ePRO in Clinical Research: Debunking Common Objections

ePRO in Clinical Research: Debunking Common Objections

An ePRO system (electronic Patient Reported Outcomes) is a powerful Clinical Data Management tool for clinical research. It supports hybrid and decentralized trials, making it easier to recruit a diverse participant pool by removing location barriers. On top of that, it ensures consistent data entry, enhances compliance, and is cost-effective.

Yet, despite these clear benefits, many research teams still have doubts or objections about adopting an electronic Patient Reported Outcomes tool instead of traditional on-site visits and paper questionnaires. Even though response rates with ePRO are shown to be 20% higher, there are still concerns. In this article, we’ll address some of the most common objections and explain why an electronic Patient Reported Outcomes system is a reliable, efficient choice for your clinical trials.

Objection 1: Will the questionnaire email actually reach participants?

In clinical trials, it’s crucial that participants receive their scheduled diaries or questionnaires (like QoL, SF-36, or WHOQOL) on time. If emails don’t reach their inboxes, it can impact data collection. It’s understandable why this is a common concern when using ePRO. Thankfully, ePRO systems are designed with built-in monitoring to ensure that emails are delivered and questionnaires are completed.

Reality with ePRO

• Delivery confirmation:
  You can track the delivery status of every email sent to participants. The system allows you to see exactly who received the email, when it was opened, and whether it has been completed. This gives you peace of mind that your questionnaires are properly distributed.

• Real-time completion tracking:
  As a trial manager, you can monitor in real-time which participants have completed the digital questionnaire and who still has pending tasks. This makes it easy to follow up where needed and ensure timely data collection.

• Avoiding email blacklisting:
  Sending large volumes of emails from the same IP address can sometimes trigger spam filters. With ePRO, this risk is minimized. At ResearchManager, we take proactive steps to ensure that emails sent from our system reach participants’ inboxes and don’t end up in spam folders.

Objection 2: What if participants forget to complete the questionnaire?

When participants come in for an in-person visit, you know they’re engaged and present for the study. However, when they are asked to complete tasks at home, the risk of forgetting increases. A missed email or a delayed response is common. Thankfully, electronic Patient Reported Outcomes systems are built to address this.

Reality with ePRO

• Automated reminders:
  The electronic Patient Reported Outcomes system automatically sends reminder emails to participants who haven’t completed their questionnaires. As a trial manager, you don’t need to manually follow up, saving you time. These automated reminders are highly effective in prompting participants to complete their tasks.

Objection 3: How can we be sure the participant is the one completing the questionnaire?

When participants complete questionnaires on their smartphones, tablets, or laptops, it’s not immediately clear who is answering. You need confidence that the actual participant is the one providing responses. ePRO systems include several verification methods to ensure data integrity.

Reality with ePRO

• Email validation checks:
  Only the email recipient can access and complete the questionnaire. If the participant forwards the email to someone else, the questionnaire cannot be opened by anyone other than the intended recipient.

• IP address control:
  ePRO systems can limit questionnaire access based on IP addresses, which is useful for restricting access to specific geographic regions. Additionally, IP controls help prevent multiple submissions from the same participant, maintaining data accuracy.

• Pincode verification (optional):
  While some electronic Patient Reported Outcomes systems use PIN codes for additional verification, we found that this can reduce response rates. At ResearchManager, we utilize alternative verification methods that maintain high participation while ensuring data security.

Conclusion:
Many objections to electronic Patient Reported Outcomes systems stem from a lack of understanding of how these tools work. ePRO systems have multiple layers of safeguards—both visible and invisible—to ensure the integrity of your data. This makes them a reliable choice for distributing questionnaires and diaries in clinical trials while ensuring compliance and participant engagement.

Want to see how ePRO works for yourself? At ResearchManager, we offer demos.
Experience firsthand how emails are delivered, and the feedback you’ll receive as a clinical trial manager. Request a demo below, and we’ll walk you through our ePRO test environment to show how it meets your trial’s needs.