We use our smartphones daily, but the adoption of ePRO in the pharmaceutical industry surprising still meets resistance. This opposition is still present even considering the increasing shift to ePRO in recent years. In my opinion, ePRO should be the gold standard for PRO data capture in clinical trials.

Currently there is has been an increase in reconsidering traditional data collection strategies in clinical trials. Due to the complications COVID-19 created worldwide, paper data collection strategies became even more difficult than previously. As a consequence the benefits of ePRO became obvious, proving the underestimated power ePRO has to offer. The higher demand for ePRO from companies not using electronic capture systems came as they saw patient compliance rates fall drastically. Companies who did not want to use ePRO before COVID-19 suddenly found themselves trying to quickly obtain this service to stabilize patient reported outcomes. It is important to mention many times the quality of the paper documents collected fell short of basic standards, adding yet another barrier to data collection.

The advantages over paper-based PROs include:

• Accuracy – By using direct validation methods
• Integrity – Electronic time stamps and audit trails help avoid “parking lot syndrome” (filing out the PRO just before the visit)
• Security – ePRO data is stored on secured servers with backup safeguards. Thus, can never be lost.
• Compliance – Use of automated notifications raises patient awareness and provides valuable feedback.
  In addition, the patient can integrate these important, but sometimes inconvenient, tasks better in their daily life.
• Speed – Data can directly be assessed, is available for remote review, and can be integrated in other systems.

Most importantly the FDA has officially stated ePROs are preferred over paper PROs. The increase in implementation of ePRO in clinical trials indicates electronic systems are effective in increasing the data capture benefits in clinical trials.

It is obvious that the advantages of ePRO will remain long after COVID-19 has passed, but the memories and outcome results during a pandemic when an electronic system was desperately needed and not used will remain much longer.

For more information please click here to contact me. Another information resource worthy of review is the European Medical Agency (EMA) reflection paper on expectations for electronic source data and the FDA’s  guidance for industry on patient-reported outcomes. ).

I look forward to supporting you with your ePRO goals.

Thomas Kissner (tkissner@gcp-service.com)
Phone: +49 (0)421 89 67 66 12