No one likes being hit with hidden costs, whether it be from hotels, airlines, or home purchases. But at least in those cases, the hidden costs are eventually revealed. Even more pernicious are situations in which you never fully appreciate the extra cost of having chosen one option over another. Option A may appear to be more economical than option B, but only because the associated downstream costs are never systematically calculated and compared. The true costs are not so much hidden as simply not considered. This is the case with using hard-copy “paper” patient diaries in clinical trials rather than eCOAs, or an electronic solution to collect Clinical Outcome Assessments.
The true hard and hidden cost of paper diaries
The cost of paper itself and of printing and binding diaries isn’t high. It’s what happens after the printing that becomes an issue. A paper-based data-collection process racks up hard costs and hidden costs at every turn. Let’s put aside the cost of the potential detrimental effects on data quality and look just at the calculable cost of paper’s burden to sites and sponsors. A short list of the work required only when paper diaries are used includes:
- Preparing and distributing patient packets/subject binders
- Transcription of diary entries into the Electronic Data Capture (EDC) system, which typically entails deciphering handwriting and addressing missing data
- Measuring patients’ visual analog scales (VAS) by hand
- Source data verification (SDV)
- Data reconciliation
- Archiving hard-copy documents for 15 years or more, depending on the country’s regulations
The total costs of an eCOA system
On the flip side, using an eCOA, such as a patient reported outcomes (ePRO) tool, with an eDiary in clinical trials incurs costs for:
- Device provisioning, except with a bring-your-own-device (BYOD) study
- Software implementation and database programming
- Site- and study-level monitoring of patient engagement and compliance
- Software license fees
How paper diaries and eCOA compare
How do the two approaches compare in terms of cost? At Clinical ink, we not only offer a variety of digital clinical outcome solutions; we’ve also built a calculator that accounts for the costs associated with paper-based diaries vs. eDiaries from study set-up and maintenance through to database lock. In running the calculator on a number of studies with different parameters, we’ve found that using paper diaries is 30 percent to 50 percent more expensive than using eDiaries for patient reported outcomes. In one of our sample analyses, the sponsor saved $2 million by using an eDiary over a paper one.
More details on our calculator (how it works and what factors it considers) will be forthcoming, but we wanted to share the bottom-line results: it’s a false economy to use paper diaries over e-diaries. When patient-reported outcomes are included in a clinical trial, sponsors can save millions in hard costs by using an electronic source..
Find out more about how you can save using eCOA
If you are interested in our calculator’s findings for a proposed study of your own, please contact us.
Author: Rinah Yamamoto, Ph.D., Principal Scientist, Clinical ink