Many sponsors and CROs aren’t sure what to expect when it comes to the cost of an Electronic Clinical Outcome Assessment (eCOA) platform, but the advantages of using eCOA are well documented. While upfront costs are a substantial consideration for sponsors and CROs, it’s important to remember that, overall, eCOA can decrease costs through a reduction in on-site monitoring time, less data cleaning, and improved patient retention. Costs can vary substantially based on the platform selected and the nature of the clinical trial. Here are some key cost drivers that will impact the cost of eCOA for a given study:
- The number of sites is one of the most important cost drivers because it touches almost all components of the budget—the number of devices that will be needed, the number of people that will need training, and the amount of support that will be needed, to name a few. Additionally, if some high enrolling sites require multiple devices, that will increase costs.
- The type of device used will also influence the total cost. Tread carefully, though—selecting a lower cost device at the outset can lead to hidden costs down the road. Replacing devices can be expensive, especially if it means that patient visits are rescheduled because a device isn’t available. Lower quality devices can also lead to investigator dissatisfaction, so it is important to balance device cost, quality, and desirability.
- The number and complexity of assessments will impact the cost. There will be costs associated with licensing assessments, implementing the assessments on the device, and conducting data review. Using an eCOA provider that also manages licensing can simplify the start-up process, creating both budget and timeline efficiencies. Consider carefully whether each assessment selected is truly needed. This will not only control the eCOA associated costs, but it will improve patient engagement and retention. Complex assessments may require additional set-up and development time.
- New or unique assessments will increase costs and may increase timelines. Existing assessments typically can be easily deployed and configured, but new or unique assessments require additional development, testing, and validation. If you are considering a novel endpoint or assessment, consider using an eCOA provider with in-house expertise in developing and validating assessments and endpoints.
- Geographic distribution of sites will affect the eCOA budget, particularly the number of countries and languages involved. For each new language, assessments and supporting materials will need translation. It may also require multi-language technical support. For certain assessments, cultural adaptation may be necessary to generate consistent results across cultures. eCOA suppliers with in-house translation capabilities may be more cost-effective and able to deliver on tighter timelines. Some countries will have import and logistics requirements that can increase costs. Global eCOA suppliers can provide insight on which countries have additional logistical hurdles and can help you overcome those hurdles.
- The amount of data review needed will influence the overall budget. The volume of data review depends on the number and type of assessments and the number of subjects. Additionally, when it comes to data review, the criticality of the data from the assessments is a consideration. Data collected through eCOA used in a primary or key secondary endpoint or to evaluate safety requires more scrutiny than exploratory data or data used to support subject eligibility. An experienced, knowledgeable vendor can offer a risk-based approach that maximizes quality with a cost-effective solution.
- Audio and video recording are important features that can improve data quality and can be used to examine whether entries were correctly recorded in the event of outlier data and to ensure assessment (rater) standardization across trial sites. Both deployment of these features and data review associated with the feature’s use may increase the cost, so consider where and how you choose to use it. The features can also be used to provide oversight and feedback to raters and determine which raters may need re-certification. Additionally, the sentinel effect, the penchant for people to perform better when they know they are being evaluated, may improve rater reliability.
- Study duration will affect cost as well, with longer study durations corresponding to increasing costs, especially with regards to on-going support costs. Expedited start-up times will often incur additional charges.
Like many eClinical technologies, eCOA does add to upfront costs; however, in most cases, those costs are offset by enhanced data quality, speed to database lock, and downstream cost savings. Are you considering eCOA for your next trial? Learn more about Pathway eCOA or contact us for a customized estimate.