The benefits of electronic Clinical Outcome Assessment (eCOA) have been widely published for decades. Yet, nearly half of all studies that collect patient outcome data do so using primarily paper solutions.1
Researchers cite different reasons for clinging to paper COA, including the misunderstanding that eCOA is only suitable for large, global companies, but hundreds of small pharma, biotechs and CROs are benefitting from using eCOA in their clinical trials every day.
Here we demystify some other common eCOA myths and present the core advantages to all clinical trial sponsors, regardless of their size.
Myth: Paper COA data is reliable and has always worked
Myth busted! Paper methods are not reliable, as they offer no controls over data entry timeliness or quality. Paper-based patient reported outcomes (PRO) data are often incomplete (skipped items), illegible (poor handwriting) and illogical (inappropriate responses). All these situations present serious data analysis problems that are not an issue with electronic PRO (ePRO).
Further, patients using paper PRO routinely fail to comply with study protocols regarding scheduled data entry times, completing diaries in batches just prior to a site visit (termed ‘parking lot syndrome’). Patients also invent data by forward-filling paper diaries; research shows that 45% of patients in a pain study invented data by forward filling at least once.2
Patients using ePRO demonstrate significantly higher protocol compliance (as high as 94%, compared to 11% with paper2).
By eliminating out-of-range and incomplete responses and capturing data in real time, only ePRO delivers accurate, reliable information on patients’ experiences during a trial.
Myth: Regulators will not accept eCOA data in submissions
False! eCOA is routinely accepted by international regulators – in fact, ERT’s eCOA solution has supported over 50 new drug approvals to date ― and has been a critical factor in some. 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.3
Global and regional regulatory authorities have been publishing guidances and reflection papers on eSource, ePRO, and eCOA that paper processes simply cannot meet. 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."4
Myth: eCOA is too expensive
Not true! There is in an outdated notion that paper COA is less expensive than eCOA. Today, that’s simply not the case. The cost of poor quality data gleaned from paper collection and transposition can far outweigh the cost of eCOA data collection.
Consider how the reduced noise and data variance that comes from real-time eCOA data capture can translate into more efficient clinical research. 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. The reduction in error variance resulting from the use of 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 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. When accurately accounted for, labor costs for paper-based COA can actually eclipse anticipated eCOA costs.
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 currently transitioning from paper to electronic collection realize that it’s not disruptive and is much simpler for investigative sites, patients and study teams.
Sponsors should 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 during clinical trial implementation.
Research has repeatedly shown that patients prefer electronic collection methods over paper1, trial sponsors continue to see improved data quality, and global regulators routinely accept eCOA data collection in clinical trials. Trial sponsors of all sizes and levels of experience who want to adopt and implement an eCOA strategy can do so successfully by collaborating with study teams, eCOA providers and COA experts familiar with transitioning from paper-based COA data collection.
1. “EDC and eCOA/ePRO Market Dynamics and Service Provider Performance,” ISR, 2015.
2. “Patient Non-compliance with Paper Diaries,” Stone, A., British Medical Journal, 2002
3. ‘A PROfessional Trial”, McCallister, E., Biocentury, 2011
4. 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)
5. “Proving the eDiary Dividend,” McKenzie, S., Applied Clinical Trials, 2004
6.”Impact of Computerized Quality of Life Screening on Physician Behaviour and Patient Satisfaction in Lung Cancer Patients,” Taenzer, et al., 2000, Psychooncology, 9:203