With electronic Clinical Outcome Assessments (eCOA) continuing to deliver the highest patient compliance and improved data quality in clinical trials, it’s mind-boggling that nearly half of today’s studies that collect patient outcome data do so using primarily paper solutions. Perhaps the biggest myth behind this phenomenon is the misunderstanding that eCOA is only suitable for large, global companies.
But, this is simply not true. In fact, every day hundreds of small pharma, biotechs and CROs are benefitting from using eCOA in their clinical trials.
Here, we demystify some other misperceptions and present how all sponsors can benefit from using eCOA in clinical trials, regardless of their size.
Myth: Regulators won’t accept eCOA data
False! eCOA is routinely accepted by international regulators and has been for many years. Take the FDA’s 2011 approval of Incyte’s myelofibrosis treatment, Jakafi®. FDA’s Dr. Richard Pazdur commented that one of the key factors that led to Jakafi’s approval was that Incyte ensured almost complete data collection on the PRO endpoint with the aid of an electronic diary; without it, Jakafi wouldn’t have been eligible for a full approval.2
For years, global and regional regulatory authorities have published guidances and reflection papers on eSource, ePRO, and eCOA outlining their requirements regarding clinical trial data collection ─ most of which cannot be met with paper processes. For example, the FDA’s 2009 PRO guidance states, “[W]e plan to review the clinical trial protocol to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected.”3 Unlike paper diaries, ePRO meets this regulatory expectation by improving patient protocol compliance and digitally documenting the date/time of their diary entries (Figure 1).
Myth: eCOA is too expensive
Not true! There’s an outdated notion that paper diaries are less expensive than eCOA in clinical trials. Today, that’s simply not the case. The cost of poor quality data gleaned from paper data collection and transposition can far outweigh the cost of eCOA data collection.
And, real-time eCOA data capture can translate into substantial clinical research efficiencies. McKenzie et. al realized significant potential cost savings when examining the results of a Phase III overactive bladder study using eCOA compared to a similar study using paper COA. By reducing error variance, eCOA produced more sensitive study results, which could have reduced the study sample size by nearly 50%, representing a significant impact on drug development timelines and costs.5
Additionally, eCOA overcomes the many hidden costs of paper COA – errors inherent in manual data entry can force the sponsor’s study team to spend countless hours reconciling data before manually entering them into a database. So, when accurately accounted for, labor costs for paper-based COA can actually eclipse the costs anticipated with eCOA usage.
Myth: eCOA is too hard to implement
Definitely untrue! eCOA implementation is vastly different than it was 10, even 5 years ago. Sponsors who are now transitioning to electronic collection realize it doesn’t have to be disruptive and is much simpler for investigative sites, patients and study teams.
And, consider that, in addition to the time savings that stem from electronic scale measurement, transcriptions, data entry, data queries and source data verifications, it’s much easier to update the seemingly inevitable mid-study design or protocol changes than it is with paper diaries. And, by leveraging a Bring Your Own Device (BYOD) approach to eCOA data capture, sponsors can further reduce logistical burden and costs during clinical trial implementation.
Go Electronic in Your Next Study
Research repeatedly shows that patients prefer electronic collection methods over paper1, trial sponsors see improved data quality, and global regulators routinely accept eCOA data collection in clinical trials. So, trial sponsors of all sizes should have confidence that they can adopt and implement an eCOA strategy successfully and take advantage of the many benefits it offers during clinical development.
Download our guide to learn how collecting data electronically can increase your study’s data quality, achieve 90%+ patient compliance and provide real-time insights into patient safety.
Zaher El-Assi is the Executive Vice President of eCOA at ERT
1. “EDC and eCOA/ePRO Market Dynamics and Service Provider Performance,” ISR, 2015
3. Food and Drug Administration, Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (FDA, Rockville, MD, December 2009)
4. “Patient Non-compliance with Paper Diaries,” Stone, A., British Medical Journal, 2002