The Hidden Costs of Paper vs. eCOA in Clinical Trials

In clinical trials, the decision to use paper-based or electronic clinical outcome assessment (eCOA) solutions is often weighed through the lens of cost. On the surface, paper may seem like the more budget-friendly option. However, a deeper look reveals that paper-based systems come with hidden costs—ones that can significantly impact the success and efficiency of your trial.

eCOA, on the other hand, offers a modern solution that eliminates many of these hidden expenses while improving data quality and operational efficiency. Let's explore the true costs of paper and how eCOA can be a smarter choice for your next study.

The Hidden Costs of Paper-Based Systems

While paper systems may appear simple and cost-effective, they often result in unexpected challenges. These hidden costs can derail budgets and timelines in ways that aren’t immediately apparent.

Direct and indirect costs of paper COA

While eCOA solutions have costs associated with solution design and implementation, and hardware provision (where needed), paper-based COA is still associated with significant expenses, some of which are rarely measured directly. Paper questionnaires and diaries are associated with the same translations processes as eCOA, but also require printing and fulfilment activity, and packaging, shipment and logistics.  

Use of paper questionnaires and home diaries are associated with data entry / transcription activities, typically conducted by the site, and source data verification activity by the CRA.

Data discrepancies require management and monitoring through the usual query management processes. Paper versions require copies to be retained and archived, and it is not uncommon for paper versions to be lost before or after transcription. Misplaced, lost or incomplete forms can delay timelines, leading to additional costs. Aside from comparison of printing budgets, the increased human activities and processes required are rarely accounted for when comparing the cost of eCOA to the use of paper.

Data Quality and Integrity Challenges

Data transcription errors are common with paper systems. When site staff transcribe responses from paper into an electronic database, inconsistencies and inaccuracies can occur. These errors compromise data quality and add to the burden of site staff, ultimately requiring increased levels of monitoring and data management activities leading to costly and time-consuming data-cleaning efforts.

Another concern is the “parking lot effect.” Patients often complete paper questionnaires outside of the clinic, and in unsupervised conditions (e.g., at home completion) it is not possible to ensure the timeliness of questionnaire completion. This can undermine the accuracy and reliability of the data due to inaccurate recall. We see this in the “parking lot effect”, where patients fill in incomplete diaries just prior to handing them in during a clinic visit. This lack of real-time data capture can lead to lower-quality data, reducing the trial’s reliability.

Compliance Risks and Audit Challenges

Ensuring regulatory compliance with paper systems can be cumbersome. Missing signatures, missing header or footer information, illegible entries, and improperly completed forms are common issues, all of which can lead to costly audits and even jeopardize trial outcomes.

How eCOA Reduces the Hidden Costs of Paper

Switching to eCOA mitigates these challenges while delivering additional benefits that enhance trial efficiency and patient engagement.

Enhanced Data Quality

eCOA ensures that data is captured accurately and in real time, eliminating the need for manual transcription. Built-in validation rules guide patients through questionnaires, reducing the risk of errors and incomplete responses.

Real-time Monitoring and Patient Engagement

With eCOA, sponsors and CROs gain real-time visibility into patient responses, enabling proactive issue resolution. Features like reminders and user-friendly interfaces improve patient adherence and engagement, further boosting data quality.

Operational Efficiency

By digitizing data collection, eCOA eliminates the need for printing, shipping, and storing physical forms. This streamlines workflows and reduces costs across the trial lifecycle.

Faster Database Lock

eCOA accelerates database lock timelines by delivering cleaner data from the outset. This can shave weeks—or even months—off your trial timeline, saving time and money.

The ROI if eCOA

While the upfront cost of implementing eCOA may appear on the surface higher than paper, the long-term benefits far outweigh the initial investment. Consider this hypothetical example:

A mid-sized trial enrolling 1,000 patients across 50 sites would require significant resources for paper management, including logistics, data cleaning, and storage. By switching to eCOA, sponsors could save hundreds of thousands of dollars in operational costs while achieving faster, more reliable outcomes.

Investing in the Future of Clinical Trials

Paper-based systems may seem like the simpler option, but their hidden costs can add up quickly. eCOA offers a cost-effective alternative that improves data quality, operational efficiency, and patient engagement.

In a world where trial timelines are critical, choosing eCOA over paper isn’t just about reducing costs—it’s about delivering better trials, faster.

Take the next step in modernizing your clinical trials:
Learn more - eCOA in Clinical Trials: A Complete Implementation Guide>