The Advent of eCOAs/ePROs to Change the Future of Clinical Trial

‘Data’ is the most important output from the clinical trial. The efficacy and efficiency in data management paves the way for successful completion of a given clinical study with considerable savings in terms of time and money. Clinical outcome assessments (COAs) measure the status of patient’s health condition and share the information with the clinician. The COA measures are of four types; namely, patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measures; depending upon the source of information provider. Out of all the stated measure, PRO is most widely used during the clinical trials. The PRO questionnaire enables the patient (study subject) to report about his/her health condition.

The increase in dissemination of internet-connected systems both in clinical settings and in homes is instrumental in overcoming the prime challenge of PRO systems, that is, the complexity in converting paper-based surveys into immediately actionable information. The advent of ePROs (electronic patient-reported outcomes) is changing the future of clinical trials by reducing the overall time and money consumed in a clinical study. In today’s world where there is a constant conflict going on between the expenditure of time and cost, the ePRO systems have witnessed rapid adoption in the clinical studies. In addition, rising regulatory pressure to reduce the cost of drugs is further spurring the demand of eClinical solution market.

Currently holding the leading position in the eCOA market, PHT Corporation announced a 39% growth in bookings of its eCOA system in 2013 over 2012. Owing to the increasing adoption rate of electronic data collection methods, the company announced a 125% rise in the bookings of its eCOA systems during the first quarter of 2014 as compared to the same period in 2013. The company periodically hosts comprehensive educational events to increase the awareness about the application of ePROs and eClinical systems in clinical research programs; in addition to the advancements in its eClinical solutions. Besides PHT Corporation, other leading market participants such as CRF Health and eResearch Technology are also focusing towards the advancements in their eCOA solutions to meet the demand of clinical researches. CRF Health (listed in Deloitte’s Technology Fast 500, 2013 edition) announced (in July 2013) the innovative enhancements in its TrialMax eCOA solutions that offer improvement in the efficiency of collecting clinical outcome data directly from patients and sites. In October 2013, the company collaborated with Isis Outcomes and DHP (The Diabetes Health Profile) Research to launch the DHP-18 TrialMax edition. Eventually, increasing developments in eCOA systems are fuelling the adoption rate of these systems. Some of the key features that the researchers prefer to pay for include improved symptom identification and patient satisfaction, time saving, and increased accuracy of symptom assessment. In addition, customers need solutions that will be cost-efficient, reproducible and customizable.

As ePRO systems is on its path to take the clinical trials business by storm, it has to address the data security and privacy concerns. In addition, it involves the higher upfront costs to purchase and maintain the eCOA system and requires patient training on how to use the system. If the above stated concerns are addressed by the industry players while keeping in mind the customers’ expectations from a solution, then market is expected to grow much faster than the present rate.