Calculating ROI for ePRO

I recently delivered a webinar titled “Getting Started with eCOA/ePRO,” in which roughly a third of attendees polled cited expense as the number one reason that has prevented them from adopting an ePRO solution. So what does ePRO really cost? Is it worth it? Here I strive to provide a basic, high-level framework for thinking about the return on investment ROI of eCOA vs. paper.

Let’s start by taking a look at the costs that are unique to each approach.

Paper

In a traditional paper based model, you are incurring costs that stem from printing, mailing, data entry, and data cleaning. These are all expenses than can be estimated with a fair degree of accuracy, with the cost of data entry being the most significant of these. To estimate the cost of data entry, see how long it takes to key in a subject completed paper casebook, multiply this by your cost of labor (don’t forget to include overhead!).

ePRO

The cost side for ePRO is similarly straightforward, but the expense elements are different. You’re either building an ePRO system (which will almost carry a highly unpredictable cost) of buying one (much more predictable cost). Assuming you’re buying, here are the costs you may expect to incur:

· License
· Hosting
· Training and support
· Professional services (e.g. study configuration)
· Devices

You should evaluate whether your study and selected ePRO system will allow for patients to use their own devices, or if you will need to provision devices (or some mix thereof). The cost of provisioning devices, especially for a global study can be significant—in addition to the costs of the devices themselves, you will need to consider the costs of data plans, and logistics associated with supporting the devices. I’m a big fan of BYOD (bring your own device) but, depending on the study, it may not be feasible to utilize while maintaining scientific validity of data collected.

Once you’ve mapped out your costs of each route, you can begin to weigh these against the benefits of going eCOA.

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Paper vs. eCOA

When you boil it down, people employ ePRO/eCOA to maximize data quality, increase productivity, and/or enable new capabilities that help answer their research questions. ePRO is e-source, so you don’t have worry about administering a paper data entry process. Depending on the study, the cost savings from this alone might justify ePRO.

There are some additional benefits ePRO offers over paper that may be harder to quantify, but nonetheless  very real. For example, there are clear data quality benefits to ePRO. The electronic system can ensure a minimum standard of data quality through edit checks and enforced data structures. ePRO data will always be cleaner than the same data captured on paper.

Benefits and Motivations for eCOA

 

The use of an ePRO system also allows you to know for sure when the data were recorded. For instance, patients can be reminded automatically when their diaries are overdue, and you now only have much stronger assurances that data were collected at the appropriate time (vs paper), you can also more easily monitor the study progress.

Bypassing manual data entry and having the system provide notifications to subjects to ensure data are captured in a timely way might allow for faster and better in-study decision making and even may accelerate study closeout. Also, an increasing amount of evidence exists that mobile-based messaging and communication strategies help increase patient engagement and treatment adherence. And of course, not having to deal with a stack of paper during a site visit might allow the clinician’s interaction with the patient to be higher quality.

Quantifying the benefits of all of these things can be tough, but start with those which are most quantifiable and see if those items alone these alone provide a compelling ROI (from my experience they often do).  Then the less tangible benefits become gravy to the ROI argument.  When modeling costs over time and a pay-back period, keep in mind that ePRO will typically carry a higher upfront cost than paper, with the cost saving benefits realized downstream over time. With today’s technologies, even most smaller studies should be able to realize a positive payback.

Naturally, there may be additional ROI factors to consider which are specific to your situation. If you have particular thoughts, questions, or experiences on this topic I encourage you to add a comment to this post.

Free Webinar, Aug 27: Successful Part 11 Compliance in a Universe of Electronic Data

Regulatory compliance may not always be the life of the party, but understanding its basics and being prepared for some of its hoops is becoming increasingly important. With that in mind you may find this upcoming webinar on successful compliance quite helpful if you’re new to 21 CFR Part 11 or if you’re looking to learn what’s new in the clinical research data landscape.

Hosted by our friends at Bio-Optronics and presented by OpenClinica CEO Cal Collins (@CalCollins1) the webinar will:

  • Review the basics of 21 CFR Part 11 and related regulations.
  • Examine what data and systems are within the scope of Part 11 and which are tangential.
  • Discuss how both good tools and good processes are necessary to succeed in a Part 11-compliant environment.
  • Briefly explore the changing landscape of electronic data in healthcare, and what it means for research.

The webinar will feature a 45-minute presentation and 15 minutes of Q&A, so make sure to send your questions or tune in for additional compliance intel.

Update: This webinar is now available for download.

Successful Part 11 Compliance in a Universe of Electronic Data

Presenter: Cal Collins, CEO OpenClinica
Wednesday,  Aug 27, 2014
3:00 PM – 4:00 PM EDT

Webinar hosted by:

clinical_conductor

Webinar: Tablet-based Offline EDC for OpenClinica – July 24

Offline Data Capture for OpenClinica – Demo of Mi-Forms Tablet Integration with OpenClinica

Date: July 24, 2013
Time: 2:00PM – 3:00PM EST

Attend this webinar to see, first hand, the use of tablets in offline, disconnected settings to capture and verify CRF data, and transmit them back into OpenClinica. See how the Mi-Forms/OpenClinica integration allows for easy design, deployment and verification of data at the point of capture.

RegisterButtonAt this webinar you’ll discover how to:

  • Enable multi-site offline data capture
  • Reduce query rates & speed trial completion
  • Cut clinical trial costs with mobile data capture

Presenters:
Ben Baumann, OpenClinica COO
Chris DiPierro, Mi-Co Director of Software Development
Gautham Pandiyan, Mi-Co VP of Sales & Marketing