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The Potential Return on Investment of Using ePROS Over Paper in Clinical Trials

Studies show that electronic patient reporting yields higher quality data than paper-based diaries with electronic patient-reported outcomes (ePROs) driving greater participant compliance. With our behavioral science-driven platform, compliance rates are consistently above 90%, and retention rates are above 85% in our client’s clinical trials. For the past decade, both the FDA and EMA have begun to accept ePRO study data, and the number of trials using electronic data capture (EDC) and ePRO has grown steadily. Despite these advances and the general use of technology in every part of our lives, some clinical trials continue to use paper-based questionnaires.

Let’s dive deeper

When treatment outcomes need to be collected, A standard PRO instrument may be chosen, or a clinical trial project team may create a new one when collecting treatment outcomes. The team must then decide if they want participant responses on paper or electronically (ePRO). The trial’s cost and timeline are highly dependent on the number of instruments, the frequency of data collection, the patient population, and the indication being studied, so it is important to consider these factors when deciding the data collection method.

The industry perception is that the start-up costs of implementing an ePRO platform may dwarf the cost of printing and distributing paper diaries by as much as ten times. However, this does not take into consideration the significant value and return on investment that adopting ePRO technology, such as Datacubed Health’s Linkt, has had on overall clinical trial costs and timelines due to improvements in data quality and completeness, participant retention, and compliance, and study and site efficiency.

MEETING PARTICIPANTS WHERE THEY ARE

According to a 2017 survey from the ePRO Consortium, nearly half of respondents reported that patient receptivity or burden was a major consideration when determining whether to use paper surveys or ePRO. Unsurprisingly, the study also found that the majority of patients found ePRO systems easy to use and prefer them to paper.

Meeting participants where they are is key to the adoption of ePRO. Designed with a consumer-grade interface, the Datacubed Health Linkt app facilitates the easy collection of ePRO data from patients and is accessible through a personal or provisioned device. Operationally, the Bring Your Own Device (BYOD) model increases compliance by maximizing patient convenience and ease of ePRO completion.

ePRO vs Paper

Unlike paper solutions, Datacube’s ePRO/eDiary module is specifically designed to be easy to use and engaging, which encourages patient compliance and drives greater data completion and accuracy. A paper-based trial is more likely than one using ePRO to have incomplete, misleading, conflicting, or falsified participant responses. Such inaccuracies often require a sponsor’s study team, data managers, and site personnel to spend hours reviewing questionnaires, entering data, and seeking follow-up information. It can take weeks to months before errors on a paper questionnaire are discovered and by then, it is often too late to retrieve missing or corrected data. As a result, labor costs for a paper-based study often easily erase any savings projected for the use of paper.

Unlike paper, eDiary or ePRO data collected through Datacubed are immediately available for study staff (including sites) to review on the staff-facing component of the Admin Panel. Within this one system, study staff can review data collected in real-time and automate smartphone notifications, Linkt in-app messages and SMS messages to encourage patients to complete ePROs. For example, Linkt notifications can be configured to automatically remind patients to complete the ePRO if they have not done so within a specified period of time. And because ePRO reports are sent and reviewed in real time, the potential for lost, missing, and non-compliant data is significantly reduced. At the close of a study, ePRO data are already in the study database, speeding study close-out.

PATIENT COMPLIANCE & ENGAGEMENT

Another way ePRO technology like Linkt can reduce costs over paper is by improving compliance and retention rates. Foundational to the design of Linkt is the incorporation of short-, medium- and long-term motivators. Linkt is specifically designed to maintain patient engagement through the course of a clinical trial and helps sustain high retention and compliance levels in studies that require the collection of repeated data over short and long durations (i.e., a few days to weeks up to multiple years).

Linkt’s touch screens, intuitive page designs, and sophisticated graphical interfaces help sponsors design compelling questionnaires that trial participants find interesting and enjoyable, leading to compliance rates of over 90% compared to paper ePRO rates of ~30%.

Further, participants aged 50 and older show the most interest in these reinforcing elements. In fact, participants aged 55+ engage with the reinforcement elements of the Linkt platform up to 4 times as much as adults in their 20s. These data suggest older participants seek out the Linkt app, even outside of ePRO completion requirements. Leveraging this population’s interest in Linkt, by delivering the ePROs through Linkt, increases retention and compliance with respect to timely completion of study endpoints.

LET’S DO THE MATH

Imagine a study with a protocol that requires 300 participants to complete a paper diary once a day for nine months (279 days): 300 x 279 = 83,700 pages of data. With paper, as the volume of data collected grows, the costs grow as the study team must collate paper data, review and validate entries, and enter data into a sponsor or CRO’s electronic data capture (EDC) system.

By automating data functions, ePRO offers operational and financial advantages and puts the patient first in terms of convenience and ease of use. Also, consider that the average cost of an international clinical trial is approximately $40 million. If even one percent of enrolled participants drop out early, that’s a loss of $400,000. The average dropout rate for clinical trials is over 20 percent, which is a loss of at least $8 million dollars. Therefore, if a clinical trial could increase retention by even five percent, that would save $2 million.

The return on investment is clear. Begin your Datacubed Health journey today with a demo of our revolutionary ePRO/eCOA solution.