and funders, facilitates in gathering data on participants’ health state, illness development, or prognosis via electrical methods. Smartphone apps, wearable bands, and other gadgets may be included.
Benefits of eCOA:
It provides autonomy to the participants, full access to report at any time or place. It ensures patient treatment adherence and leaves no chance of missed surveys. Data collected through eCOA is more efficiently collected, trustworthy, and timely than data obtained through traditional techniques. It speeds up data collections and ensures quality data analyses.
Electronic Patient Reported Outcomes (ePRO):
Participants monitor and record their own health state and electronically report their symptoms and health status using digital tools, polls, surveys, and so on.
Advantages of ePRO:
ePRO systems, as part of the eCOA system, make clinical trial processes less stressful for both patients and researchers. Data might be acquired in person or remotely. Moreover, these are cost effective ways.
DIFFERENCE BETWEEN EPRO AND ECOA:
eCOA collects data using ePRO or ePRO is essentially a kind of eCOA. Both systems work together to give a more accurate evaluation of participants’ health and contentment, resulting in better study findings and a better prediction. Data reported by volunteers is remotely transferred to research authorities and health care professionals via ePRO.
Both assessment aspects enable greater enrolment and engagement of study participants, as well as retention of their knowledge for better outcomes in developing potential therapeutic targets for the general population. VCT participants may simply complete survey and feedback activities on their health status and satisfaction from any distant place. Furthermore, because eCOA and ePRO provide survey forms that require minimal knowledge from participants, these platforms make VCT data gathering easier.
When it comes to evaluation of outcomes, ePRO along with eCOA systems allow participants to work from any location and submit their health metrics, giving them more possibilities.
For health care workers and research study teams, it provides real time patient surveillance. Improved data quality yields actionable information that can be viewed, accessed and studied with less deployment time. Enhanced data quality helps them with decision making regarding treatment efficacy, possible side effects and dosage.
Other advantages of using eCOA and ePRO in clinical trials include little to no error that may occur due to unreadable handwriting, poor sorting of data or misplaced data, greater teamwork experience with no communication block, and enhanced reporting. Using ePRO patients report their symptoms and views regarding the intervention made and eCOA itself assesses them using digital technology measures. The outcome of these efficient trials is enhanced prognosis, wider therapeutic options for treating patients with different histories, and implementation of treatment trial that has more success rate.
CONCLUSION:
In clinical research studies, Electronic Clinical Outcome Assessment, or eCOA and electronic Patient Reported Outcomes, known as ePRO forms integral part of modernized clinical trials conducted virtually or in real. They provide better assessment of research participant’s health condition than those conventional means, eradicating human errors leading to the implementation of better treatment strategies and more options.
